Fatty LiverLGI-NAFLDNCT04415632
Low GI Diet Effects on Non-Alcoholic Fatty Liver Disease
A study testing low glycemic index diet and High glycemic index diet in people with Fatty Liver and Nutritional and Metabolic Disease, run by University of Nottingham at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fatty Liver, Nutritional and Metabolic Disease
- What is being tested?
- low glycemic index diet and High glycemic index diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Dec 2020to 18 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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™.
Who cannot join
- • 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.
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site
NIHR Nottingham Clinical Research Facility Nottingham Digestive Diseases Centre
Nottingham, Nottinghamshire, NG7 2UH
About this study
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)
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).
Read the detailed description
Following the screening phase and standardisation week, each participant will experience two, 2-week intervention phases, with a 4-week washout period between interventions. Before and after each intervention period they will attend the Imaging Centre (Sir Peter Mansfield Imaging Centre) for MRI scan measurements and then will attend the Biomedical Research Centre for FibroScan, and blood and stool samples collection. During each intervention phase each participant will be required to consume all the food that has been provided, fill in dietary compliance sheets and complete Visual Analogue Scales (VAS) relating to subjective appetite ratings.
Design of the dietary interventions Energy expenditure will be estimated for each participant using the individual's basal metabolic rate calculated from Henry-modified Schofield formula and multiplied by an activity factor based on the IPAQ score physical activity levels. A menu, consisting of meals for 3 days personalised for energy requirement, will be devised (these meals are repeated over 2 weeks) by adjusting a template according to their estimated energy requirement in order to minimise weight change during the intervention phase. The diet consists of normal food closely resembling that described by Bawden et al study. A diet template of 2000 kcal/day with energy proportions distributed as 55% from carbohydrates, 15% from protein and 30% from fat are designed and food quantities will be modified to supply the energy requirements for each participant. Three-day cycle menu plans are designed for each diet (LGI/ HGI). Table 1 shows example template menus for both HGI (a) and LGI (b) diets.
The GI values of commercial food items are generated from that reported by Henry et al, as well as Nutritics software databases (Nutritics). The dietary GI of the menu is calculated from GI proportional contribution to total carbohydrate using the equation: GI=∑(Cfood/Ctotal) × GIfood; where Cfood is the amount of carbohydrate contained in each digested food (g), Ctotal is the total carbohydrate in the meal and is the reported GI of the food. The GL of the diet is calculated based on the dietary GI and the amount of carbohydrate provided (the same in both diets) using the following equation: GL=(GIfood × Cfood)/100; where GI is the GI of each digested food and food is the amount of carbohydrate in the food. Food composition analysis and evaluation were performed using Nutritics software (Nutritics, Dublin, Ireland, 2018).
Participants will be provided with the food at the start of each 2-week diet period and will be clearly instructed on safe food storage and reheating. They will be required to complete dietary compliance sheet on a daily basis. Instructions on dietary compliance will be given at each study period and the dietary compliance records will be reviewed regularly during the intervention to assess their compliance. For the first 1 week prior to the intervention (1-week standardisation), and during the 4-week wash-out period, participants will be asked to avoid eating probiotics, yoghurt and cultured milk drink; if any, to standardise their gut microbiota and avoid any carry-over effects as shown in previous studies.Meal-timing will be standardised among all participants as much as possible during the intervention as well as during the standardisation period.
- Conditions
- Fatty Liver, Nutritional and Metabolic Disease
- Being tested
- low glycemic index diet, High glycemic index diet
- Medical subject headings
- Fatty Liver, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low glycemic index dietOther
Also called LGI
- 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 dietOther
Also called HGI
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.
| Study group | Role | What they receive |
|---|---|---|
| LGI Diet | Experimental | low glycemic index diet Receives: Other: low glycemic index diet |
| HGI Diet | Other | High glycemic index diet Receives: Other: High glycemic index diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Liver Fat Content From Baseline to End of Each 2-Week Dietary Intervention
Change in liver fat content (%) from baseline to the end of each 2-week dietary intervention period (LGI diet and HGI diet) in participants with NAFLD. Liver fat content was measured using magnetic resonance spectroscopy. Values represent liver fat content at 2 weeks minus liver fat content at baseline. Lower values indicate lower liver fat content and may reflect improvement in hepatic steatosis.
