Glycemic Index/Saturated Fatty Acid Diet and Hepatic Fat

NCT04054297 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2021-07-20

No results posted yet for this study

Summary

Excessive fat in the liver is associated with impairments in metabolic health. Reducing the amount of carbohydrates and fat both have been shown to reduce liver fat. However, not only the amount fats and carbohydrates, but also their quality have been shown to influence liver fat. Diets high in saturated fatty acids (SFA) and diets with a high glycemic index (GI) have been shown to increase liver fat content. However, available data from human dietary intervention studies is limited and these studies did not reflect a realistic diet. In the present study a combination of low GI/SFA on the one hand and high GI/SFA on the other hand is used to reflect realistically a healthy and an unhealthy diet as they are actually consumed by the Dutch population.

The primary objective of this study is to investigate whether a two-week low compared to high GI/SFA diet reduces liver fat content. In addition, it will be investigated whether a two- week low compared to high GI/SFA diet reduces DNL, lowers the 24-hour glycemic response, lowers hepatic glycogen content, increases hepatic fat oxidation and changes hepatic lipid composition. Furthermore, the metabolic response to a meal (metabolites related to energy metabolism and substrate oxidation) will be studied upon the low and high GI/SFA diets.

Conditions

  • Fatty Liver, Nonalcoholic
  • Diet, Healthy
  • Obesity

Interventions

BEHAVIORAL

High GI/SFA diet

Subject will adhere to a 2 week high GI/SFA diet.

BEHAVIORAL

Low GI/SFA diet

Subject will adhere to a 2 week low GI/SFA diet.

Sponsors & Collaborators

  • Unilever R&D

    collaborator INDUSTRY
  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Vera Schrauwen-Hinderling, PhD · Maastricht University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-22
Primary Completion
2021-03-23
Completion
2021-03-23

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04054297 on ClinicalTrials.gov