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Completed

NCT Number: NCT02931630

The Effect of Whey Protein and Dietary Fibers on Risk Markers of the Metabolic Syndrome and Bone Health

The prevalence of overweight and lifestyle related diseases such as cardiovascular disease (CVD) and type 2 diabetes (T2D) is increasing world wide. The metabolic syndrome (MeS) is a condition characterized by abdominal obesity, high blood lipids, high blood pressure and elevated blood sugar. MeS is associated with an increased risk of developing CVD and T2D. Dietary fibers and whey protein have independently shown beneficial effects on several of these risk factors in previous studies. Whey protein is furthermore seen to show positive effects on bone turnover.

The purpose of this trial is to investigate whether an increased intake of dietary fibers and whey protein (separately or combined) over a period of 12 weeks will affect the risk markers of MeS and bone turnover in abdominally obese subjects.

A total of 80 people with abdominal obesity will be included. The design is a randomized, double blinded, controlled dietary intervention trial. Subjects are assigned to one of four experimental groups. Each group are provided with test products containing either high or low whey protein and high or low dietary fibers to replace part of their regular diet. The subjects are instructed in how to incorporate the test products in their habitual diets in order to maintain weight stability.

The primary outcome is postprandial lipaemia (PPL) - an independent risk factor of developing CVD. PPL is estimated by performing a standardized high fat meal test during which postprandial level of triglycerides is measured. The authors hypothesize that a diet of high content of whey protein and high dietary fiber during 12 weeks will induce a reduction in PPL.

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Key information

Conditions

Abdominal Obesity Body Weight Cardiovascular Disease Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Abdominal Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Type 2 Diabetes

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital, Dep. of clinical nutrition research

Aarhus, 8000, Denmark

About this study

Please refer to summary

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Waist circumference ≥ 80 cm (women)/94 cm (men)
  • Age ≥40 years

Exclusion criteria

  • Significant cardiovascular, renal or endocrine disease
  • History of diabetes
  • ≥ 3 kg of weight gain or loss within the last 3 months
  • Any change in medication within the last month
  • Treatment with steroids
  • Pregnancy, breastfeeding or planned pregnancy
  • Psychiatric history
  • Alcohol or drug addiction
  • Dietary fiber supplement within the last month

Treatment and study plan

Whey protein powder

Other

60 g of whey protein powder

Maltodextrin powder

Other

60 g of Maltodextrin powder

High fiber bread

Other

Wheat bread with high content of dietary fibers (approximately 30 g fibers/day)

Low fiber bread

Other

Wheat bread with low content of dietary fibers (approximately 10 g fibers/day)

Primary outcomes

  1. Postprandial triglyceride response

    Time frame: Meal test: -15, 0, 60, 90, 120, 240, 360 min. Performed at baseline and at 12 weeks.

    Postprandial triglyceride response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360 min) following a high-fat meal.

Secondary outcomes

  1. 24 hours blood pressure (BP)

    Time frame: Performed at baseline and week 12

    Arteriograph 24, TensioMed, Hungary

  2. 24 hours augmentation Index (AI)

    Time frame: Performed at baseline and week 12

    Arteriograph 24, TensioMed, Hungary

  3. Respiratory Exchange Ratio

    Time frame: Meal test: -30 and 140 min. Performed at baseline and week 12.

    Measured twice during each meal test by indirect calorimetry (hood)

  4. Body composition

    Time frame: Performed at baseline and week 12

    Dual Energy X-ray Absorptiometry (DEXA) scan: Total body fat percentage, lean mass percentage, gynoid and android fat percentage

  5. Postprandial apolipoprotein B48 response

    Time frame: Meal test: -15, 0, 60, 240, 360 min. Performed at baseline and at 12 weeks.

    Postprandial apolipoprotein response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360 min) following a high-fat meal.