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Measured: Baseline and end of each 2-week dietary intervention period
Secondary outcomes (10)
Change in Gut Microbiome Alpha Diversity After 2 Weeks of LGI and HGI Diets
Change in gut microbiome alpha diversity from baseline to the end of each 2-week dietary intervention period (LGI diet and HGI diet), assessed by 16S rRNA gene sequencing in participants with NAFLD. Higher values indicate greater microbial alpha diversity. Values represent the change from baseline to the end of the intervention period.
Measured: Baseline and end of each 2-week dietary intervention period
Change in Gut Microbiome Beta Diversity From Baseline to End of Each 2-Week Dietary Intervention
Change in gut microbiome beta diversity from baseline to the end of each 2-week dietary intervention period (LGI diet and HGI diet), assessed by 16S rRNA gene sequencing using UniFrac distance. Beta diversity measures differences in microbial community composition between samples. Lower UniFrac distance values indicate greater similarity between microbial communities, whereas higher values indicate greater dissimilarity. UniFrac distance ranges from 0 to 1, where 0 indicates identical communities and 1 indicates completely distinct communities. Values represent the change from baseline to the end of each intervention period.
Measured: Baseline and end of each 2-week dietary intervention period
Change in Blood Glucose Level From Baseline to End of 2-Week Dietary Intervention
Change in fasting blood glucose concentration from baseline to the end of each 2-week dietary intervention period (LGI diet and HGI diet), measured using a Horiba automated analyser. Values represent blood glucose at 2 weeks minus blood glucose at baseline. Higher values indicate an increase in blood glucose concentration, whereas lower or negative values indicate a decrease in blood glucose concentration.
Measured: Baseline and end of each 2-week dietary intervention period
Blood Insulin Change in Fasting Insulin Concentration From Baseline to End of Each 2-Week Dietary Intervention
Change in fasting insulin concentration from baseline to the end of each 2-week dietary intervention period (LGI diet and HGI diet). Values represent insulin concentration at 2 weeks minus insulin concentration at baseline. Lower values indicate lower circulating insulin concentrations.
Measured: Baseline and end of each 2-week dietary intervention period
Change in Liver Function Biomarkers From Baseline to End of Each 2-Week Dietary Intervention
Change in liver function biomarkers from baseline to the end of each 2-week dietary intervention period. Values represent the biomarker concentration at 2 weeks minus the concentration at baseline 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)
Measured: 2 Baseline and end of each 2-week dietary intervention period Show more lines
Change in Blood Lipids Concentration From Baseline to End of Each 2-Week Dietary Intervention Show More Lines
Change in fasting blood lipids concentration from baseline to the end of each 2-week dietary intervention period. Values represent triglyceride concentration at 2 weeks minus triglyceride concentration at baseline. The blood lipids biomarkers to be assessed are Total Cholesterol, High-density lipoprotein, low-density lipoprotein, Triglycerides.
Measured: Baseline and end of each 2-week dietary intervention period
Change in Gut Hormones Concentration From Baseline to End of Each 2-Week Dietary Intervention
Change in gut hormones concentration from baseline to the end of each 2-week dietary intervention period. Values represent GLP-1 concentration at 2 weeks minus GLP-1 concentration at baseline.using radioimmunoassay (RIA) or Sandwich ELISA methods. The blood gut hormones to be assessed were Leptin, Ghrelin,, GLP-1 (Glucagon-like peptide 1).
Measured: Baseline and end of each 2-week dietary intervention period
Change in Plasma Short-Chain Fatty Acid Concentrations From Baseline to End of Each 2-Week Dietary Intervention
Change in plasma short-chain fatty acid (SCFA) concentrations from baseline to the end of each 2-week dietary intervention period (LGI diet and HGI diet) in participants with NAFLD. Plasma SCFAs (including acetic acid, butyric acid, and valeric acid) were measured in fasting blood samples. Values represent the concentration at the end of the intervention period minus the concentration at baseline. Higher values indicate higher circulating SCFA concentrations.
Measured: Baseline and end of each 2-week dietary intervention period
Change in Body Weight From Baseline to End of Each 2-Week Dietary Intervention
Change in body weight from baseline to the end of each 2-week dietary intervention period (LGI diet and HGI diet) in participants with NAFLD. Body weight was measured in kilograms using calibrated scales. Values represent body weight at the end of the intervention period minus body weight at baseline. Negative values indicate weight loss, whereas positive values indicate weight gain.
Measured: Baseline and end of each 2-week dietary intervention period
Change in Composite Appetite Sensations (CAS) Score From Baseline to End of Each 2-Week Dietary Intervention
Composite Appetite Sensations (CAS) score was derived from Visual Analogue Scale (VAS) assessments of appetite. Participants rated hunger, satisfaction, fullness, desire to eat, and prospective food consumption on 10-cm (0-100 mm) visual analogue scales. The CAS score was calculated as:
2
3 [Hunger + (100 - Satisfaction) + (100 - Fullness) + Desire to Eat + Prospective Food Consumption] / 5 4
5 CAS scores range from 0 to 100 mm, with higher scores indicating greater overall appetite and lower scores indicating lower appetite. Values represent the change from baseline to the end of each 2-week dietary intervention period.
Measured: Baseline and end of each 2-week dietary intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start10 Dec 2020
- Primary completion18 Oct 2022
- Study completion18 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fatty LiverStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guru Aithal, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415632
- Sponsor's protocol ID
- 19042
- Other IDs
- 262245, 19/EM/0291
- Acronym
- LGI-NAFLD
- Status last verified
- Dec 2022
- First submitted
- 20 Apr 2020
- Last updated
- 5 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Al-Awadi AA, Grove JI, Bawden S, Vijay A, Valdes AM, Gowland P, Taylor MA, Aithal GP. The effect of a two-week low glycaemic index, higher fibre diet versus high glycaemic index diet on body composition, ectopic lipids, inflammatory biomarkers, gastrointestinal hormones and gut microbiota in metabolic dysfunction-associated steatotic liver disease (MASLD): A pilot randomized cross-over study. Clin Nutr ESPEN. 2026 Jun;73:103306. doi: 10.1016/j.clnesp.2026.103306. Epub 2026 Apr 25.
PubMed 42044842Al-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.
PubMed 34620653
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04415632
- Acronym / sponsor ID
- LGI-NAFLD / 19042
- Conditions
- Fatty Liver, Nutritional and Metabolic Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 18 Oct 2022 (actual)
- Study completion
- 18 Oct 2022 (actual)
- First posted
- 4 Jun 2020 (actual)
- Results
- Posted 5 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Following the screening phase and standardisation week, each participant will experience two, 2-week intervention phases, with a 4-week washout period between interventions. Before and after each intervention period they will attend the Imaging Centre (Sir Peter Mansfield Imaging Centre) for MRI scan measurements and then will attend the Biomedical Research Centre for FibroScan, and blood and stool samples collection. During each intervention phase each participant will be required to consume all the food that has been provided, fill in dietary compliance sheets and complete Visual Analogue Scales (VAS) relating to subjective appetite ratings.
Design of the dietary interventions Energy expenditure will be estimated for each participant using the individual's basal metabolic rate calculated from Henry-modified Schofield formula and multiplied by an activity factor based on the IPAQ score physical activity levels. A menu, consisting of meals for 3 days personalised for energy requirement, will be devised (these meals are repeated over 2 weeks) by adjusting a template according to their estimated energy requirement in order to minimise weight change during the intervention phase. The diet consists of normal food closely resembling that described by Bawden et al study. A diet template of 2000 kcal/day with energy proportions distributed as 55% from carbohydrates, 15% from protein and 30% from fat are designed and food quantities will be modified to supply the energy requirements for each participant. Three-day cycle menu plans are designed for each diet (LGI/ HGI). Table 1 shows example template menus for both HGI (a) and LGI (b) diets.
The GI values of commercial food items are generated from that reported by Henry et al, as well as Nutritics software databases (Nutritics). The dietary GI of the menu is calculated from GI proportional contribution to total carbohydrate using the equation: GI=∑(Cfood/Ctotal) × GIfood; where Cfood is the amount of carbohydrate contained in each digested food (g), Ctotal is the total carbohydrate in the meal and is the reported GI of the food. The GL of the diet is calculated based on the dietary GI and the amount of carbohydrate provided (the same in both diets) using the following equation: GL=(GIfood × Cfood)/100; where GI is the GI of each digested food and food is the amount of carbohydrate in the food. Food composition analysis and evaluation were performed using Nutritics software (Nutritics, Dublin, Ireland, 2018).
