Non-Alcoholic Fatty Liver DiseaseTANGONCT05259475
Ectopic Fat in Singaporean Women - the Culprit Leading to Gestational Diabetes, Metabolic Syndrome, and Type 2 Diabetes (TANGO Study)
A study testing Lifestyle Advice, Diet Intervention and OCFA Meal-Based Diet-Intervention in people with Non-Alcoholic Fatty Liver Disease, run by Institute for Human Development and Potential (IHDP), Singapore at 1 site in Singapore.
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… Read more about this study
- Who is it for?
- Ages 21 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Lifestyle Advice, Diet Intervention and OCFA Meal-Based Diet-Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSingapore
- Study dates
- 20 Aug 2021to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ectopic Fat in Singaporean Women - the Culprit Leading to Gestational Diabetes, Metabolic Syndrome, and Type 2 Diabetes
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.
Read more
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.
Read the detailed 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.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- Lifestyle Advice, Diet Intervention, OCFA Meal-Based Diet-Intervention
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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. Receives: Other: OCFA Meal-Based Diet-Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in liver fat content.
Assessed by Fibroscan CAP (Controlled Attenuation Parameter) score.
Measured: Screening, and Week 12
Secondary outcomes (8)
Change in liver fat, intramyocellular lipid content (IMCL), and abdominal fat compartments.
MRI/MRS will be used to measure the amount of fat in the liver, abdomen and leg of the participants.
Measured: Week 0, and 12
Change in insulin sensitivity and Fatty Liver Indexes (FLI).
Fatty Liver Indexes (FLI) will be calculated based on blood measurements of liver enzymes, lipids, and insulin.
Measured: Week 0, 4, 8 and 12
Change in sleep quality as assessed by the OURA Ring Sleep Score.
Participants will be issued a wearable device to capture durations of deep sleep, rapid eye movement (REM) sleep, light sleep, and nightly heart rate. Sleep Score ranges from 0-100, where a higher score reflects better sleep outcome.
Measured: Week 0, and 12
Change in daily physical activity levels as assessed by the OURA Ring Activity Score.
Participants will be issued a wearable device to capture durations of activity, inactivity and rest. Activity Score ranges from 0-100, where a higher score reflects better balance between activity and rest.
Measured: Week 0, and 12
Change in quality of life.
Assessed by the 36-Item Short Form Survey (SF-36).
Measured: Week 0, 4, 8 and 12
Change in anxiety (if any).
Assessed by State-Trait Anxiety Inventory (STAI).
Measured: Week 0, 4, 8 and 12
Change in depression (if any).
Assessed by Beck Depression Inventory-II (BDI-II).
Measured: Week 0, 4, 8 and 12
Change in the composition of gut microbiota from baseline due to the diet intervention.
Assessed using gut metagenome and metatranscriptome profiling.
Measured: Week 0, 2, 4, 8, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start20 Aug 2021
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Human Development and Potential (IHDP), Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Wilmar International Limited, SATA CommHealth (Singapore), National University Polyclinics, Singapore, National University of Singapore
- Responsible party
- Principal investigator, Johan Eriksson, Institute for Human Development and Potential (IHDP), Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05259475
- Sponsor's protocol ID
- 2021/00339
- Acronym
- TANGO
- Status last verified
- Sep 2023
- First submitted
- 12 Jan 2022
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40777170Salamanca-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.
PubMed 40697557Chooi 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.
PubMed 38035997
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ectopic Fat in Singaporean Women - the Culprit Leading to Gestational Diabetes, Metabolic Syndrome, and Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05259475
- Acronym / sponsor ID
- TANGO / 2021/00339
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Institute for Human Development and Potential (IHDP), SingaporeUniversity, hospital or other
- Collaborators
- Wilmar International Limited, SATA CommHealth (Singapore), National University Polyclinics, Singapore, National University of Singapore
- Study start
- 20 Aug 2021 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 28 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lifestyle advice alone | Other | Other: Lifestyle AdviceThe 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). |
| Diet Intervention | Experimental | Other: Diet InterventionParticipants 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. |
| OCFA Meal-Based Diet-Intervention | Experimental | Other: OCFA Meal-Based Diet-InterventionParticipants 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. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle AdviceMaintain a weekly healthy diet and regular exercise. | Other | Lifestyle advice alone |
| Diet InterventionCalorie-restricted meals (lunch and dinner) | Other | Diet Intervention |
| OCFA Meal-Based Diet-InterventionOCFA-containing food product | Other | OCFA Meal-Based Diet-Intervention |
Primary outcome
Change in liver fat content.
Time frame: Screening, and Week 12
Assessed by Fibroscan CAP (Controlled Attenuation Parameter) score.
8 secondary outcomes
Change in liver fat, intramyocellular lipid content (IMCL), and abdominal fat compartments.
Time frame: Week 0, and 12
Change in insulin sensitivity and Fatty Liver Indexes (FLI).
Time frame: Week 0, 4, 8 and 12
Change in sleep quality as assessed by the OURA Ring Sleep Score.
Time frame: Week 0, and 12
Change in daily physical activity levels as assessed by the OURA Ring Activity Score.
Time frame: Week 0, and 12
Change in quality of life.
Time frame: Week 0, 4, 8 and 12
Change in anxiety (if any).
Time frame: Week 0, 4, 8 and 12
Change in depression (if any).
Time frame: Week 0, 4, 8 and 12
Change in the composition of gut microbiota from baseline due to the diet intervention.
Time frame: Week 0, 2, 4, 8, and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Derived from this study: PubMed 40777170Chooi 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.
- Derived from this study: PubMed 40697557Salamanca-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.
- Derived from this study: PubMed 38035997Chooi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Advice, Diet Intervention and OCFA Meal-Based Diet-Intervention in people with Non-Alcoholic Fatty Liver Disease, run by Institute for Human Development and Potential (IHDP), Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in liver fat content. (time frame: Screening, and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05259475, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023; AzTrials last refreshed its copy on 8 Nov 2026.