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Completed

NCT Number: NCT01559415

An Adipocyte-Driven Mechanism For Weight Regain After Weight Loss: The Yo-Yo Effect

Almost half of the Dutch population is currently characterized by overweight and obesity. Losing weight is not the problem in obesity treatment, it is the seemingly obligatory weight regain after weight loss: the yoyo-effect. The primary objective of this study is to investigate the association between the weight-loss-induced cellular stress response and the rate of weight regain. The secondary objective is to investigate the differences in cellular stress response and weight regain after rapid and slow weight loss. To investigate this, subjects will receive meal replacements replacing either all or part of the daily meals during the intervention period. THe first group will consume 500 kcal/d diet for 5 weeks while the second group consumes a 1250 kcal/d diet for 3 months, both followed by 1 week normalization and a 2 week strict weight maintenance diet. During the 9-month follow-up period subjects will receive dietary advice according to the Dutch recommendations for healthy eating. The association between the amount of weight regain after the weight loss period and changes in adipokines, parameters of adipocyte metabolism, in vivo adipose tissue metabolism, adipocyte extracellular matrix gene expression profiles, adipocyte stress protein expression and gene polymorphisms in selected genes.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Diet Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University

Maastricht, Limburg, 6200 MD, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age (years): 20-65
  • Body Mass Index (kg/m2): 28-35
  • Non-smokers

Exclusion criteria

  • Subjects using prescription medication, or suffering from diseases or conditions that might influence the outcome of the study: this concerns diseases/medication that influence body weight regulation (malabsorption, untreated hypo/hyperthyroidism, eating disorders, systemic use of steroids, etc.) and obesity-related cardiovascular risk factors (heart disease, systolic and diastolic blood pressures > 160/100 mmHg, blood glucose > 6.1 mmol L-1, blood cholesterol > 7 mmol L-1, blood triglycerides > 3 mmol L-1)
  • marked alcohol consumption > 21 alcoholic units week-1 (male), or >14 alcoholic units week-1 (female)
  • planned major changes in physical activity during the study to an extent that might interfere with the study outcome as judged by the investigator;
  • blood donation within the past 2 months prior to the study
  • weight change of >3 kg within 2 months prior to the study
  • psychiatric disease (based on medical history only)
  • pregnant or lactating women, or women planning to become pregnant within the next 12 months
  • surgically treated obesity
  • participation in other clinical studies within the last 3 months
  • drug abuse (based on clinical judgment)
  • unable to give informed consent
  • unable to engage in a low-calorie diet
  • unable to lose more then 8% of body weight after weight-loss period
  • following a special diet (vegetarian, Atkins or other).

Treatment and study plan

Meal replacement diet using Modifast

Other

modifast intensive diet replacing all regular meals (500 kcal/d) for 5 weeks

Normal diet combined with Modifast diet

Other

Combination of modifast and regular diet (1250 kcal/d) for 3 months

Primary outcomes

  1. change in weight following weight loss

    Time frame: at 9 weeks and at 46 weeks

    VLCD diet group

  2. change in weight following weight loss

    Time frame: at 16 weeks and at 53 weeks

    LCD diet group

Secondary outcomes

  1. change in adipokine profile due to dietary intervention (VLCD-group)

    Time frame: at baseline and after 5 weeks of VLCD diet

    In VLCD-group.

    Parameters of adipokine profile, including:

    leptin, acylation stimulating protein (ASP/C3adesarg), adiponectin, resistin, IL-6, RBP4, PAI-1, ACE, FGF-21, Vaspin, Apelin, Nesfatin-1 and TNFa

  2. change in adipokine during weight stable-period (VLCD-group)

    Time frame: after 5 weeks of VLCD diet and after 9 weeks

    In VLCD-group.

    Parameters of adipokine profile, including:

    leptin, acylation stimulating protein (ASP/C3adesarg), adiponectin, resistin, IL-6, RBP4, PAI-1, ACE, FGF-21, Vaspin, Apelin, Nesfatin-1 and TNFa

  3. change in adipokine profile during follow-up (VLCD-group)

    Time frame: at 9 weeks and after follow-up at 46 weeks

    In VLCD-group.

    Parameters of adipokine profile, including:

    leptin, acylation stimulating protein (ASP/C3adesarg), adiponectin, resistin, IL-6, RBP4, PAI-1, ACE, FGF-21, Vaspin, Apelin, Nesfatin-1 and TNFa

  4. change in adipokine profile due to dietary intervention (LCD-group)

    Time frame: at baseline and after 12 weeks of LCD diet

    In LCD-group.

