Low GI Diet Effects on Non-Alcoholic Fatty Liver Disease

University of Nottingham16 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Fatty Liver Nutritional and Metabolic Disease

Interventions

low glycemic index dietOTHER

• 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.

High glycemic index dietOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

NIHR Nottingham Clinical Research Facility Nottingham Digestive Diseases Centre

Nottingham, Nottinghamshire, United Kingdom

RECRUITING

Outcomes

Primary Outcomes

liver fat content

To assess the difference in liver fat content between LGI and HGI diet groups in participants with NAFLD using MRI/S

Time frame: At baseline

liver fat content

To assess the difference in liver fat content between LGI and HGI diet groups in participants with NAFLD using MRI/S

Time frame: 2 weeks

Secondary Outcomes

Gut microbial composition

To assess the difference in gut microbiota composition between LGI and HGI diet groups in participants with NAFLD using 16S sequencing of rRNA

Time frame: At baseline

Gut microbial composition

To assess the difference in gut microbiota composition between LGI and HGI diet groups in participants with NAFLD using 16S sequencing of rRNA

Time frame: 2 weeks

Blood glucose level

To assess the differences in blood glucose levels between LGI and HGI diet groups in participants with NAFLD using Horiba automated analyser. .

Time frame: At baseline

Blood glucose level

To assess the differences in blood glucose levels between LGI and HGI diet groups in participants with NAFLD using Horiba automated analyser.

Time frame: 2 weeks

Blood insulin levels

To assess the differences in blood insulin levels between LGI and HGI diet groups in participants with NAFLD using radioimmunoassay methods .

Time frame: At baseline

Data from ClinicalTrials.gov

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Blood insulin levels

To assess the differences in blood insulin levels between LGI and HGI diet groups in participants with NAFLD using radioimmunoassay methods .

blood liver function tests

To assess the differences in liver function biomarkers between LGI and HGI diet groups in participants with NAFLD using Horiba automated analyser. The blood liver function tests (LFTs) to be assessed are GGT(Gamma-Glutamyl Transferase), ALP(Alkaline Phosphatase), AST(Aspartate Amino Transferase), and ALT(Alanine Amino Transferase)

Time frame: At baseline

blood liver function test

Time frame: 2 weeks

blood lipids levels

To assess the differences in blood lipids levels between LGI and HGI diet groups in participants with NAFLD using Horiba automated analyser. The blood lipids biomarkers to be assessed are Total Cholesterol, Free Fatty Acids, High-density lipoprotein, low-density lipoprotein, Triglycerides.

Time frame: At baseline

blood lipids levels

Time frame: 2 weeks

blood gut hormones levels

To assess the differences in blood gut hormones levels between LGI and HGI diet groups in participants with NAFLD using radioimmunoassay (RIA) or Sandwich ELISA methods. The blood gut hormones to be assessed are Glucagon, Leptin, Ghrelin, PYY (Peptide YY), GLP-1 (Glucagon-like peptide 1).

Time frame: At baseline

blood gut hormones levels

Time frame: 2 weeks

Plasma Short Chain Fatty Acids (SCFAs)

To investigate the differences in plasma SCFAs between LGI and HGI diet groups in participants with NAFLD.

Time frame: At baseline

Plasma Short Chain Fatty Acids (SCFAs)

To investigate the differences in plasma SCFAs between LGI and HGI diet groups in participants with NAFLD.

Time frame: 2 weeks

Anthropometric measurements

Weight in kg, Height in meters will be combined to report BMI kg/m\^2 or each study arm

Time frame: At baseline

Anthropometric measurements

Weight in kg, Height in meters will be combined to report BMI kg/m\^2 or each study arm

Time frame: 2 weeks

Body composition Fat Mass

Bio-electrical Impedance analysis (BIA) will be used to assess the body composition of fat mass %.

Time frame: At baseline

Body composition Fat Mass

Bio-electrical Impedance analysis (BIA) will be used to assess the body composition of fat mass %.

Time frame: 2 weeks

Body composition Muscle Mass

Bio-electrical Impedance analysis (BIA) will be used to assess the body composition of muscle mass %.

Time frame: At baseline

Body composition Muscle Mass

Bio-electrical Impedance analysis (BIA) will be used to assess the body composition of muscle mass %.

Time frame: 2 weeks

Body composition Water Content

Bio-electrical Impedance analysis (BIA) will be used to assess the body composition of water content %.

Time frame: At baseline

Body composition Water Content

Bio-electrical Impedance analysis (BIA) will be used to assess the body composition of water content %.

Time frame: 2 weeks

Visual analogue scales (VAS)

Visual analogue scales (VAS) in 0 to 10 cm scale will be used to assess the participant's subjective appetite (hunger and fullness) during the each study arm.

Time frame: through study completion, an average of two weeks