Clinical trial NCT06321211: Development of a Novel Asian Mediterranean Diet and Its Acceptability in NAFLD
Official title: Development of a Novel Asian Mediterranean Diet and Its Acceptability in Non- Alcoholic Fatty Liver Disease (NAFLD)- a Pre-intervention Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Fatty Liver, Nonalcoholic
Keywords: Mediterranean Diet
Lead sponsor: Singapore Institute of Technology
Sponsor class: OTHER
Collaborators: name: Singapore Health Services
First posted: 2024-03-20
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We plan to recruit adults diagnosed with NAFLD (outpatients) from the Department of Hepatology in Singapore General Hospital.

Brief 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 Mediterranean diet and finding substitute ingredients commonly eaten in Southeast Asia.
2. 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of NAFLD, as determined clinically by imaging evidence of hepatic steatosis on ultrasound/CT/MRI

Exclusion Criteria:

* 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
* Inability to provide informed consent
* Pregnancy and lactation
* Problems with tasting and smelling
* Food allergy/intolerances/restrictions

Primary outcomes:
measure: Sensory Evaluation Test Score NAFLD
timeFrame: 15 April to 27 Dec 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore Institute of Technology
Study officials:
affiliation: +65 9172 4062
name: Verena Tan, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Romero-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.
citation: Abenavoli 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.