    Parameters of adipokine profile, including:

    leptin, acylation stimulating protein (ASP/C3adesarg), adiponectin, resistin, IL-6, RBP4, PAI-1, ACE, FGF-21, Vaspin, Apelin, Nesfatin-1 and TNFa

  5. change in adipokine profile during weight-stable period (LCD-group)

    Time frame: after 12 weeks of LCD diet and at 16 weeks

    In LCD-group.

    Parameters of adipokine profile, including:

    leptin, acylation stimulating protein (ASP/C3adesarg), adiponectin, resistin, IL-6, RBP4, PAI-1, ACE, FGF-21, Vaspin, Apelin, Nesfatin-1 and TNFa

  6. change in adipokine profile during follow-up (LCD-group)

    Time frame: at 16 weeks and after follow-up at 53 weeks

    In LCD-group.

    Parameters of adipokine profile, including:

    leptin, acylation stimulating protein (ASP/C3adesarg), adiponectin, resistin, IL-6, RBP4, PAI-1, ACE, FGF-21, Vaspin, Apelin, Nesfatin-1 and TNFa

  7. Changes in adipokine profile in the LCD-group compared to the VLCD-group

    Time frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks

    In LCD-group.

    Parameters of adipokine profile, including:

    leptin, acylation stimulating protein (ASP/C3adesarg), adiponectin, resistin, IL-6, RBP4, PAI-1, ACE, FGF-21, Vaspin, Apelin, Nesfatin-1 and TNFa

  8. change in adipokine profile in relation to weight regain during follow-up

    Time frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks

    In LCD-group and VLCD-group

    Parameters of adipokine profile, including:

    leptin, acylation stimulating protein (ASP/C3adesarg), adiponectin, resistin, IL-6, RBP4, PAI-1, ACE, FGF-21, Vaspin, Apelin, Nesfatin-1 and TNFa

  9. change in parameters of adipocyte fat metabolism due to dietary intervention (VLCD-group)

    Time frame: at baseline and after 5 weeks of VLCD diet

    In VLCD-group.

    Parameters of adipocyte fat metabolism:

    • ALDOC, phospho-annexin2, FABP4, PLIN-B, HADH, phosphorylated HSL and non-phosphorylated HSL - immunohistochemical staining of GLUT-4
    • Micro-array analysis of gene expression profile

  10. change in parameters of adipocyte fat metabolism during weight-stable period (VLCD-group)

    Time frame: after 5 weeks of VLCD diet and at 9 weeks

    In VLCD-group.

    Parameters of adipocyte fat metabolism:

    • ALDOC, phospho-annexin2, FABP4, PLIN-B, HADH, phosphorylated HSL and non-phosphorylated HSL - immunohistochemical staining of GLUT-4
    • Micro-array analysis of gene expression profile

  11. change in parameters of adipocyte fat metabolism during follow-up period (VLCD-group)

    Time frame: at 9 weeks and after follow-up at 46 weeks

    In VLCD-group.

    Parameters of adipocyte fat metabolism:

    • ALDOC, phospho-annexin2, FABP4, PLIN-B, HADH, phosphorylated HSL and non-phosphorylated HSL - immunohistochemical staining of GLUT-4
    • Micro-array analysis of gene expression profile

  12. change in parameters of adipocyte fat metabolism due to dietary intervention (LCD-group)

    Time frame: at baseline and after 12 weeks of LCD diet

    In LCD-group.

    Parameters of adipocyte fat metabolism:

    • ALDOC, phospho-annexin2, FABP4, PLIN-B, HADH, phosphorylated HSL and non-phosphorylated HSL - immunohistochemical staining of GLUT-4
    • Micro-array analysis of gene expression profile

  13. change in parameters of adipocyte fat metabolism during weight-stable period (LCD-group)

    Time frame: after 12 weeks of LCD diet and at 16 weeks

    In LCD-group.

    Parameters of adipocyte fat metabolism:

    • ALDOC, phospho-annexin2, FABP4, PLIN-B, HADH, phosphorylated HSL and non-phosphorylated HSL - immunohistochemical staining of GLUT-4
    • Micro-array analysis of gene expression profile

  14. change in parameters of adipocyte fat metabolism during follow-up (LCD-group)

    Time frame: at 16 weeks and after follow-up at 53 weeks

    In LCD-group.

