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

Primary Purpose

Fatty Liver, Nutritional and Metabolic Disease

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
low glycemic index diet
High glycemic index diet
Sponsored by
University of Nottingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Fatty Liver

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • NIHR Nottingham Clinical Research Facility Nottingham Digestive Diseases CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

LGI Diet

HGI Diet

Arm Description

low glycemic index diet

High glycemic index diet

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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. .
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.
Blood insulin levels
To assess the differences in blood insulin levels between LGI and HGI diet groups in participants with NAFLD using radioimmunoassay methods .
Blood insulin levels
To assess the differences in blood insulin levels between LGI and HGI diet groups in participants with NAFLD using radioimmunoassay methods .
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)
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)
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.
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.
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).
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).
Plasma Short Chain Fatty Acids (SCFAs)
To investigate the differences in plasma SCFAs between LGI and HGI diet groups in participants with NAFLD.
Plasma Short Chain Fatty Acids (SCFAs)
To investigate the differences in plasma SCFAs between LGI and HGI diet groups in participants with NAFLD.
Anthropometric measurements
Weight in kg, Height in meters will be combined to report BMI kg/m^2 or each study arm
Anthropometric measurements
Weight in kg, Height in meters will be combined to report BMI kg/m^2 or each study arm
Body composition Fat Mass
Bio-electrical Impedance analysis (BIA) will be used to assess the body composition of fat mass %.
Body composition Fat Mass
Bio-electrical Impedance analysis (BIA) will be used to assess the body composition of fat mass %.
Body composition Muscle Mass
Bio-electrical Impedance analysis (BIA) will be used to assess the body composition of muscle mass %.
Body composition Muscle Mass
Bio-electrical Impedance analysis (BIA) will be used to assess the body composition of muscle mass %.
Body composition Water Content
Bio-electrical Impedance analysis (BIA) will be used to assess the body composition of water content %.
Body composition Water Content
Bio-electrical Impedance analysis (BIA) will be used to assess the body composition of water content %.
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.

Full Information

First Posted
April 20, 2020
Last Updated
September 28, 2021
Sponsor
University of Nottingham
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1. Study Identification

Unique Protocol Identification Number
NCT04415632
Brief Title
Low GI Diet Effects on Non-Alcoholic Fatty Liver Disease
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 10, 2020 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatty Liver, Nutritional and Metabolic Disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
NIHR Nottingham Clinical Research Facility Nottingham Digestive Diseases Centre
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amina Al-Awadi
Phone
+44 (0)115 823 1073
Email
Amina.Alawadi@nuh.nhs.uk
First Name & Middle Initial & Last Name & Degree
Guruprasad Aithal, Professor

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Within a five-year timeframe, the final anonymized trial data will be uploaded to the https://rdmc.nottingham.ac.uk public repository after consistency and quality have been verified by the project team and publication of the results. Data from this trial are intended to be presented at local and international conferences including those attended by clinicians and dietitians and will also be used as part of a Philosophy Doctorate thesis. Publications will be in peer reviewed journals. No participant will be identified in any of these publications.
IPD Sharing Time Frame
within five years time-frame
IPD Sharing Access Criteria
Public repository. presented at local and international conferences. part of a Philosophy Doctorate thesis
IPD Sharing URL
https://rdmc.nottingham.ac.uk
Citations:
PubMed Identifier
34620653
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.
Results Reference
derived

Learn more about this trial

Low GI Diet Effects on Non-Alcoholic Fatty Liver Disease

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