Clinical trial NCT04415632: Low GI Diet Effects on Non-Alcoholic Fatty Liver Disease
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fatty Liver
Nutritional and Metabolic Disease
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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).


Eligibility criteria: 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.

Primary outcomes:
measure: liver fat content
timeFrame: At baseline
measure: liver fat content
timeFrame: 2 weeks
Secondary outcomes:
measure: Gut microbial composition
timeFrame: At baseline
measure: Gut microbial composition
timeFrame: 2 weeks
measure: Blood glucose level
timeFrame: At baseline
measure: Blood glucose level
timeFrame: 2 weeks
measure: Blood insulin levels
timeFrame: At baseline
measure: Blood insulin levels
timeFrame: 2 weeks
measure: blood liver function tests
timeFrame: At baseline
measure: blood liver function test
timeFrame: 2 weeks
measure: blood lipids levels
timeFrame: At baseline
measure: blood lipids levels
timeFrame: 2 weeks
measure: blood gut hormones levels
timeFrame: At baseline
measure: blood gut hormones levels
timeFrame: 2 weeks
measure: Plasma Short Chain Fatty Acids (SCFAs)
timeFrame: At baseline
measure: Plasma Short Chain Fatty Acids (SCFAs)
timeFrame: 2 weeks
measure: Anthropometric measurements
timeFrame: At baseline
measure: Anthropometric measurements
timeFrame: 2 weeks
measure: Body composition Fat Mass
timeFrame: At baseline
measure: Body composition Fat Mass
timeFrame: 2 weeks
measure: Body composition Muscle Mass
timeFrame: At baseline
measure: Body composition Muscle Mass
timeFrame: 2 weeks
measure: Body composition Water Content
timeFrame: At baseline
measure: Body composition Water Content
timeFrame: 2 weeks
measure: Visual analogue scales (VAS)
timeFrame: through study completion, an average of two weeks
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: NIHR Nottingham Clinical Research Facility Nottingham Digestive Diseases Centre
state: Nottinghamshire
Study officials:
References:
citation: 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.