BEEF The Effect of High vs. Moderate Protein Consumption on Human Health - With Beef as Major Source of Protein
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Copenhagen
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Body weight
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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
Arms & Interventions
VLCD-Control
Very low calorie diet, 600 kcal pr day for eight weeks.
Intervention: VLCD-Control (Dietary Supplement)
VLCD-Active
Very low calorie diet plus additional 25 g protein powder, 700 kcal pr day for eight weeks.
Intervention: VLCD-Active (Dietary Supplement)
Maintenance-Control
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).
Intervention: Maintenance-Control (Other)
Maintenance-Active
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: Maintenance-Active (Other)
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)
Investigators
Arne Astrup
Professor. Dr.Med
University of Copenhagen