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

NCT06321211 | Active Not Recruiting

• 1 other identifier: RECAS-0244
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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. 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. 2.Whether the 4-week menu cycle of newly developed novel Asian Mediterranean diet is acceptable among Singaporean local population.

Conditions

Fatty Liver, Nonalcoholic

Keywords

Mediterranean Diet

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Singapore Institute of Technology: lead
• Singapore Health Services: collaborator

Study Sites (1)

Singapore Institute of Technology

Singapore, 138683, Singapore

Location

Related Publications (3)

• 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.

  PMID: 29785077 BACKGROUND

• 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.

  PMID: 28545937 BACKGROUND

• 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.

  PMID: 28805669 BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Verena Tan, Ph.D

  +65 9172 4062

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 20, 2024
• Study Start: April 15, 2024
• Primary Completion: October 16, 2024
• Study Completion: December 27, 2024
• Last Updated: October 28, 2024

Record last verified: 2024-10

Locations

SG (1)