Fatty Liver, NonalcoholicaMedNCT06321211
Development of a Novel Asian Mediterranean Diet and Its Acceptability in NAFLD
An observational study of Fatty Liver, Nonalcoholic, run by Singapore Institute of Technology at 1 site in Singapore.
Trial summary
The goal of this pre-intervention study is test the acceptability of Asian version of the Mediterranean diet to NAFLD patients. The main question[s] it aims to answer are: 1. Whether Asian version of the Mediterranean diet that retains the nutritional composition and can be developed by mapping the components of the… Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Fatty Liver, Nonalcoholic
- How many people
- 30 participants
- Where
- 1 siteSingapore
- Study dates
- 15 Apr 2024to 30 Oct 2025
- Phase
- Observational
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: We plan to recruit adults diagnosed with NAFLD (outpatients) from the Department of Hepatology in Singapore General Hospital.
Who may be able to join
- Diagnosis of NAFLD, as determined clinically by imaging evidence of hepatic steatosis on ultrasound/CT/MRI
Who cannot join
- Secondary causes of NAFLD (e.g. medication-induced)
- Unstable body weight (variation >5% within the preceding 3 months)
- Current use of weight loss medications
- Other liver diseases (viral hepatitis, auto-immune or cholestatic liver disease, Wilson's disease, hemochromatosis, alpha-1 anti-trypsin deficiency)
- Unstable diabetes (HbA1c >8.5%)
- Renal failure
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- Inability to provide informed consent
- Pregnancy and lactation
- Problems with tasting and smelling
- Food allergy/intolerances/restrictions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Novel Asian Mediterranean Diet and Its Acceptability in Non- Alcoholic Fatty Liver Disease (NAFLD)- a Pre-intervention Study
The goal of this pre-intervention study is test the acceptability of Asian version of the Mediterranean diet to NAFLD patients.
The main question[s] it aims to answer are:
- Whether Asian version of the Mediterranean diet that retains the nutritional composition and can be developed by mapping the components of the Mediterranean diet and finding substitute ingredients commonly eaten in Southeast Asia.
- Whether the 4-week menu cycle of newly developed novel Asian Mediterranean diet is acceptable among Singaporean local population.
Participants will participate in taste test sessions to find out if the Asian Mediterranean diet meals are acceptable to people with NAFLD.
Read the detailed description
Numerous studies have shown that Mediterranean diet decrease the risk of cardiovascular disease, metabolic syndrome, cancer and overall mortality characterized by being low in saturated fats and animal protein, high in antioxidants, fibre and monounsaturated fatty acids, and with an adequate omega-3 to omega-6 fatty acid balance.
Recent studies have proved that adherence to a Mediterranean diet is beneficial for non-alcoholic fatty liver disease (NAFLD) as it provides antioxidants and anti-inflammatory nutrients that slows the development of hepatic steatosis.
However, adhering to the Mediterranean diet can be difficult for people of Southeast Asian cultural backgrounds to follow, as food items used in traditional Mediterranean diets may not be readily available or frequently used in local cuisines.
It is therefore the aim of this study to first map out the nutritional composition of the traditional Mediterranean diet, derive substitute ingredients, and then develop an Asian version of the Mediterranean diet that can be accepted and easily adopted by the Asian population while retaining the beneficial nutritional characteristics.
Following this, NAFLD patients will be recruited for the sensory evaluation of the Asian Mediterranean diet. Specifically for this study, the researchers are keen to focus on a clinical condition (i.e. NAFLD) that has been demonstrated to reap positive effects from adopting a Mediterranean diet. As such, this is a pre-intervention study with a focus on development and evaluating its acceptability among NAFLD patients.
- Conditions
- Fatty Liver, Nonalcoholic
- Keywords
- Mediterranean Diet
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory Evaluation Test Score NAFLD
Score of sensory evaluation test to assess the acceptability of Asian Mediterranean diet in subjects with NAFLD on a 7-point Likert scale. Lower score on the 7-point Likert scale of 1 to 7 (1 = Like Very Much, 7 = Dislike Very Much) would mean a better outcome.
Measured: 15 April to 27 Dec 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start15 Apr 2024
- Primary completion16 Oct 2024
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Fatty Liver, NonalcoholicStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore Health Services
- Responsible party
- Principal investigator, Verena Tan Ming Hui, Singapore Institute of Technology
- Investigators
- Verena Tan, Ph.D, Principal investigator, +65 9172 4062
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06321211
- Sponsor's protocol ID
- RECAS-0244
- Acronym
- aMed
- Status last verified
- May 2026
- First submitted
- 29 Feb 2024
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Anania C, Perla FM, Olivero F, Pacifico L, Chiesa C. Mediterranean diet and nonalcoholic fatty liver disease. World J Gastroenterol. 2018 May 21;24(19):2083-2094. doi: 10.3748/wjg.v24.i19.2083.
PubMed 29785077Romero-Gomez M, Zelber-Sagi S, Trenell M. Treatment of NAFLD with diet, physical activity and exercise. J Hepatol. 2017 Oct;67(4):829-846. doi: 10.1016/j.jhep.2017.05.016. Epub 2017 May 23.
PubMed 28545937Abenavoli L, Greco M, Milic N, Accattato F, Foti D, Gulletta E, Luzza F. Effect of Mediterranean Diet and Antioxidant Formulation in Non-Alcoholic Fatty Liver Disease: A Randomized Study. Nutrients. 2017 Aug 12;9(8):870. doi: 10.3390/nu9080870.