    Parameters of adipocyte fat metabolism:

    • ALDOC, phospho-annexin2, FABP4, PLIN-B, HADH, phosphorylated HSL and non-phosphorylated HSL - immunohistochemical staining of GLUT-4
    • Micro-array analysis of gene expression profile

  15. Changes in parameters of adipocyte fat metabolism in the LCD-group compared to the VLCD-group

    Time frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks

    Parameters of adipocyte fat metabolism:

    • ALDOC, phospho-annexin2, FABP4, PLIN-B, HADH, phosphorylated HSL and non-phosphorylated HSL - immunohistochemical staining of GLUT-4
    • Micro-array analysis of gene expression profile

  16. change in parameters of adipocyte fat metabolism in relation to weight regain during follow-up

    Time frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks

    In LCD-group and VLCD-group.

    Parameters of adipocyte fat metabolism:

    • ALDOC, phospho-annexin2, FABP4, PLIN-B, HADH, phosphorylated HSL and non-phosphorylated HSL - immunohistochemical staining of GLUT-4
    • Micro-array analysis of gene expression profile

  17. change in in-vivo adipose tissue metabolism due to dietary intervention (VLCD-group)

    Time frame: at baseline and after 5 weeks of VLCD diet

    In VLCD-group.

    In-vivo adipose tissue metabolism assessed in fasting and postprandial conditions:

    • adipose tissue blood flow
    • adipose tissue PO2
    • adipose tissue oxygen consumption
    • adipose tissue capacity for fat uptake from chylomicron-triglycerides

  18. change in in-vivo adipose tissue metabolism during weight-stable period (VLCD-group)

    Time frame: after 5 weeks of VLCD diet and at 9 weeks

    In VLCD-group.

    In-vivo adipose tissue metabolism assessed in fasting and postprandial conditions:

    • adipose tissue blood flow
    • adipose tissue PO2
    • adipose tissue oxygen consumption
    • adipose tissue capacity for fat uptake from chylomicron-triglycerides

  19. change in in-vivo adipose tissue metabolism during follow-up period (VLCD-group)

    Time frame: at 9 weeks and after follow-up period at 46 weeks

    In VLCD-group.

    In-vivo adipose tissue metabolism assessed in fasting and postprandial conditions:

    • adipose tissue blood flow
    • adipose tissue PO2
    • adipose tissue oxygen consumption
    • adipose tissue capacity for fat uptake from chylomicron-triglycerides

  20. change in in-vivo adipose tissue metabolism due to dietary intervention (LCD-group)

    Time frame: at baseline and after 12 weeks of LCD diet

    In LCD-group.

    In-vivo adipose tissue metabolism assessed in fasting and postprandial conditions:

    • adipose tissue blood flow
    • adipose tissue PO2
    • adipose tissue oxygen consumption
    • adipose tissue capacity for fat uptake from chylomicron-triglycerides

  21. change in in-vivo adipose tissue metabolism during weight-stable period (LCD-group)

    Time frame: after 12 weeks of LCD diet and at 16 weeks

    In LCD-group.

    In-vivo adipose tissue metabolism assessed in fasting and postprandial conditions:

    • adipose tissue blood flow
    • adipose tissue PO2
    • adipose tissue oxygen consumption
    • adipose tissue capacity for fat uptake from chylomicron-triglycerides

  22. change in in-vivo adipose tissue metabolism during follow-up period (LCD-group)

    Time frame: at 16 weeks and after follow-up period at 53 weeks

    In LCD-group.

    In-vivo adipose tissue metabolism assessed in fasting and postprandial conditions:

    • adipose tissue blood flow
    • adipose tissue PO2
    • adipose tissue oxygen consumption
    • adipose tissue capacity for fat uptake from chylomicron-triglycerides

  23. change in in-vivo adipose tissue metabolism in the LCD-group compared to the VLCD-group

    Time frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks

    In-vivo adipose tissue metabolism assessed in fasting and postprandial conditions:

    • adipose tissue blood flow
    • adipose tissue PO2
    • adipose tissue oxygen consumption
    • adipose tissue capacity for fat uptake from chylomicron-triglycerides

  24. change in in-vivo adipose tissue metabolism in relation to weight regain during follow-up

    Time frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks

    In LCD-group and VLCD-group

    In-vivo adipose tissue metabolism assessed in fasting and postprandial conditions:

    • adipose tissue blood flow
    • adipose tissue PO2
    • adipose tissue oxygen consumption
    • adipose tissue capacity for fat uptake from chylomicron-triglycerides

  25. change in the adipocyte extracellular matrix gene and protein expression profile due to dietary intervention (VLCD-group)

    Time frame: at baseline and after 5 weeks of VLCD diet

    VLCD diet group

    Adipocyte extracellular matrix gene expression profile assessed:

    • micro-arrays on RNA expression
    • protein expression
    • Genetic polymorphisms: focus on polymorphisms in genes (a) that are preferentially expressed in white adipose tissue like TIMP4, (b) that have a proposed anchoring role of the cells to the basal lamina like the non-fibrillar type collagens IV and VI, (c) that are essential for adipose tissue development like MMP14, and (d) for which association has been found with obesity or adiposity like TIMP1, MMP2 and MMP9

  26. change in the adipocyte extracellular matrix gene and protein expression profile during weight-stable period (VLCD-group)

    Time frame: after 5 weeks of VLCD diet and at 9 weeks

    VLCD diet group

    Adipocyte extracellular matrix gene expression profile assessed:

    • micro-arrays on RNA expression
    • protein expression
    • Genetic polymorphisms: focus on polymorphisms in genes (a) that are preferentially expressed in white adipose tissue like TIMP4, (b) that have a proposed anchoring role of the cells to the basal lamina like the non-fibrillar type collagens IV and VI, (c) that are essential for adipose tissue development like MMP14, and (d) for which association has been found with obesity or adiposity like TIMP1, MMP2 and MMP9

  27. change in the adipocyte extracellular matrix gene and protein expression profile during follow-up period (VLCD-group)

    Time frame: at 9 weeks and after follow-up period at 46 weeks

    VLCD diet group

    Adipocyte extracellular matrix gene expression profile assessed:

    • micro-arrays on RNA expression
    • protein expression
    • Genetic polymorphisms: focus on polymorphisms in genes (a) that are preferentially expressed in white adipose tissue like TIMP4, (b) that have a proposed anchoring role of the cells to the basal lamina like the non-fibrillar type collagens IV and VI, (c) that are essential for adipose tissue development like MMP14, and (d) for which association has been found with obesity or adiposity like TIMP1, MMP2 and MMP9

  28. change in the adipocyte extracellular matrix gene and protein expression profile due to dietary intervention (LCD-group)

    Time frame: at baseline and after 12 weeks of LCD diet

    LCD diet group

    Adipocyte extracellular matrix gene expression profile assessed:

    • micro-arrays on RNA expression
    • protein expression
    • Genetic polymorphisms: focus on polymorphisms in genes (a) that are preferentially expressed in white adipose tissue like TIMP4, (b) that have a proposed anchoring role of the cells to the basal lamina like the non-fibrillar type collagens IV and VI, (c) that are essential for adipose tissue development like MMP14, and (d) for which association has been found with obesity or adiposity like TIMP1, MMP2 and MMP9

  29. change in the adipocyte extracellular matrix gene and protein expression profile during weight-stable period (LCD-group)

    Time frame: after 12 weeks of LCD diet and at 16 weeks

    LCD diet group

    Adipocyte extracellular matrix gene expression profile assessed:

    • micro-arrays on RNA expression
    • protein expression
    • Genetic polymorphisms: focus on polymorphisms in genes (a) that are preferentially expressed in white adipose tissue like TIMP4, (b) that have a proposed anchoring role of the cells to the basal lamina like the non-fibrillar type collagens IV and VI, (c) that are essential for adipose tissue development like MMP14, and (d) for which association has been found with obesity or adiposity like TIMP1, MMP2 and MMP9

  30. change in the adipocyte extracellular matrix gene and protein expression profile during follow-up period (LCD-group)

    Time frame: at 16 weeks and after follow-up period

    LCD diet group

    Adipocyte extracellular matrix gene expression profile assessed:

    • micro-arrays on RNA expression
    • protein expression
    • Genetic polymorphisms: focus on polymorphisms in genes (a) that are preferentially expressed in white adipose tissue like TIMP4, (b) that have a proposed anchoring role of the cells to the basal lamina like the non-fibrillar type collagens IV and VI, (c) that are essential for adipose tissue development like MMP14, and (d) for which association has been found with obesity or adiposity like TIMP1, MMP2 and MMP9

  31. change in the adipocyte extracellular matrix gene and protein expression profile in the LCD-group compared to the VLCD-group

    Time frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks

    Adipocyte extracellular matrix gene expression profile assessed:

