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

February 6, 2017 updated by: Arne Astrup, University of Copenhagen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

223

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Frederiksberg, Copenhagen, Denmark, 1958
        • Department of Human Nutrition, University of Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Whey protein supplement
Whey protein
Dietary supplement: Whey protein
45g protein/d; Dosage 3x15g protein daily
ACTIVE_COMPARATOR: Whey protein enriched with calcium supplement
Whey protein enriched with calcium
Dietary supplement: Whey protein enriched with calcium
45g protein/d + 1000mg calcium/d; dosage: 15g protein + 333mg calcium x 3 daily
ACTIVE_COMPARATOR: Soy protein supplement
Soy protein
Dietary supplement: Soy protein
45g soy protein/d; dosage 15g soy protein x 3 daily
PLACEBO_COMPARATOR: Control supplement
Maltodextrin
Dietary supplement: Maltodextrin
48g carbohydrate/d; dosage: 16g carbohydrate x 3 daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference in body weight and composition during the weight maintenance period
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Difference in fasting blood lipid profile during the weight maintenance period.
Time Frame: 24 weeks
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
24 weeks
Difference in resting blood pressure and pulse during the weight maintenance period.
Time Frame: 24 weeks
24 weeks
Difference in intestinal flora during the weight maintenance period.
Time Frame: 24 weeks
24 weeks
Nutrigenomics (NMR) analysis.
Time Frame: 24 weeks
24 weeks
Difference in energy intake (EI) and macronutrient intake from the diet during the weight maintenance period.
Time Frame: 24 weeks
24 weeks
Difference in acute- and long-term effet on diet induced thermogenesis and substrate oxidation.
Time Frame: 24 weeks.
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
24 weeks
Difference in acute- and long-term effect on postprandial response in insulin, glucose, C-peptide, and glucagon.
Time Frame: 24 weeks
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
24 weeks
Change in body weight and composition during the weight loss period
Time Frame: 8 weeks
8 weeks
Change in blood lipid profile during the weight loss period
Time Frame: 8 weeks
8 weeks
Change in fasting insulin, glucose ect. during the weight loss period
Time Frame: 8 weeks
8 weeks
Change in intestinal flora during the weight loss period.
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

Arla Foods
Nupo A/S, Denmark

Investigators

  • Principal Investigator: Arne Astrup, Prof., MD, Department of Human Nutrition, University of Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2012

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

January 1, 2015

Study Registration Dates

First Submitted

March 20, 2012

First Submitted That Met QC Criteria

March 20, 2012

First Posted (ESTIMATE)

March 22, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

February 7, 2017

Last Update Submitted That Met QC Criteria

February 6, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B288

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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