Low GI Diet Effects on Non-Alcoholic Fatty Liver Disease (LGI-NAFLD)

University of Nottingham

Status: Unknown

Conditions: Fatty Liver; Nutritional and Metabolic Disease

Treatments: Other: low glycemic index diet; Other: High glycemic index diet

Study type: Interventional

Funder types: Other

Identifiers

NCT04415632

19042

19/EM/0291 (Other Identifier)

262245 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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16 participants in 2 patient groups

LGI Diet

Experimental group

Description:

low glycemic index diet

Treatment:

Other: low glycemic index diet

HGI Diet

Other group

Description:

High glycemic index diet

Treatment:

Other: High glycemic index diet