    • micro-arrays on RNA expression
    • protein expression
    • Genetic polymorphisms: focus on polymorphisms in genes (a) that are preferentially expressed in white adipose tissue like TIMP4, (b) that have a proposed anchoring role of the cells to the basal lamina like the non-fibrillar type collagens IV and VI, (c) that are essential for adipose tissue development like MMP14, and (d) for which association has been found with obesity or adiposity like TIMP1, MMP2 and MMP9

  32. change in the adipocyte extracellular matrix gene and protein expression profile in relation to weight regain during follow-up

    Time frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks

    In LCD-group and VLCD-group

    Adipocyte extracellular matrix gene expression profile assessed:

    • micro-arrays on RNA expression
    • protein expression
    • Genetic polymorphisms: focus on polymorphisms in genes (a) that are preferentially expressed in white adipose tissue like TIMP4, (b) that have a proposed anchoring role of the cells to the basal lamina like the non-fibrillar type collagens IV and VI, (c) that are essential for adipose tissue development like MMP14, and (d) for which association has been found with obesity or adiposity like TIMP1, MMP2 and MMP9

  33. change in adipocyte stress proteins expression due to dietary intervention (VLCD-group)

    Time frame: at baseline and after 5 weeks of VLCD diet

    VLCD diet group

    Adipocyte stress proteins expression:

    • components of stress fibers and focal adhesions, like integrins
    • 43 'stress proteins' with focus on 9 stress proteins: actin betaactin, gamma 1, Rho GDP dissociation inhibitor (GDI), alphacofilin 1 (non-muscle), keratin 8, stathmin 1/oncoprotein 18, tropomyosin 3, vimentin, tubulin beta

  34. change in adipocyte stress proteins expression during weight-stable period (VLCD-group)

    Time frame: after 5 weeks of VLCD diet and at 9 weeks

    VLCD diet group

    Adipocyte stress proteins expression:

    • components of stress fibers and focal adhesions, like integrins
    • 43 'stress proteins' with focus on 9 stress proteins: actin betaactin, gamma 1, Rho GDP dissociation inhibitor (GDI), alphacofilin 1 (non-muscle), keratin 8, stathmin 1/oncoprotein 18, tropomyosin 3, vimentin, tubulin beta

  35. change in adipocyte stress proteins expression during follow-up period (VLCD-group)

    Time frame: at 9 weeks and after follow-up period at week 46

    VLCD diet group

    Adipocyte stress proteins expression:

    • components of stress fibers and focal adhesions, like integrins
    • 43 'stress proteins' with focus on 9 stress proteins: actin betaactin, gamma 1, Rho GDP dissociation inhibitor (GDI), alphacofilin 1 (non-muscle), keratin 8, stathmin 1/oncoprotein 18, tropomyosin 3, vimentin, tubulin beta

  36. change in adipocyte stress proteins expression due to dietary intervention (LCD-group)

    Time frame: at baseline and after 12 weeks of LCD diet

    LCD diet group

    Adipocyte stress proteins expression:

    • components of stress fibers and focal adhesions, like integrins
    • 43 'stress proteins' with focus on 9 stress proteins: actin betaactin, gamma 1, Rho GDP dissociation inhibitor (GDI), alphacofilin 1 (non-muscle), keratin 8, stathmin 1/oncoprotein 18, tropomyosin 3, vimentin, tubulin beta

  37. change in adipocyte stress proteins expression during weight-stable period (LCD-group)

    Time frame: after 12 weeks of LCD diet and at week 16

    LCD diet group

    Adipocyte stress proteins expression:

    • components of stress fibers and focal adhesions, like integrins
    • 43 'stress proteins' with focus on 9 stress proteins: actin betaactin, gamma 1, Rho GDP dissociation inhibitor (GDI), alphacofilin 1 (non-muscle), keratin 8, stathmin 1/oncoprotein 18, tropomyosin 3, vimentin, tubulin beta

  38. change in adipocyte stress proteins expression during follow-up period (LCD-group)

    Time frame: at week 16 and after follow-up period at 53 weeks

    LCD diet group

    Adipocyte stress proteins expression:

    • components of stress fibers and focal adhesions, like integrins
    • 43 'stress proteins' with focus on 9 stress proteins: actin betaactin, gamma 1, Rho GDP dissociation inhibitor (GDI), alphacofilin 1 (non-muscle), keratin 8, stathmin 1/oncoprotein 18, tropomyosin 3, vimentin, tubulin beta

  39. change in adipocyte stress proteins expression in the LCD-group compared to the VLCD-group

    Time frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks

    Adipocyte stress proteins expression:

