Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Efeitos da dieta de baixo IG na doença hepática gordurosa não alcoólica (LGI-NAFLD)

13 de julho de 2026 atualizado por: University of Nottingham

Efeitos de uma dieta isoenergética de baixo índice glicêmico (IG) no acúmulo de gordura hepática e na composição da microbiota intestinal em pacientes com doença hepática gordurosa não alcoólica (DHGNA)

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).

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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 de estudo

Intervencional

Inscrição (Real)

12

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Reino Unido
    • Nottinghamshire
      • Nottingham, Nottinghamshire, Reino Unido, NG7 2UH
        • NIHR Nottingham Clinical Research Facility Nottingham Digestive Diseases Centre

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 65 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Outro
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição cruzada
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: LGI Diet

low glycemic index diet
Outro: 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.

Outros nomes:
  • LGI
Outro: HGI Diet

High glycemic index diet
Outro: 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.

Outros nomes:
  • HGI

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Liver Fat Content From Baseline to End of Each 2-Week Dietary Intervention
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in Gut Microbiome Alpha Diversity After 2 Weeks of LGI and HGI Diets
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of Nottingham

Investigadores

  • Investigador principal: Guru Aithal, PhD, University of Nottingham

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

10 de dezembro de 2020

Conclusão Primária (Real)

18 de outubro de 2022

Conclusão do estudo (Real)

18 de outubro de 2022

Datas de inscrição no estudo

Enviado pela primeira vez

20 de abril de 2020

Enviado pela primeira vez que atendeu aos critérios de CQ

29 de maio de 2020

Primeira postagem (Real)

4 de junho de 2020

Atualizações de registro de estudo

Última Atualização Postada (Real)

5 de outubro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

13 de julho de 2026

Última verificação

1 de dezembro de 2022

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 19042
  • 262245 (Outro identificador: IRAS)
  • 19/EM/0291 (Outro identificador: REC)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano 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.

Prazo de Compartilhamento de IPD

within five years time-frame

Critérios de acesso de compartilhamento IPD

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

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CIF

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever