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

University of Copenhagen

Status: Completed

Conditions: Weight Loss; Metabolism and Nutrition Disorder; Obesity

Treatments: Dietary Supplement: VLCD-Control; Other: Maintenance-Active; Dietary Supplement: VLCD-Active; Other: Maintenance-Control

Study type: Interventional

Funder types: Other

Identifiers

NCT04156165

B-352

H-19041921 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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 ± 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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110 participants in 4 patient groups

VLCD-Control

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: VLCD-Control

VLCD-Active

Experimental group

Description:

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

Treatment:

Dietary Supplement: VLCD-Active

Maintenance-Control

Active Comparator group

Description:

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).

Treatment:

Other: Maintenance-Control

Maintenance-Active

Experimental group

Description:

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).

Treatment:

Other: Maintenance-Active