NCT01561131

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 223 (actual)
• Sponsor: University of Copenhagen · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Prevention of Obesity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Whey protein	45g protein/d; Dosage 3x15g protein daily
DIETARY_SUPPLEMENT	Whey protein enriched with calcium	45g protein/d + 1000mg calcium/d; dosage: 15g protein + 333mg calcium x 3 daily
DIETARY_SUPPLEMENT	Soy protein	45g soy protein/d; dosage 15g soy protein x 3 daily
DIETARY_SUPPLEMENT	Maltodextrin	48g carbohydrate/d; dosage: 16g carbohydrate x 3 daily

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-12-01
• Completion: 2015-01-01
• First posted: 2012-03-22
• Last updated: 2017-02-07

Locations

1 site across 1 country: Denmark