Low GI Diet Effects on Non-Alcoholic Fatty Liver Disease

Not Applicable

• Conditions: Fatty Liver; Nutritional and Metabolic Disease
• Interventions: Other: low glycemic index diet; Other: High glycemic index diet

• Registration Number: NCT04415632
• Lead Sponsor: University of Nottingham

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-20
• Study First Submitted QC: 2020-05-29
• Study First Posted: 2020-06-04
• Study Start: 2020-12-10
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-28
• Last Update Posted: 2021-09-29
• Primary Completion: 2022-10
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LGI Diet	low glycemic index diet	low glycemic index diet
HGI Diet	High glycemic index diet	High glycemic index diet

Primary Outcome Measures

Name	Time	Method
liver fat content	2 weeks	To assess the difference in liver fat content between LGI and HGI diet groups in participants with NAFLD using MRI/S

Secondary Outcome Measures

Name	Time	Method
Blood glucose level	2 weeks	To assess the differences in blood glucose levels between LGI and HGI diet groups in participants with NAFLD using Horiba automated analyser.
Blood insulin levels	2 weeks	To assess the differences in blood insulin levels between LGI and HGI diet groups in participants with NAFLD using radioimmunoassay methods .
Gut microbial composition	2 weeks	To assess the difference in gut microbiota composition between LGI and HGI diet groups in participants with NAFLD using 16S sequencing of rRNA
blood liver function tests	At baseline	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)
Plasma Short Chain Fatty Acids (SCFAs)	2 weeks	To investigate the differences in plasma SCFAs between LGI and HGI diet groups in participants with NAFLD.
Anthropometric measurements	2 weeks	Weight in kg, Height in meters will be combined to report BMI kg/m\^2 or each study arm
Body composition Fat Mass	2 weeks	Bio-electrical Impedance analysis (BIA) will be used to assess the body composition of fat mass %.
Body composition Water Content	2 weeks	Bio-electrical Impedance analysis (BIA) will be used to assess the body composition of water content %.
blood lipids levels	2 weeks	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.
blood gut hormones levels	2 weeks	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).
blood liver function test	2 weeks	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)
Body composition Muscle Mass	2 weeks	Bio-electrical Impedance analysis (BIA) will be used to assess the body composition of muscle mass %.
Visual analogue scales (VAS)	through study completion, an average of two weeks	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.

Trial Locations

Locations (1)

NIHR Nottingham Clinical Research Facility Nottingham Digestive Diseases Centre; 🇬🇧 Nottingham, Nottinghamshire, United Kingdom