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

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

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

Sponsors & Collaborators

• Arla Foods

  collaborator INDUSTRY

• Nupo A/S, Denmark

  collaborator UNKNOWN

• University of Copenhagen

  lead OTHER

Principal Investigators

• Arne Astrup, Prof., MD · Department of Human Nutrition, University of Copenhagen

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-01-31

Primary Completion

2014-12-31

Completion

2015-01-31

Countries

• Denmark