PubMed 28805669Tan VMH, Chiah GTL, Lee Y, Lim IY, Cheah MCC, Goh GBB. Development of the Asian Mediterranean Diet and its sensory acceptability in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). BMC Nutr. 2026 Apr 13;12(1):97. doi: 10.1186/s40795-026-01318-z.
PubMed 41975554
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Novel Asian Mediterranean Diet and Its Acceptability in Non- Alcoholic Fatty Liver Disease (NAFLD)- a Pre-intervention Study
- ClinicalTrials.gov ID
- NCT06321211
- Acronym / sponsor ID
- aMed / RECAS-0244
- Conditions
- Fatty Liver, Nonalcoholic
- Keywords
- Mediterranean Diet
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Singapore Institute of TechnologyUniversity, hospital or other
- Collaborators
- Singapore Health Services
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 16 Oct 2024 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 20 Mar 2024 (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.
The goal of this pre-intervention study is test the acceptability of Asian version of the Mediterranean diet to NAFLD patients.
The main question[s] it aims to answer are:
- Whether Asian version of the Mediterranean diet that retains the nutritional composition and can be developed by mapping the components of the Mediterranean diet and finding substitute ingredients commonly eaten in Southeast Asia.
- Whether the 4-week menu cycle of newly developed novel Asian Mediterranean diet is acceptable among Singaporean local population.
Participants will participate in taste test sessions to find out if the Asian Mediterranean diet meals are acceptable to people with NAFLD.
Detailed description
Numerous studies have shown that Mediterranean diet decrease the risk of cardiovascular disease, metabolic syndrome, cancer and overall mortality characterized by being low in saturated fats and animal protein, high in antioxidants, fibre and monounsaturated fatty acids, and with an adequate omega-3 to omega-6 fatty acid balance.
Recent studies have proved that adherence to a Mediterranean diet is beneficial for non-alcoholic fatty liver disease (NAFLD) as it provides antioxidants and anti-inflammatory nutrients that slows the development of hepatic steatosis.
However, adhering to the Mediterranean diet can be difficult for people of Southeast Asian cultural backgrounds to follow, as food items used in traditional Mediterranean diets may not be readily available or frequently used in local cuisines.
It is therefore the aim of this study to first map out the nutritional composition of the traditional Mediterranean diet, derive substitute ingredients, and then develop an Asian version of the Mediterranean diet that can be accepted and easily adopted by the Asian population while retaining the beneficial nutritional characteristics.
Following this, NAFLD patients will be recruited for the sensory evaluation of the Asian Mediterranean diet. Specifically for this study, the researchers are keen to focus on a clinical condition (i.e. NAFLD) that has been demonstrated to reap positive effects from adopting a Mediterranean diet. As such, this is a pre-intervention study with a focus on development and evaluating its acceptability among NAFLD patients.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- We plan to recruit adults diagnosed with NAFLD (outpatients) from the Department of Hepatology in Singapore General Hospital.
Key inclusion criteria (1 listed)
- Diagnosis of NAFLD, as determined clinically by imaging evidence of hepatic steatosis on ultrasound/CT/MRI
Key exclusion criteria (10 listed)
- Secondary causes of NAFLD (e.g. medication-induced)
- Unstable body weight (variation >5% within the preceding 3 months)
- Current use of weight loss medications
- Other liver diseases (viral hepatitis, auto-immune or cholestatic liver disease, Wilson's disease, hemochromatosis, alpha-1 anti-trypsin deficiency)
- Unstable diabetes (HbA1c >8.5%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensory Evaluation Test Score NAFLD
Time frame: 15 April to 27 Dec 2024
Score of sensory evaluation test to assess the acceptability of Asian Mediterranean diet in subjects with NAFLD on a 7-point Likert scale. Lower score on the 7-point Likert scale of 1 to 7 (1 = Like Very Much, 7 = Dislike Very Much) would mean a better outcome.
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 22 May 2026.
- Background: PubMed 29785077Anania C, Perla FM, Olivero F, Pacifico L, Chiesa C. Mediterranean diet and nonalcoholic fatty liver disease. World J Gastroenterol. 2018 May 21;24(19):2083-2094. doi: 10.3748/wjg.v24.i19.2083.
- Background: PubMed 28545937Romero-Gomez M, Zelber-Sagi S, Trenell M. Treatment of NAFLD with diet, physical activity and exercise. J Hepatol. 2017 Oct;67(4):829-846. doi: 10.1016/j.jhep.2017.05.016. Epub 2017 May 23.
- Background: PubMed 28805669Abenavoli L, Greco M, Milic N, Accattato F, Foti D, Gulletta E, Luzza F. Effect of Mediterranean Diet and Antioxidant Formulation in Non-Alcoholic Fatty Liver Disease: A Randomized Study. Nutrients. 2017 Aug 12;9(8):870. doi: 10.3390/nu9080870.
- Derived from this study: PubMed 41975554Tan VMH, Chiah GTL, Lee Y, Lim IY, Cheah MCC, Goh GBB. Development of the Asian Mediterranean Diet and its sensory acceptability in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). BMC Nutr. 2026 Apr 13;12(1):97. doi: 10.1186/s40795-026-01318-z.
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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.
Verena Tan, Ph.D principal investigator
+65 9172 4062
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fatty Liver, Nonalcoholic, run by Singapore Institute of Technology 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 1 inclusion and 10 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 22 May 2026. 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?
Sensory Evaluation Test Score NAFLD (time frame: 15 April to 27 Dec 2024). 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 NCT06321211, which also lists 4 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 22 May 2026.