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

Obesity Clinical Trial

— BEEF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04156165
• Other study ID #: B-352
• Secondary ID: H-19041921
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2021
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 31, 2020
• Est. primary completion date: November 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolism and Nutrition Disorder
• Nutrition Disorders
• Obesity
• Weight Loss

Intervention

Dietary Supplement:
• VLCD-Active
Lighter life formula products supplied to subjects, four sachets pr day. Dietetic advise given regularly.

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.

Dietary Supplement:
• VLCD-Control
Lighter life VLCD products

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.

Locations

Country	Name	City	State
Denmark	University of Copenhagen	Frederiksberg	DK

Sponsors (3)

Lead Sponsor	Collaborator
University of Copenhagen	Danish Agriculture and Food Counsel, US National Cattlemen´s Association

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Initial microbiota	Statistical investigation of the effect of initial microbiota assessed by fecal sample on weight change	Up to week 21
Other	Initial body composition	Statistical investigation of the effect of initial body composition assessed by DXA scan on weight change.	Up to week 21
Other	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
Other	Perceived stress	Assessed by Perceived Stress Scale questionnaire	Up to week 21
Other	Life quality	Assessed by SF-36 questionnaire	Up to week 21
Primary	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	Body composition	Body composition will be assessed by DXA as whole body scan	up to week 21
Secondary	Glucose metabolism	Measurements of fasting glucose, insulin, HbA1c	up to week 21
Secondary	Inflammation	Measurements of fasting CRP, plasma lipids	Up to week 21
Secondary	Fecal samples	Measurement of microbiota (bacteria strains present in feces) and metabolomics markers	Up to week 21
Secondary	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
Secondary	Endocrine disruptors	Measurement of fasting T3 and T4	Up to week 21
Secondary	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
Secondary	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
Secondary	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
Secondary	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