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

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ClinicalTrials.gov Identifier: NCT04156165
Recruitment Status : Recruiting
First Posted : November 7, 2019
Last Update Posted : November 7, 2019
Sponsor:
Collaborators:
US National Cattlemen´s Association
Danish Agriculture and Food Counsel
Information provided by (Responsible Party):
Arne Astrup, 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.


Condition or disease Intervention/treatment Phase
Weight Loss Metabolism and Nutrition Disorder Obesity Dietary Supplement: VLCD-Active Other: Maintenance-Active Dietary Supplement: VLCD-Control Other: Maintenance-Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel randomized controlled intervention trial with two and two arms
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: BEEF The Effect of High vs. Moderate Protein Consumption on Human Health - With Beef as Major Source of Protein
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Active Comparator: VLCD-Control
Very low calorie diet, 700 kcal pr day for eight weeks.
Dietary Supplement: VLCD-Control
Lighter life VLCD products
Other Name: Moderat protein VLCD

Experimental: VLCD-Active
Very low calorie diet plus additional 25 g protein powder, 800 kcal pr day for eight weeks.
Dietary Supplement: VLCD-Active
Lighter life formula products supplied to subjects, four sachets pr day. Dietetic advise given regularly.
Other Name: High protein VLCD

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).

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.
Other Name: Moderate protein diet

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).
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.
Other Name: High protein diet




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Body composition [ Time Frame: up to week 21 ]
    Body composition will be assessed by DXA as whole body scan

  2. Glucose metabolism [ Time Frame: up to week 21 ]
    Measurements of fasting glucose, insulin, HbA1c

  3. Inflammation [ Time Frame: Up to week 21 ]
    Measurements of fasting CRP, plasma lipids

  4. Fecal samples [ Time Frame: Up to week 21 ]
    Measurement of microbiota (bacteria strains present in feces) and metabolomics markers

  5. 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

  6. Endocrine disruptors [ Time Frame: Up to week 21 ]
    Measurement of fasting T3 and T4

  7. 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.

  8. 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.

  9. 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.

  10. 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


Other Outcome Measures:
  1. Initial glucose metabolism [ Time Frame: Up to week 21 ]
    To investigate the effect of initial glucose metabolism on the response to high vs. moderate protein diet on weight maintenance.

  2. Initial microbiota [ Time Frame: Up to week 21 ]
    Statistical investigation of the effect of initial microbiota assessed by fecal sample on weight change

  3. Initial body composition [ Time Frame: Up to week 21 ]
    Statistical investigation of the effect of initial body composition assessed by DXA scan on weight change.

  4. Physical activity and sleep [ Time Frame: Up to week 21 ]
    Physical activity and sleep patterns will be measured by an accelerometer (ActiGraph GT3X+) in the 7 days/8 nights

  5. Perceived stress [ Time Frame: Up to week 21 ]
    Assessed by Perceived Stress Scale questionnaire

  6. Life quality [ Time Frame: Up to week 21 ]
    Assessed by SF-36 questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 ± 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04156165


Contacts
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Contact: Nina RW Geiker, PhD +45 3532 4060 geiker@nexs.ku.dk
Contact: Mads F Hjorth, PhD madsfiil@life.ku.dk

Locations
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Denmark
University of Copenhagen Recruiting
Frederiksberg, DK, Denmark, 1958
Contact: Nina RW Geiker, PhD    +4535324060    geiker@nexs.ku.dk   
Contact: Mads F Hjorth, PhD       madsfiil@life.ku.dk   
Sponsors and Collaborators
University of Copenhagen
US National Cattlemen´s Association
Danish Agriculture and Food Counsel
Investigators
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Principal Investigator: Arne Astrup, Professor Department of Nutrition, Exercise and Sports, UCPH

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Responsible Party: Arne Astrup, Professor. Dr.Med, University of Copenhagen
ClinicalTrials.gov Identifier: NCT04156165     History of Changes
Other Study ID Numbers: B-352
H-19041921 ( Registry Identifier: Danish Ethical Committee )
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arne Astrup, University of Copenhagen:
Body composition
Metabolism
Additional relevant MeSH terms:
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Nutrition Disorders
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms