Skip to main content
OpenTrials
Completed

NCT Number: NCT04156165

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Weight Loss Body Weight Body Weight Changes Metabolism and Nutrition Disorder Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Copenhagen

Frederiksberg, DK, 1958, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VLCD-Active

Dietary Supplement

Lighter life formula products supplied to subjects, four sachets pr day. Dietetic advise given regularly.

Other names: High protein VLCD

Maintenance-Active

Other

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

VLCD-Control

Dietary Supplement

Lighter life VLCD products

Other names: Moderat protein VLCD

Maintenance-Control

Other

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

Primary outcomes

  1. Body weight

    Time frame: up to week 21

    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 outcomes

  1. Body composition

    Time frame: up to week 21

    Body composition will be assessed by DXA as whole body scan

  2. Glucose metabolism

    Time frame: up to week 21

    Measurements of fasting glucose, insulin, HbA1c

  3. Inflammation

    Time frame: Up to week 21

    Measurements of fasting CRP, plasma lipids

  4. Fecal samples

    Time frame: Up to week 21

    Measurement of microbiota (bacteria strains present in feces) and metabolomics markers

  5. Resting metabolic rate

    Time frame: Up to week 21

    Resting metabolic rate will be measured by indirect calorimetry, using a ventilated hood system as described by the manufacture

  6. Endocrine disruptors

    Time frame: Up to week 21

    Measurement of fasting T3 and T4

  7. Height

    Time frame: Week 0

    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.

  8. Waist circumference

    Time frame: Up to week 21

    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.

  9. Hip circumference

    Time frame: Up to week 21

    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.

  10. Blood pressure

    Time frame: Up to week 21

    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

Other outcomes

  1. Initial glucose metabolism

    Time frame: Up to week 21

    To investigate the effect of initial glucose metabolism on the response to high vs. moderate protein diet on weight maintenance.

  2. Initial microbiota

    Time frame: Up to week 21

    Statistical investigation of the effect of initial microbiota assessed by fecal sample on weight change

  3. Initial body composition

    Time frame: Up to week 21

    Statistical investigation of the effect of initial body composition assessed by DXA scan on weight change.

  4. Physical activity and sleep

    Time frame: Up to week 21

    Physical activity and sleep patterns will be measured by an accelerometer (ActiGraph GT3X+) in the 7 days/8 nights

  5. Perceived stress

    Time frame: Up to week 21

    Assessed by Perceived Stress Scale questionnaire

  6. Life quality

    Time frame: Up to week 21

    Assessed by SF-36 questionnaire

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Danish Agriculture and Food Counsel
  • US National Cattlemen´s Association

Registry information

Official study title

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

Acronym: BEEF

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 7, 2019
Registry last updated
Nov 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.