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Weight LossBEEFNCT04156165

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

A study testing VLCD-Active and Maintenance-Active in people with Weight Loss and Metabolism and Nutrition Disorder, run by University of Copenhagen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
VLCD-Active and Maintenance-Active
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteDenmark
Study dates
1 Nov 2019to 31 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • University of Copenhagen

    Frederiksberg, DK, 1958

Other trials in Denmark

About this study

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

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.

Being tested
VLCD-Active, Maintenance-Active, VLCD-Control, Maintenance-Control
Keywords
Body composition, Metabolism
Medical subject headings
Weight Loss, Nutrition Disorders, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VLCD-ActiveDietary supplement

    Also called High protein VLCD

    Lighter life formula products supplied to subjects, four sachets pr day. Dietetic advise given regularly.

  • Maintenance-ActiveOther

    Also called High protein diet

    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.

  • VLCD-ControlDietary supplement

    Also called Moderat protein VLCD

    Lighter life VLCD products

  • Maintenance-ControlOther

    Also called Moderate protein diet

    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.

Study groups in NCT04156165
Study groupRoleWhat they receive
VLCD-ControlActive comparatorVery low calorie diet, 600 kcal pr day for eight weeks.
Receives: Dietary Supplement: VLCD-Control
VLCD-ActiveExperimentalVery low calorie diet plus additional 25 g protein powder, 700 kcal pr day for eight weeks.
Receives: Dietary Supplement: VLCD-Active
Maintenance-ControlActive comparator12-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).
Receives: Other: Maintenance-Control
Maintenance-ActiveExperimental12-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).
Receives: Other: Maintenance-Active

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: up to week 21

Secondary outcomes (10)

  1. Body composition

    Body composition will be assessed by DXA as whole body scan

    Measured: up to week 21

  2. Glucose metabolism

    Measurements of fasting glucose, insulin, HbA1c

    Measured: up to week 21

  3. Inflammation

    Measurements of fasting CRP, plasma lipids

    Measured: Up to week 21

  4. Fecal samples

    Measurement of microbiota (bacteria strains present in feces) and metabolomics markers

    Measured: Up to week 21

  5. Resting metabolic rate

    Resting metabolic rate will be measured by indirect calorimetry, using a ventilated hood system as described by the manufacture

    Measured: Up to week 21

  6. Endocrine disruptors

    Measurement of fasting T3 and T4

    Measured: Up to week 21

  7. 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.

    Measured: Week 0

  8. 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.

    Measured: Up to week 21

  9. 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.

    Measured: Up to week 21

  10. 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

    Measured: Up to week 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2019
  2. Study start1 Nov 2019
  3. Primary completion10 Nov 2020
  4. Study completion31 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Model description
2x2 factorial intervention trial with two and two arms
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04156165
Sponsor's protocol ID
B-352
Other IDs
H-19041921
Acronym
BEEF
Status last verified
Oct 2021
First submitted
1 Nov 2019
Last updated
1 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Magkos F, Hjorth MF, Asping S, Rosenkrans MI, Rasmussen SI, Ritz C, Sjodin A, Geiker NRW. A protein-supplemented very-low-calorie diet does not mitigate reductions in lean mass and resting metabolic rate in subjects with overweight or obesity: A randomized controlled trial. Clin Nutr. 2021 Dec;40(12):5726-5733. doi: 10.1016/j.clnu.2021.10.006. Epub 2021 Oct 18.

    PubMed 34749132

Questions about this trial

What is this clinical trial studying?

A study testing VLCD-Active and Maintenance-Active in people with Weight Loss and Metabolism and Nutrition Disorder, run by University of Copenhagen at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body weight (time frame: up to week 21). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04156165, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.

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