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

NCT05259475 | Completed

• 1 other identifier: 2021/00339
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-Alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• Change in liver fat content.

  Assessed by Fibroscan CAP (Controlled Attenuation Parameter) score.

  Screening, and Week 12

Secondary Outcomes (8)

• Change in liver fat, intramyocellular lipid content (IMCL), and abdominal fat compartments.

  Week 0, and 12

• Change in insulin sensitivity and Fatty Liver Indexes (FLI).

  Week 0, 4, 8 and 12

• Change in sleep quality as assessed by the OURA Ring Sleep Score.

  Week 0, and 12

• Change in daily physical activity levels as assessed by the OURA Ring Activity Score.

  Week 0, and 12

• Change in quality of life.

  Week 0, 4, 8 and 12

Study Arms (3)

Lifestyle advice alone

OTHER

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).

Other: Lifestyle Advice

Diet Intervention

EXPERIMENTAL

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.

Other: Diet Intervention

OCFA Meal-Based Diet-Intervention

EXPERIMENTAL

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.

Other: OCFA Meal-Based Diet-Intervention

Interventions

Lifestyle Advice OTHER

Maintain a weekly healthy diet and regular exercise.

Lifestyle advice alone

Diet Intervention OTHER

Calorie-restricted meals (lunch and dinner)

Diet Intervention

OCFA Meal-Based Diet-Intervention OTHER

OCFA-containing food product

OCFA Meal-Based Diet-Intervention

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute for Human Development and Potential (IHDP), Singapore: lead
• Wilmar International Limited: collaborator
• SATA CommHealth (Singapore): collaborator
• National University Polyclinics, Singapore: collaborator
• National University of Singapore: collaborator

Study Sites (1)

Human Development Research Centre (Hdrc)

Singapore, 117597, Singapore

Location

Related Publications (3)

• Chooi YC, Magkos F, Yaligar J, Michael N, Sadananthan SA, Kway YM, Velan SS, Lim KJ, Lai X, Wong LH, Chong YS, Loo EXL, Eriksson JG. Adherence to a "MediterrAsian" diet is associated with weight loss-independent improvements in liver fat and lipid profile, but not glucoregulation or inflammation: secondary analysis of a randomized controlled trial. Front Nutr. 2025 Jul 24;12:1623612. doi: 10.3389/fnut.2025.1623612. eCollection 2025.

  PMID: 40777170 DERIVED

• Salamanca-Sanabria A, Chooi YC, Loo EXL, Lai X, Volchanskaya VSB, Chong YS, Eriksson JG. Potential effects of Asian-adapted Mediterranean diet in depression and anxiety among women with metabolic dysfunction-associated steatotic liver disease: a secondary analysis. Front Nutr. 2025 Jul 8;12:1589412. doi: 10.3389/fnut.2025.1589412. eCollection 2025.

  PMID: 40697557 DERIVED

• Chooi YC, Zhang QA, Magkos F, Ng M, Michael N, Wu X, Volchanskaya VSB, Lai X, Wanjaya ER, Elejalde U, Goh CC, Yap CPL, Wong LH, Lim KJ, Velan SS, Yaligar J, Muthiah MD, Chong YS, Loo EXL, Eriksson JG; TANGO Study Group. Effect of an Asian-adapted Mediterranean diet and pentadecanoic acid on fatty liver disease: the TANGO randomized controlled trial. Am J Clin Nutr. 2024 Mar;119(3):788-799. doi: 10.1016/j.ajcnut.2023.11.013. Epub 2023 Nov 29.

  PMID: 38035997 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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).
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director & Programme Director (Human Development)

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: February 28, 2022
• Study Start: August 20, 2021
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: September 25, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)