    • components of stress fibers and focal adhesions, like integrins
    • 43 'stress proteins' with focus on 9 stress proteins: actin betaactin, gamma 1, Rho GDP dissociation inhibitor (GDI), alphacofilin 1 (non-muscle), keratin 8, stathmin 1/oncoprotein 18, tropomyosin 3, vimentin, tubulin beta

  40. change in adipocyte stress proteins expression in relation to weight regain during follow-up

    Time frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks

    In LCD-group and VLCD-group

    Adipocyte stress proteins expression:

    • components of stress fibers and focal adhesions, like integrins
    • 43 'stress proteins' with focus on 9 stress proteins: actin betaactin, gamma 1, Rho GDP dissociation inhibitor (GDI), alphacofilin 1 (non-muscle), keratin 8, stathmin 1/oncoprotein 18, tropomyosin 3, vimentin, tubulin beta

  41. change in physiological parameters due to dietary intervention (VLCD-group)

    Time frame: at baseline and after 5 weeks of VLCD diet

    Physiological parameters:

    Blood pressure, waist-, and hip-circumference, weight, BMI, age, body fat

  42. change in physiological parameters during weight-stable period (VLCD-group)

    Time frame: after 5 weeks of VLCD diet and at 9 weeks

    Physiological parameters:

    Blood pressure, waist-, and hip-circumference, weight, BMI, age, body fat

  43. change in physiological parameters during follow-up period (VLCD-group)

    Time frame: at 9 weeks and after follow-up at 46 weeks

    Physiological parameters:

    Blood pressure, waist-, and hip-circumference, weight, BMI, age, body fat

  44. change in physiological parameters due to dietary intervention (LCD-group)

    Time frame: at baseline and after 12 weeks of LCD diet

    Physiological parameters:

    Blood pressure, waist-, and hip-circumference, weight, BMI, age, body fat

  45. change in physiological parameters during weight-stable period (LCD-group)

    Time frame: after 12 weeks of LCD diet and at 16 weeks

    Physiological parameters:

    Blood pressure, waist-, and hip-circumference, weight, BMI, age, body fat

  46. change in physiological parameters during follow-up (LCD-group)

    Time frame: at 16 weeks and after follow-up at 53 weeks

    Physiological parameters:

    Blood pressure, waist-, and hip-circumference, weight, BMI, age, body fat

  47. Changes in physiological parameters in the LCD-group compared to the VLCD-group

    Time frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks

    Physiological parameters:

    Blood pressure, waist-, and hip-circumference, weight, BMI, age, body fat

  48. Changes in physiological parameters in relation to weight regain during follow-up

    Time frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks

    Physiological parameters:

    Blood pressure, waist-, and hip-circumference, weight, BMI, age, body fat

  49. change in plasma metabolic parameters due to dietary intervention (VLCD-group)

    Time frame: at baseline and after 5 weeks of VLCD diet

    Plasma metabolic parameters are measured in fasting and postprandial conditions, focused on:

    Glucose, insulin, free fatty acid, glycerol and triglycerides

  50. change in plasma metabolic parameters during weight-stable period (VLCD-group)

    Time frame: after 5 weeks of VLCD diet and at 9 weeks

    Plasma metabolic parameters are measured in fasting and postprandial conditions, focused on:

    Glucose, insulin, free fatty acid, glycerol and triglycerides

  51. change in plasma metabolic parameters during follow-up period (VLCD-group)

    Time frame: at 9 weeks and after follow-up at 46 weeks

    Plasma metabolic parameters are measured in fasting and postprandial conditions, focused on:

    Glucose, insulin, free fatty acid, glycerol and triglycerides

  52. change in plasma metabolic parameters due to dietary intervention (LCD-group)

    Time frame: at baseline and after 12 weeks of LCD diet

    Plasma metabolic parameters are measured in fasting and postprandial conditions, focused on:

    Glucose, insulin, free fatty acid, glycerol and triglycerides

  53. change in plasma metabolic parameters during weight-stable period (LCD-group)

    Time frame: after 12 weeks of LCD diet and at 16 weeks

    Plasma metabolic parameters are measured in fasting and postprandial conditions, focused on:

    Glucose, insulin, free fatty acid, glycerol and triglycerides

  54. change in plasma metabolic parameters during follow-up (LCD-group)

    Time frame: at 16 weeks and after follow-up at 53 weeks

    Plasma metabolic parameters are measured in fasting and postprandial conditions, focused on:

