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Clinical Trial 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.


Clinical Trial Description

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Study Design


Related Conditions & MeSH terms


NCT number NCT01561131
Study type Interventional
Source University of Copenhagen
Contact
Status Completed
Phase N/A
Start date January 2012
Completion date January 2015