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

Diet, Food and Nutrition Clinical Trial

— DURIOME  

Official title:

Precision Nutrition - Impacts of Durian Consumption on Human Microbiome and Metabolome in Healthy Staff Volunteers From SingHealth

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06194084
• Other study ID #: DURIOME
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: July 30, 2024

Study information

• Verified date: December 2023
• Source: National Cancer Centre, Singapore
• Contact: Jason YS CHAN, MD, PhD
• Phone: +65 64368000
• Email: jason.chan.y.s[@]singhealth.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Diet, Food and Nutrition

Intervention

Other:
• Two-sequence of durian pulp doses (100 g and 200 g)
Participants first 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.

Locations

Country	Name	City	State
Singapore	National Cancer Centre, Singapore	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Centre, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Plasma Samples obtained from 50 healthy participants form different multi-ethnicity (Malays, Chinese and Indians) will be genotyped using a custom single nucleotide polymorphism (SNP) genotyping array (Illumina OncoArray-500K Bead Chip).	The association between the SNP in distinct ethnic groups and gut microbiome patterns will be investigated.	Baseline.
Primary	Fasted Blood Glucose	Changes in Fasted Blood Glucose (mg/dL), before & after Durian intervention.	Baseline, 1 week after Intervention (100gm of durian consumption), 2 weeks after Intervention (200gm of durian consumption), Post-Intervention Wash-out (2 weeks after intervention).
Primary	HbA1C	Changes in HbA1C (%) before & after Durian intervention.	Baseline, 1 week after Intervention (100gm of durian consumption), 2 weeks after Intervention (200gm of durian consumption), Post-Intervention Wash-out (2 weeks after intervention).
Primary	Total Cholesterol	Changes in Total Cholesterol (mg/dL) before & after Durian Intervention.	Baseline, 1 week after Intervention (100gm of durian consumption), 2 weeks after Intervention (200gm of durian consumption), Post-Intervention Wash-out (2 weeks after intervention).
Primary	HDL Cholesterol	Changes in HDL Cholesterol (mg/dL) before & after Durian intervention.	Baseline, 1 week after Intervention (100gm of durian consumption), 2 weeks after Intervention (200gm of durian consumption), Post-Intervention Wash-out (2 weeks after intervention).
Primary	LDL Cholesterol	Changes in LDL Cholesterol (mg/dL) before & after Durian intervention.	Baseline, 1 week after Intervention (100gm of durian consumption), 2 weeks after Intervention (200gm of durian consumption), Post-Intervention Wash-out (2 weeks after intervention).
Primary	Cholesterol/HDL Ratio	Changes in Cholesterol/HDL ratio before & after Durian intervention.	Baseline, 1 week after Intervention (100gm of durian consumption), 2 weeks after Intervention (200gm of durian consumption), Post-Intervention Wash-out (2 weeks after intervention).
Primary	Triglycerides	Changes in Triglycerides (mg/dL) before & after Durian intervention.	Baseline, 1 week after Intervention (100gm of durian consumption), 2 weeks after Intervention (200gm of durian consumption), Post-Intervention Wash-out (2 weeks after intervention).
Primary	Carbohydrates	Food record for carbohydrate intake.	Baseline, 1 week after Intervention (100gm of durian consumption), 2 weeks after Intervention (200gm of durian consumption), Post-Intervention Wash-out (2 weeks after intervention).
Primary	Protein	Food record for protein intake.	Baseline, 1 week after Intervention (100gm of durian consumption), 2 weeks after Intervention (200gm of durian consumption), Post-Intervention Wash-out (2 weeks after intervention).
Primary	Fats	Food record for fat intake.	Baseline, 1 week after Intervention (100gm of durian consumption), 2 weeks after Intervention (200gm of durian consumption), Post-Intervention Wash-out (2 weeks after intervention).
Primary	Dietary Fibre	Food record for dietary fibre intake.	Baseline, 1 week after Intervention (100gm of durian consumption), 2 weeks after Intervention (200gm of durian consumption), Post-Intervention Wash-out (2 weeks after intervention).
Primary	Cholesterol	Food record for cholesterol intake.	Baseline, 1 week after Intervention (100gm of durian consumption), 2 weeks after Intervention (200gm of durian consumption), Post-Intervention Wash-out (2 weeks after intervention).
Primary	Sodium	Food record for sodium intake.	Baseline, 1 week after Intervention (100gm of durian consumption), 2 weeks after Intervention (200gm of durian consumption), Post-Intervention Wash-out (2 weeks after intervention).
Primary	Sugar	Food record for sugar intake.	Baseline, 1 week after Intervention (100gm of durian consumption), 2 weeks after Intervention (200gm of durian consumption), Post-Intervention Wash-out (2 weeks after intervention).
Secondary	Changes in gut microbiome composition before and after Intervention.	The effect of intervention on alpha and beta diversity of the fecal microbial community will be evaluated by 16s sequencing (using illumina MiSeq platforms) of feal bacterial DNA at baseline and after each intervention period.	Baseline, 1 week after Intervention (100gm of durian consumption), 2 weeks after Intervention (200gm of durian consumption), Post-Intervention Wash-out (2 weeks after intervention).
Secondary	Changes in metabolomes before and after Intervention.	Changes in the plasma metabolomics will be evaluated via LC-QTOF-MS to identify the metabolomic markers at baseline and after each intervention period. Whereas changes in fecal microbial metabolomic will be determined via GC-QTOF-MS at baseline and after each intervention period.	Baseline, 1 week after Intervention (100gm of durian consumption), 2 weeks after Intervention (200gm of durian consumption), Post-Intervention Wash-out (2 weeks after intervention).