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

Fatty Liver, Nonalcoholic Clinical Trial

— aMed  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06321211
• Other study ID #: RECAS-0244
• Status: Recruiting
• Start date: April 15, 2024
• Est. completion date: December 27, 2024

Study information

• Verified date: May 2024
• Source: Singapore Institute of Technology
• Contact: Ye Won Lee
• Phone: +6584347782
• Email: yewon.lee[@]singaporetech.edu.sg
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 27, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Fatty Liver, Nonalcoholic
• Non-alcoholic Fatty Liver Disease

Locations

Country	Name	City	State
Singapore	Singapore Institute of Technology	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Singapore Institute of Technology	Singapore Health Services

Country where clinical trial is conducted

Singapore, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	15 April to 27 Dec 2024