NCT04156165: BEEF

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

Completed NA Last updated 1 November 2021

What this trial tests

NA trial testing VLCD-Active in Weight Loss in 110 participants. Completed in 31 December 2020.

Timeline

1 November 2019

Primary endpoint
10 November 2020

31 December 2020

Quick facts

Lead sponsor	University of Copenhagen
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	double
Primary purpose	treatment
Enrollment	110
Start date	1 November 2019
Primary completion	10 November 2020
Estimated completion	31 December 2020
Sites	1 location across Denmark

Drugs / interventions tested

• VLCD-Active
• Maintenance-Active
• VLCD-Control
• Maintenance-Control

Conditions studied

• Weight Loss — all drugs for Weight Loss →
• Metabolism and Nutrition Disorder — all drugs for Metabolism and Nutrition Disorder →
• Obesity — all drugs for Obesity →

Sponsor

University of Copenhagen

Who can join

Adults 18 to 65, any sex, with Weight Loss or Metabolism and Nutrition Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. A protein-supplemented very-low-calorie diet does not mitigate reductions in lean mass and resting metabolic rate in subjects with overweight or obesity: A randomized controlled trial.
   Magkos F, Hjorth MF, Asping S, Rosenkrans MI, et al · · 2021 · cited 10× · PMID 34749132 · DOI 10.1016/j.clnu.2021.10.006
2. Unprocessed red meat in the dietary treatment of obesity: a randomized controlled trial of beef supplementation during weight maintenance after successful weight loss.
   Magkos F, Rasmussen SI, Hjorth MF, Asping S, et al · · 2022 · cited 5× · PMID 36307956 · DOI 10.1093/ajcn/nqac152