    Glucose, insulin, free fatty acid, glycerol and triglycerides

  55. Changes in plasma metabolic parameters in the LCD-group compared to the VLCD-group

    Time frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks

    Plasma metabolic parameters are measured in fasting and postprandial conditions, focused on:

    Glucose, insulin, free fatty acid, glycerol and triglycerides

  56. Changes in plasma metabolic parameters in relation to weight regain during follow-up

    Time frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks

    In LCD-group and VLCD-group

    Plasma metabolic parameters are measured in fasting and postprandial conditions, focused on:

    Glucose, insulin, free fatty acid, glycerol and triglycerides

  57. change in fat cell size and fat cell number due to the dietary intervention (VLCD-group)

    Time frame: at baseline and after 5 weeks of VLCD diet

  58. change in fat cell size and fat cell number during weight-stable period (VLCD-group)

    Time frame: after 5 weeks of VLCD diet and at 9 weeks

  59. change in fat cell size and fat cell number during follow-up period (VLCD-group)

    Time frame: at 9 weeks and after follow-up at 46 weeks

  60. change in fat cell size and fat cell number due to dietary intervention (LCD-group)

    Time frame: at baseline and after 12 weeks of LCD diet

  61. change in fat cell size and fat cell number during weight-stable period (LCD-group)

    Time frame: after 12 weeks of LCD diet and at 16 weeks

  62. change in fat cell size and fat cell number during follow-up (LCD-group)

    Time frame: at 16 weeks and after follow-up at 53 weeks

  63. Changes in fat cell size and fat cell number in the LCD-group compared to the VLCD-group

    Time frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks

  64. Changes in fat cell size and fat cell number in relation to weight regain after weight loss

    Time frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks

    In LCD-group and VLCD-group

  65. change in breath volatile organic compounds due to the dietary intervention (VLCD-group)

    Time frame: at baseline and after 5 weeks of VLCD diet

  66. change in breath volatile organic compounds during weight-stable period (VLCD-group)

    Time frame: after 5 weeks of VLCD diet and at 9 weeks

  67. change in breath volatile organic compounds during follow-up period (VLCD-group)

    Time frame: at 9 weeks and after follow-up at 46 weeks

  68. change in breath volatile organic compounds due to dietary intervention (LCD-group)

    Time frame: at baseline and after 12 weeks of LCD diet

  69. change in breath volatile organic compounds during weight-stable period (LCD-group)

    Time frame: after 12 weeks of LCD diet and at 16 weeks

  70. change in breath volatile organic compounds during follow-up (LCD-group)

    Time frame: at 16 weeks and after follow-up at 53 weeks

  71. Changes in breath volatile organic compounds in the LCD-group compared to the VLCD-group

    Time frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks

  72. Changes in breath volatile organic compounds in relation to weight regain during follow-up

    Time frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks

    In LCD-group and VLCD-group

  73. change in inflammatory parameters due to the dietary intervention (VLCD-group)

    Time frame: at baseline and after 5 weeks of VLCD diet

    In VLCD-group.

    Inflammatory parameters are analyzed in:

    • Plasma (including: TNF-a, IL-6, IL-8 and MCP-1)
    • Micro-array
    • PCR: (including: TNF-a, IL-6, IL-8 and MCP-1)

  74. change in inflammatory parameters during weight-stable period (VLCD-group)

    Time frame: after 5 weeks of VLCD diet and at 9 weeks

    In VLCD-group.

    Inflammatory parameters are analyzed in:

    • Plasma (including: TNF-a, IL-6, IL-8 and MCP-1)
    • Micro-array
    • PCR: (including: TNF-a, IL-6, IL-8 and MCP-1)

  75. change in inflammatory parameters during follow-up period (VLCD-group)

    Time frame: at 9 weeks and after follow-up at 46 weeks

    In VLCD-group.

    Inflammatory parameters are analyzed in:

    • Plasma (including: TNF-a, IL-6, IL-8 and MCP-1)
    • Micro-array
    • PCR: (including: TNF-a, IL-6, IL-8 and MCP-1)

  76. change in inflammatory parameters due to dietary intervention (LCD-group)

    Time frame: at baseline and after 12 weeks of LCD diet

    In LCD-group.

    Inflammatory parameters are analyzed in:

    • Plasma (including: TNF-a, IL-6, IL-8 and MCP-1)
    • Micro-array
    • PCR: (including: TNF-a, IL-6, IL-8 and MCP-1)

  77. change in inflammatory parameters during weight-stable period (LCD-group)

    Time frame: after 12 weeks of LCD diet and at 16 weeks

    In LCD-group.

