Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05259475 |
| Other study ID # |
2021/00339 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 20, 2021 |
| Est. completion date |
July 31, 2022 |
Study information
| Verified date |
September 2023 |
| Source |
Singapore Institute for Clinical Sciences |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
The study will consist of a 12-week, parallel three-arm, single-centre, randomized controlled
trial (RCT); 90 women of Chinese ethnicity matched for age and BMI will be randomized to one
of 3 study arms in 1:1:1 ratio by Blockrand R software at Week -1 visit. The study arms are:
(1) Lifestyle advice alone, (2) Lifestyle advice with calorie-restricted diet-intervention,
and (3) Lifestyle advice with calorie-restricted diet-intervention inclusive of odd-chain
fatty acids (OCFA)-containing food product.
In all 3 study arms, the lifestyle advice on maintaining a healthy diet and regular exercise
(~180 mins/ week) will be compatible with recommendations by Health Promotion Board. The
participants in the control study arm (Lifestyle advice alone) will receive 1 session of diet
advice from the study dietician at the start of the study only. The dietitian will provide
dietary advice on the eating plans and instructions for completion of diet checklist.
In the "Diet Intervention (calorie-restricted multifactorial diet)" study arm (arm 2), a
moderate energy restriction (500-1000 kcal/day) will be prescribed to facilitate weight loss.
To facilitate compliance, participants in the diet-intervention arms will receive individual
diet consultations with the study dietitian during the study. Participants in both the
meal-based diet-intervention arms (arm 2 and arm 3) will be supplied with 2 main meals per
day as part of their daily diet, for 6 days a week. Additional food products may be supplied
for breakfast and snacks. The diet will be designed to be nutritionally replete, feasible,
and sustainable in the long-term. The diet will be based on whole grain-based products,
vegetables, legumes, extra virgin olive oil, fruits, almonds, salmon, and plant-based meat
analogues. Diet plans will be individualized and energy matched to enable any metabolic
differences between arms to be attributed to the macronutrient profiles of the diets, without
confounding by differences in weight loss between diet arms. Energy requirements will be
calculated by indirect calorimetry (Quark CPET, COSMED) with an activity factor.
Participants in the "OCFA meal-based diet-intervention" study arm (arm 3) will be provided
with a daily OCFA-containing food product, in addition to the lunch and dinner meals. Both
the participants in arm 2 and 3 will be receiving the same lunch and dinner meals.
Participants in both the meal-based diet-intervention arms (arm 2 and arm 3) will be told to
consume only low-fat dairy products (milk, yoghurt), avoid ruminant meat (beef, lamb), avoid
cheese, butter and butter-containing food products. Both diet-intervention arms will be told
to avoid sugar-sweetened beverages.
