Low GI Diet Effects on Non-Alcoholic Fatty Liver Disease

Fatty Liver Clinical Trial

— LGI-NAFLD  

Official title:

Effects of an Iso-energetic Low Glycemic Index (GI) Diet on Liver Fat Accumulation and Gut Microbiota Composition in Patients With Non- Alcoholic Fatty Liver Disease (NAFLD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04415632
• Other study ID #: 19042
• Secondary ID: 26224519/EM/0291
• Status: Recruiting
• Phase: N/A
• Start date: December 10, 2020
• Est. completion date: October 2023

Study information

• Verified date: September 2021
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: October 2023
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Metabolic Diseases
• Non-alcoholic Fatty Liver Disease
• Nutritional and Metabolic Disease

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
United Kingdom	NIHR Nottingham Clinical Research Facility Nottingham Digestive Diseases Centre	Nottingham	Nottinghamshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	liver fat content	To assess the difference in liver fat content between LGI and HGI diet groups in participants with NAFLD using MRI/S	At baseline
Primary	liver fat content	To assess the difference in liver fat content between LGI and HGI diet groups in participants with NAFLD using MRI/S	2 weeks
Secondary	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	At baseline
Secondary	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	2 weeks
Secondary	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.; .	At baseline
Secondary	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.	2 weeks
Secondary	Blood insulin levels	To assess the differences in blood insulin levels between LGI and HGI diet groups in participants with NAFLD using radioimmunoassay methods .	At baseline
Secondary	Blood insulin levels	To assess the differences in blood insulin levels between LGI and HGI diet groups in participants with NAFLD using radioimmunoassay methods .	2 weeks
Secondary	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)	At baseline
Secondary	blood liver function test	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)	2 weeks
Secondary	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.	At baseline
Secondary	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.	2 weeks
Secondary	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).	At baseline
Secondary	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).	2 weeks
Secondary	Plasma Short Chain Fatty Acids (SCFAs)	To investigate the differences in plasma SCFAs between LGI and HGI diet groups in participants with NAFLD.	At baseline
Secondary	Plasma Short Chain Fatty Acids (SCFAs)	To investigate the differences in plasma SCFAs between LGI and HGI diet groups in participants with NAFLD.	2 weeks
Secondary	Anthropometric measurements	Weight in kg, Height in meters will be combined to report BMI kg/m^2 or each study arm	At baseline
Secondary	Anthropometric measurements	Weight in kg, Height in meters will be combined to report BMI kg/m^2 or each study arm	2 weeks
Secondary	Body composition Fat Mass	Bio-electrical Impedance analysis (BIA) will be used to assess the body composition of fat mass %.	At baseline
Secondary	Body composition Fat Mass	Bio-electrical Impedance analysis (BIA) will be used to assess the body composition of fat mass %.	2 weeks
Secondary	Body composition Muscle Mass	Bio-electrical Impedance analysis (BIA) will be used to assess the body composition of muscle mass %.	At baseline
Secondary	Body composition Muscle Mass	Bio-electrical Impedance analysis (BIA) will be used to assess the body composition of muscle mass %.	2 weeks
Secondary	Body composition Water Content	Bio-electrical Impedance analysis (BIA) will be used to assess the body composition of water content %.	At baseline
Secondary	Body composition Water Content	Bio-electrical Impedance analysis (BIA) will be used to assess the body composition of water content %.	2 weeks
Secondary	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.	through study completion, an average of two weeks