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

Study Overview
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Brief Summary
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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.

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

Conditions
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Weight Loss, Metabolism and Nutrition Disorder, Obesity

Intervention / Treatment
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* Dietary Supplement: VLCD-Active
* Other: Maintenance-Active
* Dietary Supplement: VLCD-Control
* Other: Maintenance-Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: 2x2 factorial intervention trial with two and two arms
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: VLCD-Control<br>Very low calorie diet, 600 kcal pr day for eight weeks. | Dietary Supplement: VLCD-Control<br>* Lighter life VLCD products<br>* Other names: Moderat protein VLCD;|
| Experimental: VLCD-Active<br>Very low calorie diet plus additional 25 g protein powder, 700 kcal pr day for eight weeks. | Dietary Supplement: VLCD-Active<br>* Lighter life formula products supplied to subjects, four sachets pr day. Dietetic advise given regularly.<br>* Other names: High protein VLCD;|
| Active Comparator: Maintenance-Control<br>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). | Other: Maintenance-Control<br>* 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.<br>* Other names: Moderate protein diet;|
| Experimental: Maintenance-Active<br>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). | Other: Maintenance-Active<br>* 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.<br>* Other names: High protein diet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Body composition, Metabolism