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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01561131
Recruitment Status : Completed
First Posted : March 22, 2012
Last Update Posted : February 7, 2017
Sponsor:
Collaborators:
Arla Foods
Nupo A/S, Denmark
Information provided by (Responsible Party):
Arne Astrup, University of Copenhagen

Tracking Information
First Submitted Date  ICMJE March 20, 2012
First Posted Date  ICMJE March 22, 2012
Last Update Posted Date February 7, 2017
Actual Study Start Date  ICMJE January 2012
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2012)
Difference in body weight and composition during the weight maintenance period [ Time Frame: 24 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01561131 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2012)
  • Difference in fasting blood lipid profile during the weight maintenance period. [ Time Frame: 24 weeks ]
  • 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 ]
  • Difference in resting blood pressure and pulse during the weight maintenance period. [ Time Frame: 24 weeks ]
  • Difference in intestinal flora during the weight maintenance period. [ Time Frame: 24 weeks ]
  • Nutrigenomics (NMR) analysis. [ Time Frame: 24 weeks ]
  • Difference in energy intake (EI) and macronutrient intake from the diet during the weight maintenance period. [ Time Frame: 24 weeks ]
  • Difference in acute- and long-term effet on diet induced thermogenesis and substrate oxidation. [ Time Frame: 24 weeks. ]
  • Difference in acute- and long-term effect on postprandial appetite regulation (measured via VAS, appetite regulating hormones and energy intake) [ Time Frame: 24 weeks ]
  • Difference in acute- and long-term effect on postprandial response in insulin, glucose, C-peptide, and glucagon. [ Time Frame: 24 weeks ]
  • 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 ]
  • Change in body weight and composition during the weight loss period [ Time Frame: 8 weeks ]
  • Change in blood lipid profile during the weight loss period [ Time Frame: 8 weeks ]
  • Change in fasting insulin, glucose ect. during the weight loss period [ Time Frame: 8 weeks ]
  • Change in intestinal flora during the weight loss period. [ Time Frame: 8 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Protein and Calcium on Weight Change and Blood Lipid Profile
Official Title  ICMJE The Effect of Protein and Calcium on Weight Change and Blood Lipid Profile
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Prevention of Obesity
Intervention  ICMJE
  • Dietary Supplement: Whey protein
    45g protein/d; Dosage 3x15g protein daily
  • Dietary Supplement: Whey protein enriched with calcium
    45g protein/d + 1000mg calcium/d; dosage: 15g protein + 333mg calcium x 3 daily
  • Dietary Supplement: Soy protein
    45g soy protein/d; dosage 15g soy protein x 3 daily
  • Dietary Supplement: Maltodextrin
    48g carbohydrate/d; dosage: 16g carbohydrate x 3 daily
Study Arms  ICMJE
  • Active Comparator: Whey protein supplement
    Whey protein
    Intervention: Dietary Supplement: Whey protein
  • Active Comparator: Whey protein enriched with calcium supplement
    Whey protein enriched with calcium
    Intervention: Dietary Supplement: Whey protein enriched with calcium
  • Active Comparator: Soy protein supplement
    Soy protein
    Intervention: Dietary Supplement: Soy protein
  • Placebo Comparator: Control supplement
    Maltodextrin
    Intervention: Dietary Supplement: Maltodextrin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 6, 2017)
223
Original Estimated Enrollment  ICMJE
 (submitted: March 20, 2012)
200
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01561131
Other Study ID Numbers  ICMJE B288
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Arne Astrup, University of Copenhagen
Study Sponsor  ICMJE University of Copenhagen
Collaborators  ICMJE
  • Arla Foods
  • Nupo A/S, Denmark
Investigators  ICMJE
Principal Investigator: Arne Astrup, Prof., MD Department of Human Nutrition, University of Copenhagen
PRS Account University of Copenhagen
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP