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

Primary Purpose

Weight Loss, Metabolism and Nutrition Disorder, Obesity

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
VLCD-Active
Maintenance-Active
VLCD-Control
Maintenance-Control
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss focused on measuring Body composition, Metabolism

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Copenhagen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

VLCD-Control

VLCD-Active

Maintenance-Control

Maintenance-Active

Arm Description

Very low calorie diet, 600 kcal pr day for eight weeks.

Very low calorie diet plus additional 25 g protein powder, 700 kcal pr day for eight weeks.

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).

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Body composition
Body composition will be assessed by DXA as whole body scan
Glucose metabolism
Measurements of fasting glucose, insulin, HbA1c
Inflammation
Measurements of fasting CRP, plasma lipids
Fecal samples
Measurement of microbiota (bacteria strains present in feces) and metabolomics markers
Resting metabolic rate
Resting metabolic rate will be measured by indirect calorimetry, using a ventilated hood system as described by the manufacture
Endocrine disruptors
Measurement of fasting T3 and T4
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.
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.
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.
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

Full Information

First Posted
November 1, 2019
Last Updated
October 25, 2021
Sponsor
University of Copenhagen
Collaborators
US National Cattlemen´s Association, Danish Agriculture and Food Counsel
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1. Study Identification

Unique Protocol Identification Number
NCT04156165
Brief Title
The Effect of High vs. Moderate Protein Consumption on Human Health
Acronym
BEEF
Official Title
BEEF The Effect of High vs. Moderate Protein Consumption on Human Health - With Beef as Major Source of Protein
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
November 10, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
US National Cattlemen´s Association, Danish Agriculture and Food Counsel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Metabolism and Nutrition Disorder, Obesity
Keywords
Body composition, Metabolism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
2x2 factorial intervention trial with two and two arms
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VLCD-Control
Arm Type
Active Comparator
Arm Description
Very low calorie diet, 600 kcal pr day for eight weeks.
Arm Title
VLCD-Active
Arm Type
Experimental
Arm Description
Very low calorie diet plus additional 25 g protein powder, 700 kcal pr day for eight weeks.
Arm Title
Maintenance-Control
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Maintenance-Active
Arm Type
Experimental
Arm Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
VLCD-Active
Other Intervention Name(s)
High protein VLCD
Intervention Description
Lighter life formula products supplied to subjects, four sachets pr day. Dietetic advise given regularly.
Intervention Type
Other
Intervention Name(s)
Maintenance-Active
Other Intervention Name(s)
High protein diet
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
VLCD-Control
Other Intervention Name(s)
Moderat protein VLCD
Intervention Description
Lighter life VLCD products
Intervention Type
Other
Intervention Name(s)
Maintenance-Control
Other Intervention Name(s)
Moderate protein diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body weight
Description
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.
Time Frame
up to week 21
Secondary Outcome Measure Information:
Title
Body composition
Description
Body composition will be assessed by DXA as whole body scan
Time Frame
up to week 21
Title
Glucose metabolism
Description
Measurements of fasting glucose, insulin, HbA1c
Time Frame
up to week 21
Title
Inflammation
Description
Measurements of fasting CRP, plasma lipids
Time Frame
Up to week 21
Title
Fecal samples
Description
Measurement of microbiota (bacteria strains present in feces) and metabolomics markers
Time Frame
Up to week 21
Title
Resting metabolic rate
Description
Resting metabolic rate will be measured by indirect calorimetry, using a ventilated hood system as described by the manufacture
Time Frame
Up to week 21
Title
Endocrine disruptors
Description
Measurement of fasting T3 and T4
Time Frame
Up to week 21
Title
Height
Description
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.
Time Frame
Week 0
Title
Waist circumference
Description
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.
Time Frame
Up to week 21
Title
Hip circumference
Description
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.
Time Frame
Up to week 21
Title
Blood pressure
Description
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
Time Frame
Up to week 21
Other Pre-specified Outcome Measures:
Title
Initial glucose metabolism
Description
To investigate the effect of initial glucose metabolism on the response to high vs. moderate protein diet on weight maintenance.
Time Frame
Up to week 21
Title
Initial microbiota
Description
Statistical investigation of the effect of initial microbiota assessed by fecal sample on weight change
Time Frame
Up to week 21
Title
Initial body composition
Description
Statistical investigation of the effect of initial body composition assessed by DXA scan on weight change.
Time Frame
Up to week 21
Title
Physical activity and sleep
Description
Physical activity and sleep patterns will be measured by an accelerometer (ActiGraph GT3X+) in the 7 days/8 nights
Time Frame
Up to week 21
Title
Perceived stress
Description
Assessed by Perceived Stress Scale questionnaire
Time Frame
Up to week 21
Title
Life quality
Description
Assessed by SF-36 questionnaire
Time Frame
Up to week 21

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arne Astrup, Professor
Organizational Affiliation
Department of Nutrition, Exercise and Sports, UCPH
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Copenhagen
City
Frederiksberg
State/Province
DK
ZIP/Postal Code
1958
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
34749132
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.
Results Reference
derived

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

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