  6. Glucose response during high-fat meal test

    Time frame: Meal test: -15, -10, 0, 15, 30, 60, 90, 120, 240, 360 min. Performed at baseline and week 12

    Glucose response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360 min) following a high-fat meal.

  7. Insulin response during high-fat meal test

    Time frame: Meal test: -15, -10, 0, 15, 30, 60, 90, 120, 240, 360 min. Performed at baseline and week 12

    Insulin response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360 min) following a high-fat meal.

  8. Glucagon response during high-fat meal test

    Time frame: Meal test: -15, -10, 0, 15, 30, 60, 90, 120, 240, 360 min. Performed at baseline and week 12

    Glukagon response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360 min) following a high-fat meal.

  9. Glucagon-like peptide 1 (GLP-1) response during high-fat meal test

    Time frame: Meal test: -15, -10, 0, 15, 30, 60, 90, 120, 240, 360 min. Performed at baseline and week 12

    GLP-1 response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360

  10. Glucagon-like peptide 2 (GLP-2) response during high-fat meal test

    Time frame: Meal test: -15, -10, 0, 15, 30, 60, 90, 120, 240, 360 min. Performed at baseline and week 12

    GLP-2 response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360

  11. Glucose-dependent insulinotropic polypeptide (GIP) response during high-fat meal test

    Time frame: Meal test: -15, -10, 0, 15, 30, 60, 90, 120, 240, 360 min. Performed at baseline and week 12

    GIP response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360

  12. Ghrelin response during high-fat meal test

    Time frame: Meal test: -15, -10, 0, 15, 30, 60, 90, 120, 240, 360 min. Performed at baseline and week 12

    Ghrelin response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360

  13. Peptide tyrosine tyrosine (PYY) response during high-fat meal test

    Time frame: Meal test: -15, -10, 0, 15, 30, 60, 90, 120, 240, 360 min. Performed at baseline and week 12

    PYY response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360

  14. Adiponectin response during high-fat meal test

    Time frame: Meal test: -15, 0, 15, 30, 60, 90, 120, 240, 360 min. Performed at baseline and week 12

    Adiponectin response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360)

  15. Non-esterified fatty acids (NEFA) response during high-fat meal test

    Time frame: Meal test: -15, 0, 60, 90, 120, 240, 360 min. Performed at baseline and week 12

    NEFA response measured as fasting value and incremental Area Under the Curve (iAUC from -15 - 360)

  16. Interleukin-6 (IL-6) response during high-fat meal test

    Time frame: Meal test: 0, 15, 30, 60, 90, 120, 240 min. Performed at baseline and week 12

    IL-6 response measured as fasting value and incremental Area Under the Curve (iAUC from 0-240 min)

  17. Monocyte chemoattractant protein 1 (MCP-1) response during high-fat meal test

    Time frame: Meal test: 0, 15, 30, 60, 90, 120, 240 min. Performed at baseline and week 12

    MCP-1 response measured as fasting value and incremental Area Under the Curve (iAUC from 0 - 240 min)

  18. RANTES (CCL5) response during high-fat meal test

    Time frame: Meal test: 0, 15, 30, 60, 90, 120, 240 min. Performed at baseline and week 12

    CCL5 response measured as fasting value and incremental Area Under the Curve (iAUC from 0-240 min)

  19. High-sensitive c-reactive protein (hs-CRP) response during high-fat meal test

    Time frame: Meal test: 0, 15, 30, 60, 90, 120, 240 min. Performed at baseline and week 12

    hs-CRP response measured as fasting value and incremental Area Under the Curve (iAUC from 0-240 min)

  20. Procollagen type 1 N-terminal propeptide (P1NP) response during high-fat meal test

    Time frame: Meal test: 0, 15, 30, 60, 90, 120, 240 min. Performed at baseline and week 12

    P1NP response measured as fasting value and incremental Area Under the Curve (iAUC from 0-240 min)

