The Effect of High vs. Moderate Protein Consumption on Human Health

Summary

The study will be conducted as a parallel randomized controlled intervention trial, initiated by eight weeks rapid weight loss with one of two VLCDs, one week of reintroducing regular foods, and 12 weeks with one of two different ad libitum diets; in total 21 weeks. The study will be blinded for the statistician. Due to obvious different dietary intakes in the two diets, subjects cannot be blinded and neither the study personnel. As the study includes different dietary recommendations the registered clinical dietician advising the subjects cannot be blinded either.

In total 110 overweight and obese volunteers will be included.

Conditions

• Weight Loss
• Metabolism and Nutrition Disorder
• Obesity

Interventions

DIETARY_SUPPLEMENT

VLCD-Active

Lighter life formula products supplied to subjects, four sachets pr day. Dietetic advise given regularly.

OTHER

Maintenance-Active

Weight loss maintenance diet with high protein and low glycemic index and load, high in fiber and whole grain, daily including 150 g minced beef.

DIETARY_SUPPLEMENT

VLCD-Control

Lighter life VLCD products

OTHER

Maintenance-Control

Weight loss maintenance diet with moderate protein and low glycemic index and load, high in fiber and whole grain, daily including 25 g minced beef.

Sponsors & Collaborators

• US National Cattlemen´s Association

  collaborator UNKNOWN

• Danish Agriculture and Food Counsel

  collaborator UNKNOWN

• University of Copenhagen

  lead OTHER

Principal Investigators

• Arne Astrup, Professor · Department of Nutrition, Exercise and Sports, UCPH

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-11-01

Primary Completion

2020-11-10

Completion

2020-12-31

Countries

• Denmark

Study Locations