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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-20

Study Completion Date

2022-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Non-Alcoholic Fatty Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Both study team and the subjects receiving diet intervention will be blinded on the allocation to food product with or without odd-chain fatty acids (OCFA).

Study Groups

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Lifestyle advice alone

The participants in "Lifestyle advice alone" arm (study control) will receive 1 session of diet advice from the study dietitian at the start of the study only. The dietitian will provide dietary advice on the eating plans and instructions for completion of diet checklist. The lifestyle advice on maintaining a healthy diet and regular exercise (\~180 mins/ week) will be compatible with recommendations by the Health Promotion Board (Singapore).

Group Type OTHER

Lifestyle Advice

Intervention Type OTHER

Maintain a weekly healthy diet and regular exercise.

Diet Intervention

Participants will be supplied with 2 main meals per day as part of their daily diet, for 6 days a week. This diet is prescribed as a moderate energy restriction (500-1000 kcal/day) to facilitate weight loss. Additional food products are supplied for breakfast and snacks. Participants will receive individual diet consultations with the study dietitian during the study. Participants are told to consume only low-fat dairy products (milk, yoghurt), and avoid ruminant meat (beef, lamb), cheese, butter, butter-containing food products, and sugar-sweetened beverages.

Group Type EXPERIMENTAL

Diet Intervention

Intervention Type OTHER

Calorie-restricted meals (lunch and dinner)

OCFA Meal-Based Diet-Intervention

Participants in the "OCFA meal-based diet-intervention" arm will be provided with OCFA-containing food product, in addition to the lunch and dinner meals (6 days a week) given in the "Diet Intervention" arm. Participants will receive individual diet consultations with the study dietitian during the study. Participants are told to consume only low-fat dairy products (milk, yoghurt), and avoid ruminant meat (beef, lamb), cheese, butter, butter-containing food products, and sugar-sweetened beverages.

Group Type EXPERIMENTAL

OCFA Meal-Based Diet-Intervention

Intervention Type OTHER

OCFA-containing food product

Interventions

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Lifestyle Advice

Maintain a weekly healthy diet and regular exercise.

Intervention Type OTHER

Diet Intervention

Calorie-restricted meals (lunch and dinner)

Intervention Type OTHER

OCFA Meal-Based Diet-Intervention

OCFA-containing food product

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Chinese ethnicity
* Females, Age 21-45 years
* Body mass index (BMI) 23-35 kg/m2
* Not planning to conceive within 6 months from enrolment
* Elevated liver fat content (FibroScan CAP score \>=268 dB/m)

Exclusion Criteria

* Do not intend to reside in Singapore for the next 6 months
* Delivered within the last 6 months
* Currently pregnant or breastfeeding
* Having more than 5% weight loss over the past 3 months
* Receiving antibiotics or suffering from diarrhoea over the last 3 months
* Not willing to adhere to lifestyle intervention required by study
* Following special diets or having intentional dietary restrictions (e.g. vegetarians/vegans/ketogenic diet)
* Having contraindications for MRI e.g. metallic implants such as cardiac pacemaker
* Having alcohol consumption on more than 4 days per week with 6 or more alcoholic drinks per week
* Current and/or history of diabetes mellitus, other than GDM (Gestational Diabetes Mellitus)
* Having chronic medical conditions such as cancer, severe gastrointestinal disorders, infectious diseases such as hepatitis and severe mental disorders
* Having uncontrolled hypertension (\> 150/90 mmHg)
* Having any medication and/or supplements which may interfere with study results
* Having allergies or intolerances to any common food ingredients including eggs, fish, milk, sesame, mustard, sulphites, peanuts and tree nuts, shellfish, soy, wheat, gluten, cereal, fruits, dairy products, meat, vegetable, sugar and sweetener, food colourings or flavourings, etc.

Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes