Low GI Diet Effects on Non-Alcoholic Fatty Liver Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-10

Study Completion Date

2023-10-31

Brief Summary

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A 2 x 2 cross-over dietary intervention trial designed to investigate the effects of low glycemic index (LGI) versus high glycemic index (HGI) diet on hepatic fat accumulation and gut microbiota composition in participants with NAFLD.

Participants will be allocated randomly to a 2-week either high GI (HGI) or low GI (LGI) diet followed by a 4-week wash-out period and then the LGI or HGI diet, opposite to the first 2-weeks (N= 16).

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Detailed Description

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Conditions

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Fatty Liver Nutritional and Metabolic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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LGI Diet

low glycemic index diet

Group Type EXPERIMENTAL

low glycemic index diet

Intervention Type OTHER

• Three-day cycle menu of LGI diet will be designed and supplied to each participant in an amount designed to meet their estimated energy requirements. The percentage energy from protein, fat and carbohydrate will be the same in the two diets. Each diet period of the trial will last for two weeks.

HGI Diet

High glycemic index diet

Group Type OTHER

High glycemic index diet

Intervention Type OTHER

Three-day cycle menu of HGI diet will be designed and supplied to each participant in an amount designed to meet their estimated energy requirements. The percentage energy from protein, fat and carbohydrate will be the same in the two diets. Each diet period of the trial will last for two weeks.

Interventions

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low glycemic index diet

• Three-day cycle menu of LGI diet will be designed and supplied to each participant in an amount designed to meet their estimated energy requirements. The percentage energy from protein, fat and carbohydrate will be the same in the two diets. Each diet period of the trial will last for two weeks.

Intervention Type OTHER

High glycemic index diet

Three-day cycle menu of HGI diet will be designed and supplied to each participant in an amount designed to meet their estimated energy requirements. The percentage energy from protein, fat and carbohydrate will be the same in the two diets. Each diet period of the trial will last for two weeks.

Intervention Type OTHER

Other Intervention Names

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LGI HGI

Eligibility Criteria

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Inclusion Criteria

* • Adult males and females aged from 18 to 65 years (balanced number).

* Detected NAFLD by CAP-FibroScan™ \>288dB/m or by MRI-PDFF) \> 5% fat of liver weight.
* Body mass index ≥ 25 kg/m2
* Have current moderate to high GI diet intake of ≥ 60 (Assessed from a completed 7-day food diary).
* Abdominal obesity (Waist circumference \> 102 cm for males and \> 88 cm for females)
* Able to give informed consent.
* Able to undergo MRI/S and CAP-FibroScan™.

Exclusion Criteria

* • Current smokers and excessive alcohol drinkers (\> 14 units/week).

* Perimenopausal (irregular periods) women.
* Participants with other liver abnormalities.
* Participants with history of gastrointestinal surgeries, depression, eating disorders or difficulties.
* Participants using pharmacologic agents for obesity or NAFLD.
* Participants with type 1 diabetes.
* Participants with type 2 diabetes on second line medications (eg GLP-1 analogues, sulfonylureas).
* Participation in any other trial in the last 3 months.
* Participants on any special diets (e.g. vegetarians).
* Intolerance to foods included in the diet plan.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No