Clinical trial NCT04156165: The Effect of High vs. Moderate Protein Consumption on Human Health
Official title: BEEF The Effect of High vs. Moderate Protein Consumption on Human Health - With Beef as Major Source of Protein
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Metabolism and Nutrition Disorder
Obesity
Keywords: Body composition
Metabolism
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: US National Cattlemen´s Association
name: Danish Agriculture and Food Counsel
First posted: 2019-11-07
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2x2 factorial intervention trial with two and two arms
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Healthy men or women
* Age, 18-65 years
* Overweight or grade I-II obesity (BMI 28-40.0 kg/m2)
* Provided voluntary written informed consent

Exclusion Criteria (main:

* Weight changes ± 5% in the last three months
* Vegetarian, vegan
* Pregnancy or lactation, pregnancy within the past 12 month or plans to become pregnant during the study
* History or diagnosis of diabetes
* History or diagnosis of heart, liver or kidney disease
* History or diagnosis of eating disorders
* Chronic diseases e.g. cancer within the past 5 years (except adequately-treated localized basal cell skin cancer)
* Simultaneous blood donation for other purpose than this study
* Simultaneous participation in other clinical intervention studies
* Use of drugs, that in the opinion of the medically responsible investigator, are likely to affect the outcomes of the study
* Any other condition that judged by the investigator may interfere with the adherence to the study protocol

Primary outcomes:
measure: Body weight
timeFrame: up to week 21
Secondary outcomes:
measure: Body composition
timeFrame: up to week 21
measure: Glucose metabolism
timeFrame: up to week 21
measure: Inflammation
timeFrame: Up to week 21
measure: Fecal samples
timeFrame: Up to week 21
measure: Resting metabolic rate
timeFrame: Up to week 21
measure: Endocrine disruptors
timeFrame: Up to week 21
measure: Height
timeFrame: Week 0
measure: Waist circumference
timeFrame: Up to week 21
measure: Hip circumference
timeFrame: Up to week 21
measure: Blood pressure
timeFrame: Up to week 21
Other outcomes:
measure: Initial glucose metabolism
timeFrame: Up to week 21
measure: Initial microbiota
timeFrame: Up to week 21
measure: Initial body composition
timeFrame: Up to week 21
measure: Physical activity and sleep
timeFrame: Up to week 21
measure: Perceived stress
timeFrame: Up to week 21
measure: Life quality
timeFrame: Up to week 21
Locations:
city: Frederiksberg
country: Denmark
facility: University of Copenhagen
state: DK
Study officials:
affiliation: Department of Nutrition, Exercise and Sports, UCPH
name: Arne Astrup, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Magkos F, Hjorth MF, Asping S, Rosenkrans MI, Rasmussen SI, Ritz C, Sjodin A, Geiker NRW. 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. Clin Nutr. 2021 Dec;40(12):5726-5733. doi: 10.1016/j.clnu.2021.10.006. Epub 2021 Oct 18.