    Inflammatory parameters are analyzed in:

    • Plasma (including: TNF-a, IL-6, IL-8 and MCP-1)
    • Micro-array
    • PCR: (including: TNF-a, IL-6, IL-8 and MCP-1)

  78. change in inflammatory parameters during follow-up (LCD-group)

    Time frame: at 16 weeks and after follow-up at 53 weeks

    In LCD-group.

    Inflammatory parameters are analyzed in:

    • Plasma (including: TNF-a, IL-6, IL-8 and MCP-1)
    • Micro-array
    • PCR: (including: TNF-a, IL-6, IL-8 and MCP-1)

  79. Changes in inflammatory parameters in the LCD-group compared to the VLCD-group

    Time frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks

    Inflammatory parameters are analyzed in:

    • Plasma (including: TNF-a, IL-6, IL-8 and MCP-1)
    • Micro-array
    • PCR: (including: TNF-a, IL-6, IL-8 and MCP-1)

  80. Changes in inflammatory parameters in relation to weight regain during the follow-up

    Time frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks

    Inflammatory parameters are analyzed in:

    • Plasma (including: TNF-a, IL-6, IL-8 and MCP-1)
    • Micro-array
    • PCR: (including: TNF-a, IL-6, IL-8 and MCP-1)

  81. Changes in protein concentration of metabolic parameters due to the dietary intervention (VLCD-group)

    Time frame: at baseline and after 5 weeks of VLCD diet

    Protein concentrations of metabolic parameters, including:

    CD36, FABP4, Vimentin, Vimentin25, HSL, ALDOC, ALDOA, TUBB5, ANXA2, HADH, ACAA2 and ACADS

  82. Changes in protein concentration of metabolic parameters during weight-stable period (VLCD-group)

    Time frame: after 5 weeks of VLCD diet and at 9 weeks

    Protein concentrations of metabolic parameters, including:

    CD36, FABP4, Vimentin, Vimentin25, HSL, ALDOC, ALDOA, TUBB5, ANXA2, HADH, ACAA2 and ACADS

  83. change in protein concentration of metabolic parameters during follow-up (VLCD-group)

    Time frame: at 9 weeks and after follow-up at 46 weeks

    Protein concentrations of metabolic parameters, including:

    CD36, FABP4, Vimentin, Vimentin25, HSL, ALDOC, ALDOA, TUBB5, ANXA2, HADH, ACAA2 and ACADS

  84. change in protein concentration of metabolic parameters due to dietary intervention (LCD-group)

    Time frame: at baseline and after 12 weeks of LCD diet

    Protein concentrations of metabolic parameters, including:

    CD36, FABP4, Vimentin, Vimentin25, HSL, ALDOC, ALDOA, TUBB5, ANXA2, HADH, ACAA2 and ACADS

  85. change in protein concentration of metabolic parameters during weight-stable period (LCD-group)

    Time frame: after 12 weeks of LCD diet and at 16 weeks

    Protein concentrations of metabolic parameters, including:

    CD36, FABP4, Vimentin, Vimentin25, HSL, ALDOC, ALDOA, TUBB5, ANXA2, HADH, ACAA2 and ACADS

  86. change in protein concentration of metabolic parameters during follow-up (LCD-group)

    Time frame: at 16 weeks and after follow-up at 53 weeks

    Protein concentrations of metabolic parameters, including:

    CD36, FABP4, Vimentin, Vimentin25, HSL, ALDOC, ALDOA, TUBB5, ANXA2, HADH, ACAA2 and ACADS

  87. change in protein concentration of metabolic parameters in the LCD-group compared to the VLCD-group

    Time frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks

    Protein concentrations of metabolic parameters, including:

    CD36, FABP4, Vimentin, Vimentin25, HSL, ALDOC, ALDOA, TUBB5, ANXA2, HADH, ACAA2 and ACADS

  88. change in protein concentration of metabolic parameters in relation to weight regain during follow-up

    Time frame: at baseline, at 5, 9, 12, 16, 46 and 53 weeks

    In LCD-group and VLCD-group

    Protein concentrations of metabolic parameters, including:

    CD36, FABP4, Vimentin, Vimentin25, HSL, ALDOC, ALDOA, TUBB5, ANXA2, HADH, ACAA2 and ACADS

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Acronym: ADIPOSTRESS

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 21, 2012
Registry last updated
Dec 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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