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

This study is currently recruiting participants.
Verified August 2012 by University of Copenhagen
Sponsor:
Collaborators:
Arla Foods Ingredients Group P/S, Denmark
Arla Foods amba, Denmark
Nupo A/S, Denmark
Information provided by (Responsible Party):
AAstrup, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01561131
First received: March 20, 2012
Last updated: August 29, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention
Prevention of Obesity
 Dietary Supplement: Whey protein
Dietary Supplement: Whey protein enriched with calcium
Dietary Supplement: Soy protein
Dietary Supplement: Maltodextrin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Protein and Calcium on Weight Change and Blood Lipid Profile

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Difference in body weight and composition during the weight maintenance period [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference in fasting blood lipid profile during the weight maintenance period. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Difference in resting blood pressure and pulse during the weight maintenance period. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Difference in intestinal flora during the weight maintenance period. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Nutrigenomics (NMR) analysis. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Difference in energy intake (EI) and macronutrient intake from the diet during the weight maintenance period. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Difference in acute- and long-term effet on diet induced thermogenesis and substrate oxidation. [ Time Frame: 24 weeks. ] [ Designated as safety issue: No ]
  • Difference in acute- and long-term effect on postprandial appetite regulation (measured via VAS, appetite regulating hormones and energy intake) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Difference in acute- and long-term effect on postprandial response in insulin, glucose, C-peptide, and glucagon. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change in body weight and composition during the weight loss period [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change in blood lipid profile during the weight loss period [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change in fasting insulin, glucose ect. during the weight loss period [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change in intestinal flora during the weight loss period. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01561131

Contacts
Contact: Janne K Lorenzen, PhD +45 35332500 jakh@life.ku.dk
Contact: Luise E Gunvald, PhD-student +45 35332619 gunvald@life.ku.dk

Locations
Denmark
Department of Human Nutrition, University of Copenhagen Recruiting
Frederiksberg, Copenhagen, Denmark, 1958
Contact: Luise E Gunvald, PhD-student     +45 35332619     gunvald@life.ku.dk    
Principal Investigator: Arne V Astrup, Prof., MD            
Sponsors and Collaborators
University of Copenhagen
Arla Foods Ingredients Group P/S, Denmark
Arla Foods amba, Denmark
Nupo A/S, Denmark
Investigators
Principal Investigator: Arne Astrup, Prof., MD Department of Human Nutrition, University of Copenhagen
  More Information

No publications provided

Responsible Party: AAstrup, Prof., MD, Head of Department, Department of Human Nutrition, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01561131     History of Changes
Other Study ID Numbers: B288
Study First Received: March 20, 2012
Last Updated: August 29, 2012
Health Authority: Denmark: Ethics Committee

Keywords provided by University of Copenhagen:
Obesity
Protein intake
Calcium intake
Weight loss
 Weight maintenance
Blood lipid profile
Diet induced thermogenesis

Additional relevant MeSH terms:
Calcium, Dietary
Body Weight Changes
Obesity
Body Weight
Signs and Symptoms
Overnutrition
 Nutrition Disorders
Overweight
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013