BEEF The Effect of High vs. Moderate Protein Consumption on Human Health - With Beef as Major Source of Protein
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Weight Loss
- Sponsor
- University of Copenhagen
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Body weight
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Arne Astrup
Professor. Dr.Med
University of Copenhagen
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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
- Blood pressure(Up to week 21)
- Fecal samples(Up to week 21)
- Waist circumference(Up to week 21)
- Hip circumference(Up to week 21)
- Body composition(up to week 21)
- Resting metabolic rate(Up to week 21)
- Endocrine disruptors(Up to week 21)
- Glucose metabolism(up to week 21)
- Inflammation(Up to week 21)
- Height(Week 0)