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Completed

NCT Number: NCT06321211

Development of a Novel Asian Mediterranean Diet and Its Acceptability in NAFLD

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.

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Key information

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Singapore Institute of Technology

Singapore, 138683

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Singapore Institute of Technology

Other

Collaborators

  • Singapore Health Services

Registry information

Official study title

Development of a Novel Asian Mediterranean Diet and Its Acceptability in Non- Alcoholic Fatty Liver Disease (NAFLD)- a Pre-intervention Study

Acronym: aMed

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Mar 20, 2024
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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