The Effect of High vs. Moderate Protein Consumption on Human Health
NCT ID: NCT04156165
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
110 participants
INTERVENTIONAL
2019-11-01
2020-12-31
Brief Summary
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In total 110 overweight and obese volunteers will be included.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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VLCD-Control
Very low calorie diet, 600 kcal pr day for eight weeks.
VLCD-Control
Lighter life VLCD products
VLCD-Active
Very low calorie diet plus additional 25 g protein powder, 700 kcal pr day for eight weeks.
VLCD-Active
Lighter life formula products supplied to subjects, four sachets pr day. Dietetic advise given regularly.
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).
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.
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).
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.
Interventions
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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.
VLCD-Control
Lighter life VLCD products
VLCD-Active
Lighter life formula products supplied to subjects, four sachets pr day. Dietetic advise given regularly.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age, 18-65 years
* Overweight or grade I-II obesity (BMI 28-40.0 kg/m2)
* Provided voluntary written informed consent
Exclusion Criteria
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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US National Cattlemen´s Association
UNKNOWN
Danish Agriculture and Food Counsel
UNKNOWN
University of Copenhagen
OTHER
Responsible Party
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Arne Astrup
Professor. Dr.Med
Principal Investigators
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Arne Astrup, Professor
Role: PRINCIPAL_INVESTIGATOR
Department of Nutrition, Exercise and Sports, UCPH
Locations
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University of Copenhagen
Frederiksberg, DK, Denmark
Countries
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References
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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.
Other Identifiers
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H-19041921
Identifier Type: REGISTRY
Identifier Source: secondary_id
B-352
Identifier Type: -
Identifier Source: org_study_id