  21. C-telopeptide (CTX) response during high-fat meal test

    Time frame: Meal test: 0, 15, 30, 60, 90, 120, 240 min. Performed at baseline and week 12

    CTX response measured as fasting value and incremental Area Under the Curve (iAUC from 0-240 min)

  22. Parathyroid hormone (PTH) response during high-fat meal test

    Time frame: Meal test: 0, 15, 30, 90, 240 min. Performed at baseline and week 12

    PTH response measured as fasting value and incremental Area Under the Curve (iAUC from 0-240 min)

  23. Osteoprotegrin response during high-fat meal test

    Time frame: Meal test: 0, 15, 30, 90, 240 min. Performed at baseline and week 12

    Osteoprotegrin response measured as fasting value and incremental Area Under the Curve (iAUC from 0-240 min)

  24. Osteocalcin response during high-fat meal test

    Time frame: Meal test: 0, 15, 30, 90, 240 min. Performed at baseline and week 12

    Osteocalcin response measured as fasting value and incremental Area Under the Curve (iAUC from 0-240 min)

  25. 25-dihydroxy vitamin D

    Time frame: Change from week 0 to week 12

    Fasting value measured at baseline and week 12

  26. Phosphate

    Time frame: Change from week 0 to week 12

    Fasting value measured at baseline and week 12

  27. Magnesium

    Time frame: Change from week 0 to week 12

    Fasting value measured at baseline and week 12

  28. Total cholesterol

    Time frame: Change from week 0 to week 12

    Fasting value measured at baseline and week 12

  29. Low density lipoprotein (LDL)

    Time frame: Change from week 0 to week 12

    Fasting value measured at baseline and week 12

  30. High density lipoprotein (HDL)

    Time frame: Change from week 0 to week 12

    Fasting value measured at baseline and week 12

  31. Glucose response during oral glucose tolerance test (OGTT)

    Time frame: OGTT: -15, -10, 0, 30, 60, 90, 120 min. Performed at baseline and week 12

    Glucose measured as incremental Area Under the Curve (iAUC from -15 - 120 min)

  32. Insulin response during oral glucose tolerance test (OGTT)

    Time frame: OGTT: -15, -10, 0, 30, 60, 90, 120 min. Performed at baseline and week 12

    Insulin measured as incremental Area Under the Curve (iAUC from -15 - 120 min)

  33. Glucagon response during oral glucose tolerance test (OGTT)

    Time frame: OGTT: -15, -10, 0, 30, 60, 90, 120 min. Performed at baseline and week 12

    Glucagon measured as incremental Area Under the Curve (iAUC from -15 - 120 min)

  34. Glucagon-like peptide 1 (GLP-1) response during oral glucose tolerance test (OGTT)

    Time frame: OGTT: -15, -10, 0, 30, 60, 90, 120 min. Performed at baseline and week 12

    GLP-1 measured as incremental Area Under the Curve (iAUC from -15 - 120 min)

  35. Glucagon-like peptide 2 (GLP-2) response during oral glucose tolerance test (OGTT)

    Time frame: OGTT: -15, -10, 0, 30, 60, 90, 120 min. Performed at baseline and week 12

    GLP-2 measured as incremental Area Under the Curve (iAUC from -15 - 120 min)

  36. Glucose-dependent insulinotropic polypeptide (GIP) response during oral glucose tolerance test (OGTT)

    Time frame: OGTT: -15, -10, 0, 30, 60, 90, 120 min. Performed at baseline and week 12

    GIP measured as incremental Area Under the Curve (iAUC from -15 - 120 min)

  37. Parathyroid hormone (PTH) response during oral glucose tolerance test (OGTT)

    Time frame: OGTT: 0, 30, 90 min. Performed at baseline and week 12

    PTH measured as incremental Area Under the Curve (iAUC from 0-90 min)

  38. C-telopeptide (CTX) response during oral glucose tolerance test (OGTT)

    Time frame: OGTT: 0, 30, 90 min. Performed at baseline and week 12

    CTX measured as incremental Area Under the Curve (iAUC from 0-90 min)

  39. Procollagen type 1 N-terminal propeptide (P1NP) response during oral glucose tolerance test (OGTT)

    Time frame: OGTT: 0, 30, 90 min. Performed at baseline and week 12

    P1NP measured as incremental Area Under the Curve (iAUC from 0-90 min)

  40. Osteoprotegrin response during oral glucose tolerance test (OGTT)

    Time frame: OGTT: 0, 30, 90 min. Performed at baseline and week 12

    Osteoprotegrin measured as incremental Area Under the Curve (iAUC from 0-90 min)

  41. Osteocalcin response during oral glucose tolerance test (OGTT)

    Time frame: OGTT: 0, 30, 90 min. Performed at baseline and week 12

    Osteocalcin measured as incremental Area Under the Curve (iAUC from 0-90 min)

  42. Waist and hip circumference.

    Time frame: Change from week 0 to week 12

    Waist and hip circumference in cm

  43. Body weight

    Time frame: Change from week 0 to week 12

    Body weight in kg

  44. Body Mass Index

    Time frame: Change from week 0 to week 12

    kg/m2

  45. Adipose tissue gene expression

    Time frame: Change from week 0 to week 12

    Subcutaneous fat tissue biopsy performed at baseline and week 12 for the measurement of changes in genes related to lipid and glucose metabolism and insulin signalling.

  46. Adipose tissue proliferation and differentiation

    Time frame: Change from week 0 to week 12

    Subcutaneous fat tissue biopsy performed at baseline and week 12 for measuring proliferation and differentiation processes of preadipocyte stem cells into mature adipocytes, and to test the effect of diets on expanding the capacity of the subcutaneous adipose tissue to store fat.

  47. Urinary calcium

    Time frame: Change from week 0 to week 12

    Urinary calcium excretion measured in 24-hour urine samples collected at baseline and week 12

  48. Urinary nitrogen

    Time frame: Change from week 0 to week 12

    Urinary nitrogen excretion measured in 24-hour urine samples collected at baseline and week 12

  49. Metabolomics, plasma

    Time frame: OGTT: -15, 30, 60, 90, 120 min. Performed at baseline and week 12.

    Non-targeted metabolomics analysis using Liquid Chromatography - Mass Spectrometry

  50. Metabolomics, urine

    Time frame: 24-hour urine collection performed at baseline and week 12.

    Non-targeted metabolomics analysis using Liquid Chromatography - Mass Spectrometry

  51. Metabolomics, faeces

    Time frame: Collected at baseline and week 12.

    Non-targeted metabolomics analysis using Liquid Chromatography - Mass Spectrometry

  52. Insulin sensitivity during oral glucose tolerance test (OGTT)

    Time frame: OGTT performed at baseline and week 12 (blood sampling at -15, -10, 0, 30, 60, 90, 120 min)

    Homeostasis model assessment - insulin resistance (HOMA-IR) and Matsuda Index calculated based on blood glucose and insulin measurements during OGTT

  53. Appetite assessment during high-fat meal test

    Time frame: Meal test: Questionnaire at -10, 0, 30, 60, 90, 120, 180, 240, 300, 360 min. Performed at baseline and week 12.

    Visual Analog Scale (VAS) electronic questionnaire

  54. Microbiota

    Time frame: Faecal samples collected at baseline and week 12.

    Non-targeted microbiome and metabolome analyses using high-throughput DNA sequencing on Illumina Miseq and Liquid Chromatography - Mass Spectrometry (LC-MS) metabolomics,

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Collaborators

  • Rigshospitalet, Denmark
  • University of Aarhus
  • University of California, Davis
  • University of Copenhagen

Registry information

Acronym: MERITS

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 13, 2016
Registry last updated
Jul 17, 2017

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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