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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Weight Loss; Metabolism and Nutrition Disorder
• Intervention / Treatment: Dietary supplement: VLCD-Control; Dietary supplement: VLCD-Active; Other: Maintenance-Control; Other: Maintenance-Active

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • DK
    • Frederiksberg, DK, Denmark, 1958
      • University of Copenhagen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: VLCD-Control; Very low calorie diet, 600 kcal pr day for eight weeks.	Dietary supplement: VLCD-Control; Lighter life VLCD products; Other Names: Moderat protein VLCD
Experimental: VLCD-Active; Very low calorie diet plus additional 25 g protein powder, 700 kcal pr day for eight weeks.	Dietary supplement: VLCD-Active; Lighter life formula products supplied to subjects, four sachets pr day. Dietetic advise given regularly.; Other Names: High protein VLCD
Active Comparator: Maintenance-Control; 12-week weight maintenance diets: Moderate protein weight maintenance diet (MP-WMD): Recommended healthy diet including 25 g beef daily. The diet is ad libitum and will be high in fibre (40 g/10 MJ) and whole grain (150 g/day) and allow inclusion of free/added sugar up to the recommended level (<10E% sugar).	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.; Other Names: Moderate protein diet
Experimental: Maintenance-Active; 12-week weight maintenance diets: High protein weight maintenance diet (HP-WMD): The macronutrient distribution will be 25 energy percentage (E%) from protein, 45 E% from carbohydrate and 30 E% from fat. The diet will include 150 g beef as a daily source of protein, The diet is ad libitum and will be high in fibre (40 g/10 MJ) and whole grain (150 g/day) and allow inclusion of free/added sugar up to the recommended level (<10E% sugar).	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.; Other Names: High protein diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	The subjects will be instructed to stand in the middle of the platform of the scale with a straight neck and eyes looking straight ahead, whilst distributing their weight evenly on both feet. Two measurements are made when the scale has stabilized and both results are noted to the nearest 0.1 kg. The average of the two measurements is used in further analysis.	up to week 21

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body composition	Body composition will be assessed by DXA as whole body scan	up to week 21
Glucose metabolism	Measurements of fasting glucose, insulin, HbA1c	up to week 21
Inflammation	Measurements of fasting CRP, plasma lipids	Up to week 21
Fecal samples	Measurement of microbiota (bacteria strains present in feces) and metabolomics markers	Up to week 21
Resting metabolic rate	Resting metabolic rate will be measured by indirect calorimetry, using a ventilated hood system as described by the manufacture	Up to week 21
Endocrine disruptors	Measurement of fasting T3 and T4	Up to week 21
Height	The participant will be instructed to remove shoes and asked to stand erect with their back to the wall-mounted stadiometer, with the back of their head, back, and buttocks touching the stadiometer. The participant will be further instructed to look straight ahead and keep arms relaxed and hanging loosely alongside their body and to inhale deeply. The reading on the stadiometer will be performed before the participant exhales. Two measurements are made and both results are recorded in centimeters to the nearest 0.5 of a centimeter. The average of the two measurements is used in further analysis.	Week 0
Waist circumference	The measurement of waist circumference will be performed in a fasting condition with an empty bladder. The measure is done with a with a no-elastic tape measure mid-way between the lower rib and iliac crest (top of the hip bone) at the end of expiration with the participant in a standing position with their weight distributed evenly on both feet. Two measurements are made and both results are noted to the nearest 0.5 cm and the average of the two measurements is used in further analysis.	Up to week 21
Hip circumference	The measurement of hip circumference will be measured in a fasting condition with an empty bladder. The measure is done with a tape measure at the widest point between the hips and buttocks observed from the front at the end of expiration with the participant in a standing position with their weight distributed evenly on both feet. Two measurements are made and both results are noted to the nearest 0.5 cm and the average of the two measurements is used in further analysis.	Up to week 21
Blood pressure	Systolic and diastolic blood pressure will be measured using a validated automatic device with an appropriate arm cuff after 5-10 min rest in a resting position	Up to week 21

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Initial glucose metabolism	To investigate the effect of initial glucose metabolism on the response to high vs. moderate protein diet on weight maintenance.	Up to week 21
Initial microbiota	Statistical investigation of the effect of initial microbiota assessed by fecal sample on weight change	Up to week 21
Initial body composition	Statistical investigation of the effect of initial body composition assessed by DXA scan on weight change.	Up to week 21
Physical activity and sleep	Physical activity and sleep patterns will be measured by an accelerometer (ActiGraph GT3X+) in the 7 days/8 nights	Up to week 21
Perceived stress	Assessed by Perceived Stress Scale questionnaire	Up to week 21
Life quality	Assessed by SF-36 questionnaire	Up to week 21

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: US National Cattlemen´s Association; Danish Agriculture and Food Counsel
• Investigators: Principal Investigator: Arne Astrup, Professor, Department of Nutrition, Exercise and Sports, UCPH

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): November 10, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: November 1, 2019
• First Submitted That Met QC Criteria: November 5, 2019
• First Posted (Actual): November 7, 2019

Study Record Updates

• Last Update Posted (Actual): November 1, 2021
• Last Update Submitted That Met QC Criteria: October 25, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Body composition; Metabolism
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss; Nutrition Disorders
• Other Study ID Numbers: B-352; H-19041921 (Registry Identifier: Danish Ethical Committee)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No