CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 90 enrolled
Drug / intervention
Lifestyle Advice +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05259475
NCT05259475N/ACompleted

Ectopic Fat in Singaporean Women - the Culprit Leading to Gestational Diabetes, Metabolic Syndrome, and Type 2 Diabetes

Institute for Human Development and Potential (IHDP), Singapore·interventional·Posted Feb 28, 2022·Updated Sep 25, 2023

In Brief

A clinical study evaluating Lifestyle Advice, Diet Intervention, and 1 other intervention for Non-Alcoholic Fatty Liver Disease. Completed, enrolled 90 participants across 1 site.

Detailed Summary

Ectopic fat is the accumulation of adipose tissue in anatomical sites not classically associated with fat storage - for example, in the liver and skeletal muscles. Excessive fat accumulation in liver cells, often diagnosed as non-alcoholic fatty liver disease (NAFLD), is a precursor to a wide range of liver conditions and metabolic disorders. The usual standard of care for NAFLD is to advise weight loss through controlled diet and physical activity, but the outcome of weight management and treatment of NAFLD is highly variable. Diet interventions - such as the Mediterranean, ketogenic, paleo, and high-protein-low-carbohydrate diets - have shown varied benefits in the management of NAFLD. However, food-based interventions must align with cultural and regional preferences in food to succeed in making the modifications part of the habitual diet. A recent diet intervention study (Della Pepa et al., 2020) highlighted that the components of a diet, rather than its caloric content, play a greater role in achieving healthier outcomes. In this study, a multifactorial diet intervention using locally sourced and produced meals will be implemented with the aim of reducing elevated liver fat content in healthy women diagnosed with NAFLD. The study will also evaluate the effects of the proposed diet on the participants' metabolic health and describe potential changes in their gut microbiome signatures (via frequent stool samples). The dysregulation of the gut microbiota has been linked to the development of NAFLD and it is known that the composition of the gut microbiota could be modified by dietary intake. This study will investigate the association of gut microbiome signatures with elevated liver fat in Asian women and test whether the dietary intervention will modify their gut microbiota. Finally, ectopic fat in the liver is a highly prevalent condition worldwide but the cut-off values for NAFLD has been largely derived from studies performed in Western populations. This study seeks to cross examine the diagnostic ranges in various clinical assessments of NAFLD that commonly involve ultrasound spectroscopy (Fibroscan), fatty liver indexes (FLI) and magnetic resonance spectroscopy (MRS). This effort seeks to derive appropriate cut-off values for NAFLD in Singaporean-Chinese women.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSingapore

Timeline

N/ACompletedFinished
20222023202420252026
First PostedFeb 28, 2022
Enrollment StartAug 20, 2021
Primary CompletionJul 31, 2022
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 4.3 years ago

Interventions

Lifestyle Adviceother

Maintain a weekly healthy diet and regular exercise.

Diet Interventionother

Calorie-restricted meals (lunch and dinner)

OCFA Meal-Based Diet-Interventionother

OCFA-containing food product