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Effetti della dieta a basso indice glicemico sulla steatosi epatica non alcolica (LGI-NAFLD)

13 luglio 2026 aggiornato da: University of Nottingham

Effetti di una dieta isoenergetica a basso indice glicemico (IG) sull'accumulo di grasso nel fegato e sulla composizione del microbiota intestinale in pazienti con steatosi epatica non alcolica (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).

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

12

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Regno Unito
    • Nottinghamshire
      • Nottingham, Nottinghamshire, Regno Unito, NG7 2UH
        • NIHR Nottingham Clinical Research Facility Nottingham Digestive Diseases Centre

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: LGI Diet

low glycemic index diet
Altro: low glycemic index diet

• 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.

Altri nomi:
  • LGI
Altro: HGI Diet

High glycemic index diet
Altro: High glycemic index diet

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.

Altri nomi:
  • HGI

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Liver Fat Content From Baseline to End of Each 2-Week Dietary Intervention
Lasso di tempo: 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
Baseline and end of each 2-week dietary intervention period

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Gut Microbiome Alpha Diversity After 2 Weeks of LGI and HGI Diets
Lasso di tempo: Baseline and end of each 2-week dietary intervention period

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.
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
Lasso di tempo: Baseline and end of each 2-week dietary intervention period

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.
Baseline and end of each 2-week dietary intervention period
Change in Blood Glucose Level From Baseline to End of 2-Week Dietary Intervention
Lasso di tempo: Baseline and end of each 2-week dietary intervention period

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.
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
Lasso di tempo: Baseline and end of each 2-week dietary intervention period

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.
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
Lasso di tempo: 2 Baseline and end of each 2-week dietary intervention period Show more lines

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)
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
Lasso di tempo: Baseline and end of each 2-week dietary intervention period

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.
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
Lasso di tempo: Baseline and end of each 2-week dietary intervention period

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).
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
Lasso di tempo: Baseline and end of each 2-week dietary intervention period

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.
Baseline and end of each 2-week dietary intervention period
Change in Body Weight From Baseline to End of Each 2-Week Dietary Intervention
Lasso di tempo: Baseline and end of each 2-week dietary intervention period

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.
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
Lasso di tempo: Baseline and end of each 2-week dietary intervention period

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.
Baseline and end of each 2-week dietary intervention period

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Nottingham

Investigatori

  • Investigatore principale: Guru Aithal, PhD, University of Nottingham

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

10 dicembre 2020

Completamento primario (Effettivo)

18 ottobre 2022

Completamento dello studio (Effettivo)

18 ottobre 2022

Date di iscrizione allo studio

Primo inviato

20 aprile 2020

Primo inviato che soddisfa i criteri di controllo qualità

29 maggio 2020

Primo Inserito (Effettivo)

4 giugno 2020

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 luglio 2026

Ultimo verificato

1 dicembre 2022

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 19042
  • 262245 (Altro identificatore: IRAS)
  • 19/EM/0291 (Altro identificatore: REC)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Periodo di condivisione IPD

within five years time-frame

Criteri di accesso alla condivisione IPD

Public repository. presented at local and international conferences. part of a Philosophy Doctorate thesis

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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