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

Overview

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.

Full Title of Study: “BEEF The Effect of High vs. Moderate Protein Consumption on Human Health – With Beef as Major Source of Protein”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 31, 2020

Interventions

  • 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.

Arms, Groups and Cohorts

  • Active Comparator: VLCD-Control
    • Very low calorie diet, 700 kcal pr day for eight weeks.
  • Experimental: VLCD-Active
    • Very low calorie diet plus additional 25 g protein powder, 800 kcal pr day for eight weeks.
  • Active Comparator: 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).
  • Experimental: 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).

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Body composition
    • Time Frame: up to week 21
    • Body composition will be assessed by DXA as whole body scan
  • Glucose metabolism
    • Time Frame: up to week 21
    • Measurements of fasting glucose, insulin, HbA1c
  • Inflammation
    • Time Frame: Up to week 21
    • Measurements of fasting CRP, plasma lipids
  • Fecal samples
    • Time Frame: Up to week 21
    • Measurement of microbiota (bacteria strains present in feces) and metabolomics markers
  • 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
  • Endocrine disruptors
    • Time Frame: Up to week 21
    • Measurement of fasting T3 and T4
  • 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.
  • 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.
  • 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.
  • 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

Participating in This Clinical Trial

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 ┬▒ 3 kg 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Copenhagen
  • Collaborator
    • US National Cattlemen┬┤s Association
  • Provider of Information About this Clinical Study
    • Principal Investigator: Arne Astrup, Professor. Dr.Med – University of Copenhagen
  • Overall Official(s)
    • Arne Astrup, Professor, Principal Investigator, Department of Nutrition, Exercise and Sports, UCPH
  • Overall Contact(s)
    • Nina RW Geiker, PhD, +45 3532 4060, geiker@nexs.ku.dk

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