Study title
The Effect of Protein and Calcium on Weight Change and Blood Lipid Profile
Template
Intervention/Observation study
title
The Effect of Protein and Calcium on Weight Change and Blood Lipid Profile
description
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.
startDate
2012-01-01 00:00:00.0
Study type
Human Intervention
Principle Investigator
Arne Astrup
Primary endpoint
Weight maintenance (no body weight increase)
Objectives
Investigation the effect of protein supplements from either whey with or without calcium or soy on WM success after WL compared with that of a control.
Central conclusion
Protein supplementation does not result in improved
WM success, or blood biochemistry after WL compared with the
effects of normal dietary protein intake (0.8–1.0 g $ kg21 $ d21)
Main health-related outcome
Neither soy nor whey protein improves weight loss beyond nomal dietary protein intakes
Exclusion criteria
Age outside 18-60y
Intolerance to soy or whey
pregnancy or lactation
Recent blood donation (<6mo)
Inclusion criteria
BMI>27
signed informed consent
Institute
Nutrition, Exercise and Sports, University of Copenhagen
Collaborators involved
The Novo Nordisk Foundation Center for Basic Metabolic Research, Section of Metabolic Genetics, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark; Global Nutrition and Clinicals, Arla Foods amba, Brabrand, Denmark
Funding body
Arla Foods, Viby J, Denmark, Arla Foods Ingredients Group P/S, Viby J, Denmark, and the Faculty of Science, University of Copenhagen
Clinicaltrials.gov or similar number
NCT01561131
Was the study approved by an ethics committee?
Yes
Ethical approval number
H-2-2011- 145
Did the individuals providing data sign informed consent?
Yes
Description of "Start groups"
Groups with different supplements, whey protein (45g/d), whey protein (45g/d + 1000mg Ca/d), soy protein (45g/d), control (maltodextrin, 48g/d).
Type of controls
isocaloric carbohydrate supplement
Full randomisation method (if any)
Computer random number generator
Blinding method
powders delivered by third party
Compliance assessment (for each treatment)
Compliance with supplement intake was evaluated via an
analysis of nitrogen excretion by 24-h urine collection at
baseline and 2 times during the WM period (weeks 14 and 32)
Total number of arms (Give number of distinct treatments in study)
4
Explanatory text (Give a textual account of the overall design leading to the total number of groups) or provide the study protocol.
After a common 8w weight loss period, volunteers were randomised to the four arms with different supplements (parallel study) for an additional 16 weeks.
Treatments (Number and types of foods, drugs or other treatments compared)
1. whey protein, 45g/d
2. whey protein, 45g/d + 1000mg Ca/d
3 soy protein, 45g/d
4 maltodextrin, 48g/d
Number of volunteers screened N(M:xx, F: xx)
220
Number of volunteers enrolled N(M:xx, F: xx)
219 (M:48, F:171)
Number of subjects (Male; Female)
48; 171
Start of recruitment (Start year or date)
2012-01-01 00:00:00.0
End of recruitment (End year or date)
2014-01-01 00:00:00.0
