Overview

This trial is active, not recruiting.

Condition prevention of obesity
Treatments whey protein, whey protein enriched with calcium, soy protein, maltodextrin
Sponsor University of Copenhagen
Collaborator Arla Foods
Start date January 2012
End date January 2015
Trial size 200 participants
Trial identifier NCT01561131, B288

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose prevention
Arm
(Active Comparator)
Whey protein
whey protein
45g protein/d; Dosage 3x15g protein daily
(Active Comparator)
Whey protein enriched with calcium
whey protein enriched with calcium
45g protein/d + 1000mg calcium/d; dosage: 15g protein + 333mg calcium x 3 daily
(Active Comparator)
Soy protein
soy protein
45g soy protein/d; dosage 15g soy protein x 3 daily
(Placebo Comparator)
Maltodextrin
maltodextrin
48g carbohydrate/d; dosage: 16g carbohydrate x 3 daily

Primary Outcomes

Measure
Difference in body weight and composition during the weight maintenance period
time frame: 24 weeks

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Official title The Effect of Protein and Calcium on Weight Change and Blood Lipid Profile
Principal investigator Arne Astrup, Prof., MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by University of Copenhagen.