Low GI Diet Effects on Non-Alcoholic Fatty Liver Disease

NCT04415632 | Unknown

• 3 other identifiers: 1904226224519/EM/0291
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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).

Conditions

Fatty Liver; Nutritional and Metabolic Disease

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (23)

• Gut microbial composition

  At baseline

• Gut microbial composition

  2 weeks

• Blood glucose level

  At baseline

• Blood glucose level

  2 weeks

• Blood insulin levels

  At baseline

Study Arms (2)

LGI Diet

EXPERIMENTAL

low glycemic index diet

Other: low glycemic index diet

HGI Diet

OTHER

High glycemic index diet

Other: High glycemic index diet

Interventions

low glycemic index diet 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.

Also known as: LGI

LGI Diet

High glycemic index diet 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.

Also known as: HGI

HGI Diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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™.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

NIHR Nottingham Clinical Research Facility Nottingham Digestive Diseases Centre

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

RECRUITING

Related Publications (1)

• Al-Awadi A, Grove J, Taylor M, Valdes A, Vijay A, Bawden S, Gowland P, Aithal G. Effects of an isoenergetic low Glycaemic Index (GI) diet on liver fat accumulation and gut microbiota composition in patients with non-alcoholic fatty liver disease (NAFLD): a study protocol of an efficacy mechanism evaluation. BMJ Open. 2021 Oct 7;11(10):e045802. doi: 10.1136/bmjopen-2020-045802.

  PMID: 34620653 DERIVED

MeSH Terms

Conditions

Fatty Liver; Metabolic Diseases

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: June 4, 2020
• Study Start: December 10, 2020
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2023
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: within five years time-frame
• Access Criteria: Public repository. presented at local and international conferences. part of a Philosophy Doctorate thesis

Locations

GB (1)