Dietary Protein and Hepatic Fat Accumulation

NCT ID: NCT01354626

Last Updated: 2012-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2012-03-31

Brief Summary

The objective of this study is to investigate the potential beneficial effect of increasing protein in the diet in order to decrease hepatic lipid accumulation on a high-fat diet.

The investigators hypothesize that increasing protein in a high-fat diet suppresses lipid accumulation in the liver, and that changes in (hepatic) fat handling underlie this reduced lipid accumulation.

Conditions

Hepatic Fat Accumulation; Nonalcoholic Fatty Liver Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

High fat diets

High-fat-Low-protein or High-fat-high-protein

Group Type: EXPERIMENTAL

dietary protein

Intervention Type: OTHER

in the low-protein group 13EN% of protein will be provided in the diet; in the high-protein 25EN% of protein will be provided

Control group

Low-protein-low-fat (according to healthy eating guidelines)

Group Type: OTHER

low-protein

Intervention Type: OTHER

The control group will get a diet which is according to healthy eating guidelines.

Interventions

dietary protein

in the low-protein group 13EN% of protein will be provided in the diet; in the high-protein 25EN% of protein will be provided

Intervention Type: OTHER

low-protein

The control group will get a diet which is according to healthy eating guidelines.

Intervention Type: OTHER

Other Intervention Names

diet; diet

Eligibility Criteria

Inclusion Criteria

• Healthy
• body mass index (BMI) 18-25 kg/ m2;
• stable dietary habits;
• physical activity levels.
• caucasian

Exclusion Criteria

• Unable or unwilling to comply with study procedures;
• not caucasian
• Unstable body weight (weight gain or loss > 3 kg in the past three months);
• Moderate intense physical activity (exercise) for more than 4 hours/week;
• (Chronic) disease which might influence the study outcomes e.g. diabetes mellitus or any other endocrine disorder, active cardiovascular disease, hepatic disease, renal disease, cancer;
• Family history of diabetes mellitus;
• Use of medication, except incidental use of paracetamol;
• Abuse of drugs;
• Alcohol consumption of more than 14 glasses per week;
• Participation in another biomedical study within 1 months prior to the first screening visit;
• Contraindications to MRI scanning. These contraindications include patients with one of the following conditions:
• Claustrophobia;
• Central nervous system aneurysm clips;
• Implanted neural stimulator;
• Implanted cardiac pacemaker or defibrillator;
• Cochlear implant;
• Ocular foreign body (e.g. metal shavings);
• Insulin pump;
• Metal shrapnel or bullet;
• Or metal containing corpora aliena in the eye of brains.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wageningen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Wageningen University, Division of Human Nutrition

Wageningen, Gelderland, Netherlands

Countries

Netherlands

References

Rietman A, Schwarz J, Blokker BA, Siebelink E, Kok FJ, Afman LA, Tome D, Mensink M. Increasing protein intake modulates lipid metabolism in healthy young men and women consuming a high-fat hypercaloric diet. J Nutr. 2014 Aug;144(8):1174-80. doi: 10.3945/jn.114.191072. Epub 2014 Jun 4.

Reference Type: DERIVED

PMID: 24899158 (View on PubMed)

Other Identifiers

LiF-Pro

Identifier Type: -

Identifier Source: org_study_id