NCT04156165

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

BEEF The Effect of High vs. Moderate Protein Consumption on Human Health - With Beef as Major Source of Protein

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: University of Copenhagen · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2019-11-01
• Primary completion: 2020-11-10
• Completion: 2020-12-31
• First posted: 2019-11-07
• Last updated: 2021-11-01

Locations

1 site across 1 country: Denmark