Glycemic Index/Saturated Fatty Acid Diet and Hepatic Fat

NCT04054297 | Completed

• 1 other identifier: NL69685.068.19
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

NAFLD; Diet; Glycemic index

Outcome Measures

Primary Outcomes (1)

• Hepatic fat content

  Expressed as a percentage, measured by 1H-MRS

  20 minutes

Secondary Outcomes (3)

• Hepatic De Novo Lipogenesis

  20 hours

• Hepatic fat composition (%SFA, MUFA, PUFA)

  20 minutes

• Hepatic glycogen content

  20 minutes

Study Arms (2)

High GI/SFA diet

EXPERIMENTAL

Subjects will adhere to a two-week high GI and high SFA diet. Crossover design, randomly assigned to start with either high GI/SFA or low GI/SFA. 4 week washout between the two diets.

Behavioral: High GI/SFA diet

Low GI/SFA diet

EXPERIMENTAL

Subjects will adhere to a two-week low GI and low SFA diet. Crossover design, randomly assigned to start with either high GI/SFA or low GI/SFA. 4 week washout between the two diets.

Behavioral: Low GI/SFA diet

Interventions

High GI/SFA diet BEHAVIORAL

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

High GI/SFA diet

Low GI/SFA diet BEHAVIORAL

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

Low GI/SFA diet

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Caucasian
• Male or postmenopausal female
• Aged 45-75 years at start of the study
• Body mass index (BMI) 27 - 38 kg/m2
• Stable dietary habits (no weight loss or gain \>3kg in the past 3 months) Sedentary lifestyle (not more than 2 hours of sports per week)
• TG between 1.0 and 4.0 mmol/L

You may not qualify if:

• Type 2 diabetes
• Any acute condition, exacerbation of chronic condition, or medical history that would in the investigator's or dependent physician's opinion interfere with the study
• Contra-indication for MRI (which can be found in appendix II)
• Alcohol consumption of \>2 servings per day
• Smoking
• Use of medication known to interfere with the safety of study procedures

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Unilever R&D: collaborator

Study Sites (1)

Maastricht University

Maastricht, 6229 ER, Netherlands

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Obesity

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Vera Schrauwen-Hinderling, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: August 13, 2019
• Study Start: July 22, 2019
• Primary Completion: March 23, 2021
• Study Completion: March 23, 2021
• Last Updated: July 20, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)