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Completed

NCT Number: NCT01561131

The Effect of Protein and Calcium on Weight Change and Blood Lipid Profile

The primary aim is to examine the effect of a high protein intake (from soy or whey protein) on weightmaintenance after weight loss in a group of predisposed (severe) obese persons. Furthermore, to examine short-term and long-term effect of a high protein intake on appetite regulation and diet induced thermogenese (DIT). Finally to examine the effect of calcium on weightmaintence, bloodlipid profilen, appetite regulation and DIT.

The study is a parallel RCT with a weight loss (WL) period (8 weeks on very low calorie diet) and a weightmaintence (WM) period (24 weeks daily intake of supplement). 200 overweight/obese subjects will be enrolled into the study and randomized to placebo (maltodextrin), soy protein, whey protein or calcium enriched whey protein supplement. At baseline (week 0), after the WL period (week 8) and after WM period (week 24) body weight and composition will be measured and blood samples will be collected. Meal test will be performed at week 0 and 24 (examining both appetite regulation and DIT). Urine and feces will be collected three times during the study. Subjects will receive dietary counseling (in groups) regularly during the study and body weight will be measured at each visit.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Human Nutrition, University of Copenhagen

Frederiksberg, Copenhagen, 1958, Denmark

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Both men and women can be included
  • All ethnic groups can be included
  • Age: 18≤age≤60
  • BMI: 28≤BMI≤40

Exclusion criteria

  • smoking
  • use of cholesterol-lowering medications or other medications considered to be of importance for participation in the trial
  • use of special diets (eg. Atkins, vegetarian) within 2 months before the start of the project.
  • elite athletes or if subjecct is planning to become elite athlete (e.g. Planning major changes in physical activity during the experiment).
  • blood donation within the last 3 months before the commencement of the trial
  • weight change> 3 kg within 2 months before the start of the project
  • sagital height of 32 cm
  • pregnant or nursing women or women planning to become pregnant within the next 12 months.
  • surgically treated obesity
  • participation in other clinical trials within the last 3 months
  • if consuming medicine daily, consumption of prescription medicine needs to have been stable through at least the last 3 months and is expected to remain so throughout the whole study. However, a subject cannot be included if the treatment includes medicine that is a systemic treatment that is considered to be of importance for participation in the project.
  • alcohol or drug use (based on clinical judgment)
  • subjects who are unable to give an informed consent.
  • chronic systemic infectious or inflammatory disorders
  • chronic endocrine disorders
  • inadequate nutrient uptake, or chronic gastrointestinal or liver diseases (apart from irritable bowel disorder)
  • cardiovascular disease, recognized heart failure or brain disease
  • cancer within the past 10 years
  • subject who is judged unable to participate in an LCD (low calorie diet) in an 8 week period
  • known allergy to para-aminobenzoic acid (PABA)
  • subjects who are in a general physical and/or mental condition,where the researcher assesses that the subject does not conform with the general aim of the study.
  • subjects with a hemoglobin value below 7 mol / L. Those with a hemoglobin value below 8 mol / L (measured at screening) cannot volunteer for the meal test during hood measurements, but may be included in the main study.

When starting on a weight maintenance period:

  • persons during weight loss period, loss of <8% of their initial body weight

Treatment and study plan

Whey Protein

Dietary Supplement

45g protein/d; Dosage 3x15g protein daily

Whey protein enriched with calcium

Dietary Supplement

45g protein/d + 1000mg calcium/d; dosage: 15g protein + 333mg calcium x 3 daily

Soy protein

Dietary Supplement

45g soy protein/d; dosage 15g soy protein x 3 daily

Maltodextrin

Dietary Supplement

48g carbohydrate/d; dosage: 16g carbohydrate x 3 daily

Primary outcomes

  1. Difference in body weight and composition during the weight maintenance period

    Time frame: 24 weeks

Secondary outcomes

  1. Difference in fasting blood lipid profile during the weight maintenance period.

    Time frame: 24 weeks

  2. Difference in fasting insulin, glucose, C-peptide, glucagon, insulin-like growth factor 1 (IGF-1), ionized calcium, parathyroideahormone (PTH), and angiopoietin-like protein 4 (Angpt14) during the weight maintenance period.

    Time frame: 24 weeks

  3. Difference in resting blood pressure and pulse during the weight maintenance period.

    Time frame: 24 weeks

  4. Difference in intestinal flora during the weight maintenance period.

    Time frame: 24 weeks

  5. Nutrigenomics (NMR) analysis.

    Time frame: 24 weeks

  6. Difference in energy intake (EI) and macronutrient intake from the diet during the weight maintenance period.

    Time frame: 24 weeks

  7. Difference in acute- and long-term effet on diet induced thermogenesis and substrate oxidation.

    Time frame: 24 weeks.

  8. Difference in acute- and long-term effect on postprandial appetite regulation (measured via VAS, appetite regulating hormones and energy intake)

    Time frame: 24 weeks

  9. Difference in acute- and long-term effect on postprandial response in insulin, glucose, C-peptide, and glucagon.

    Time frame: 24 weeks

  10. Difference in appetite regulating hormones (ghrelin, glucagon-like peptide-1 (GLP-1), peptide YY (PYY), and cholecystokinin (CCK)) during weight maintenance period.

    Time frame: 24 weeks

  11. Change in body weight and composition during the weight loss period

    Time frame: 8 weeks

  12. Change in blood lipid profile during the weight loss period

    Time frame: 8 weeks

  13. Change in fasting insulin, glucose ect. during the weight loss period

    Time frame: 8 weeks

  14. Change in intestinal flora during the weight loss period.

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Arla Foods
  • Nupo A/S, Denmark

Registry information

Acronym: PROKA

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Mar 22, 2012
Registry last updated
Feb 7, 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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