Impacts of Durian Consumption on Human Microbiome and Metabolome in Healthy Staff Volunteers (DURIOME)

National Cancer Centre, Singapore

Status: Enrolling

Conditions: Diet, Food and Nutrition

Treatments: Other: Two-sequence of durian pulp doses (100 g and 200 g)

Study type: Interventional

Funder types: Other

Identifiers

NCT06194084

DURIOME

Details and patient eligibility

About

This clinical study investigates the impacts of daily durian consumption on gut microbiota, gut microbial metabolites, and host metabolome in healthy individuals.

Full description

Participants will go through an initial washout maintaining a low-fiber diet for 14 days. After washout, participants will be instructed to consume 100 grams of durian pulp every day following their breakfast or dinner for 1 week. Participants will then continue to consume 200 grams of durian pulp every day during the 2nd week of intervention and then will go through another washout for 2 weeks. During the intervention period, participants will be informed to maintain low-fiber diet. All participants will be required to note down their stool consistency and stool frequency and 3-days dietary records. Stool and blood samples will be collected at 4 time points during the study period (baseline, 1-week of intervention, 2-weeks of intervention and 2-weeks washout) and will be stored at -80 °C until analysis.

The first outcomes of this study will provide insights into the interplay between durian consumption, gut microbiome, and host metabolome, as well as whether durian consumption can improve the clinical parameters (plasma glucose levels, lipid profiles and HbA1c levels) of healthy subjects. The interplay between diets, gut microbiome, host metabolome and genetic polymorphism data in healthy population will lay the groundwork to develop the precision nutrition strategy based on our regional food. These findings have potential to improve the health and well-being of the communities in our region.

Enrollment: 50 estimated patients

Sex: All

Ages: 21 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Male and/or female subjects between the ages of 21 and 60 years, inclusive
2. Willing and able to provide written informed consent
3. Must be in generally good health with clinically insignificant screening results (Fasting plasma glucose level & Lipid profile), as determined by the Investigator
4. Agrees to consume durian for 2 weeks
5. Agrees to maintain a low-fiber diet during the intervention
6. Have not received any antibiotics therapy, consumed prebiotics, probiotics, symbiotic /vitamin supplement, and/or TCM for at least 1 month before the start of the study
7. Have not received any medical treatment that would impact on intestinal microbiota at least 6 months before the start of the study or during the study
8. Recent COVID-19 vaccination received or infection with COVID-19 at least 2 months ago

Exclusion criteria

1. Known or suspected sensitivity/allergy to durian
2. Multiple food/drug allergies
3. Smoker
4. History or presence of current metabolic conditions and gastrointestinal diseases
5. Diagnosed with Inflammatory Bowel Disease (IBD) or significant liver enzyme abnormality
6. Presence of current haemorrhoids or piles causing rectal bleeding when passing stool
7. Pregnant, breastfeeding or intending to conceive during study period

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Intervention - durian pulp.

Experimental group

Description:

Two-sequence of doses (100 g and 200 g) of durian pulp.

Treatment:

Other: Two-sequence of durian pulp doses (100 g and 200 g)