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

NCT04156165 | Completed

• 2 other identifiers: B-352H-19041921
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Loss; Metabolism and Nutrition Disorder; Obesity

Keywords

Body composition; Metabolism

Outcome Measures

Primary Outcomes (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.

  up to week 21

Secondary Outcomes (10)

• Body composition

  up to week 21

• Glucose metabolism

  up to week 21

• Inflammation

  Up to week 21

• Fecal samples

  Up to week 21

• Resting metabolic rate

  Up to week 21

Other Outcomes (6)

• Initial glucose metabolism

  Up to week 21

• Initial microbiota

  Up to week 21

• Initial body composition

  Up to week 21

Study Arms (4)

VLCD-Control

ACTIVE COMPARATOR

Very low calorie diet, 600 kcal pr day for eight weeks.

Dietary Supplement: VLCD-Control

VLCD-Active

EXPERIMENTAL

Very low calorie diet plus additional 25 g protein powder, 700 kcal pr day for eight weeks.

Dietary Supplement: VLCD-Active

Maintenance-Control

ACTIVE COMPARATOR

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

Maintenance-Active

EXPERIMENTAL

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

Interventions

VLCD-Active DIETARY_SUPPLEMENT

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

Also known as: High protein VLCD

VLCD-Active

Maintenance-Active OTHER

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.

Also known as: High protein diet

Maintenance-Active

VLCD-Control DIETARY_SUPPLEMENT

Lighter life VLCD products

Also known as: Moderat protein VLCD

VLCD-Control

Maintenance-Control OTHER

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.

Also known as: Moderate protein diet

Maintenance-Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Copenhagen: lead
• US National Cattlemen´s Association: collaborator
• Danish Agriculture and Food Counsel: collaborator

Study Sites (1)

University of Copenhagen

Frederiksberg, DK, 1958, Denmark

Location

Related Publications (1)

• 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.

  PMID: 34749132 DERIVED

MeSH Terms

Conditions

Weight Loss; Nutrition Disorders; Obesity

Interventions

Diet, High-Protein

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Overweight; Overnutrition

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Arne Astrup, Professor

  Department of Nutrition, Exercise and Sports, UCPH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor. Dr.Med

Model Details: 2x2 factorial intervention trial with two and two arms

Study Record Dates

• First Submitted: November 1, 2019
• First Posted: November 7, 2019
• Study Start: November 1, 2019
• Primary Completion: November 10, 2020
• Study Completion: December 31, 2020
• Last Updated: November 1, 2021

Record last verified: 2021-10

Locations

DK (1)