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

Not Applicable

Completed

• Conditions: Weight Loss; Metabolism and Nutrition Disorder; Obesity

• Registration Number: NCT04156165
• Lead Sponsor: University of Copenhagen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-01
• Study First Submitted: 2019-11-01
• Study First Submitted QC: 2019-11-05
• Study First Posted: 2019-11-07
• Primary Completion: 2020-11-10
• Study Completion: 2020-12-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-25
• Last Update Posted: 2021-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Body weight	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 Outcome Measures

Name	Time	Method
Blood pressure	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
Fecal samples	Up to week 21	Measurement of microbiota (bacteria strains present in feces) and metabolomics markers
Waist circumference	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.
Hip circumference	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.
Resting metabolic rate	Up to week 21	Resting metabolic rate will be measured by indirect calorimetry, using a ventilated hood system as described by the manufacture
Endocrine disruptors	Up to week 21	Measurement of fasting T3 and T4
Glucose metabolism	up to week 21	Measurements of fasting glucose, insulin, HbA1c
Inflammation	Up to week 21	Measurements of fasting CRP, plasma lipids
Height	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.
Body composition	up to week 21	Body composition will be assessed by DXA as whole body scan

Trial Locations

Locations (1)

University of Copenhagen; 🇩🇰 Frederiksberg, DK, Denmark