Participants will be provided with the food at the start of each 2-week diet period and will be clearly instructed on safe food storage and reheating. They will be required to complete dietary compliance sheet on a daily basis. Instructions on dietary compliance will be given at each study period and the dietary compliance records will be reviewed regularly during the intervention to assess their compliance. For the first 1 week prior to the intervention (1-week standardisation), and during the 4-week wash-out period, participants will be asked to avoid eating probiotics, yoghurt and cultured milk drink; if any, to standardise their gut microbiota and avoid any carry-over effects as shown in previous studies.Meal-timing will be standardised among all participants as much as possible during the intervention as well as during the standardisation period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LGI Diet | Experimental | Other: low glycemic index dietlow glycemic index diet |
| HGI Diet | Other | Other: High glycemic index dietHigh glycemic index diet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- • Adult males and females aged from 18 to 65 years (balanced number).
Key exclusion criteria (10 listed)
- • Current smokers and excessive alcohol drinkers (> 14 units/week).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low glycemic index dietAlso: LGI• 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. | Other | LGI Diet |
| High glycemic index dietAlso: HGIThree-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. | Other | HGI Diet |
Primary outcome
Change in Liver Fat Content From Baseline to End of Each 2-Week Dietary Intervention
Time frame: Baseline and end of each 2-week dietary intervention period
Change in liver fat content (%) from baseline to the end of each 2-week dietary intervention period (LGI diet and HGI diet) in participants with NAFLD. Liver fat content was measured using magnetic resonance spectroscopy. Values represent liver fat content at 2 weeks minus liver fat content at baseline. Lower values indicate lower liver fat content and may reflect improvement in hepatic steatosis. Show more lines
10 secondary outcomes
Change in Gut Microbiome Alpha Diversity After 2 Weeks of LGI and HGI Diets
Time frame: Baseline and end of each 2-week dietary intervention period
Change in Gut Microbiome Beta Diversity From Baseline to End of Each 2-Week Dietary Intervention
Time frame: Baseline and end of each 2-week dietary intervention period
Change in Blood Glucose Level From Baseline to End of 2-Week Dietary Intervention
Time frame: Baseline and end of each 2-week dietary intervention period
Blood Insulin Change in Fasting Insulin Concentration From Baseline to End of Each 2-Week Dietary Intervention
Time frame: Baseline and end of each 2-week dietary intervention period
Change in Liver Function Biomarkers From Baseline to End of Each 2-Week Dietary Intervention
Time frame: 2 Baseline and end of each 2-week dietary intervention period Show more lines
Change in Blood Lipids Concentration From Baseline to End of Each 2-Week Dietary Intervention Show More Lines
Time frame: Baseline and end of each 2-week dietary intervention period
Change in Gut Hormones Concentration From Baseline to End of Each 2-Week Dietary Intervention
Time frame: Baseline and end of each 2-week dietary intervention period
Change in Plasma Short-Chain Fatty Acid Concentrations From Baseline to End of Each 2-Week Dietary Intervention
Time frame: Baseline and end of each 2-week dietary intervention period
Change in Body Weight From Baseline to End of Each 2-Week Dietary Intervention
Time frame: Baseline and end of each 2-week dietary intervention period
Change in Composite Appetite Sensations (CAS) Score From Baseline to End of Each 2-Week Dietary Intervention
Time frame: Baseline and end of each 2-week dietary intervention period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42044842Al-Awadi AA, Grove JI, Bawden S, Vijay A, Valdes AM, Gowland P, Taylor MA, Aithal GP. The effect of a two-week low glycaemic index, higher fibre diet versus high glycaemic index diet on body composition, ectopic lipids, inflammatory biomarkers, gastrointestinal hormones and gut microbiota in metabolic dysfunction-associated steatotic liver disease (MASLD): A pilot randomized cross-over study. Clin Nutr ESPEN. 2026 Jun;73:103306. doi: 10.1016/j.clnesp.2026.103306. Epub 2026 Apr 25.
- Derived from this study: PubMed 34620653Al-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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guru Aithal, PhD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low glycemic index diet and High glycemic index diet in people with Fatty Liver and Nutritional and Metabolic Disease, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Liver Fat Content From Baseline to End of Each 2-Week Dietary Intervention (time frame: Baseline and end of each 2-week dietary intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04415632, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.