Clinical trial NCT06194084: Impacts of Durian Consumption on Human Microbiome and Metabolome in Healthy Staff Volunteers
Official title: Precision Nutrition - Impacts of Durian Consumption on Human Microbiome and Metabolome in Healthy Staff Volunteers From SingHealth
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diet, Food and Nutrition
Keywords: Precision Nutrition
Durian
Gut Microbiome
Metabolome
Lead sponsor: National Cancer Centre, Singapore
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Fasted Blood Glucose
timeFrame: 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).
measure: HbA1C
timeFrame: 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).
measure: Total Cholesterol
timeFrame: 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).
measure: HDL Cholesterol
timeFrame: 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).
measure: LDL Cholesterol
timeFrame: 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).
measure: Cholesterol/HDL Ratio
timeFrame: 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).
measure: Triglycerides
timeFrame: 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).
measure: Carbohydrates
timeFrame: 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).
measure: Protein
timeFrame: 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).
measure: Fats
timeFrame: 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).
measure: Dietary Fibre
timeFrame: 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).
measure: Cholesterol
timeFrame: 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).
measure: Sodium
timeFrame: 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).
measure: Sugar
timeFrame: 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 outcomes:
measure: Changes in gut microbiome composition before and after Intervention.
timeFrame: 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).
measure: Changes in metabolomes before and after Intervention.
timeFrame: 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).
Other outcomes:
measure: 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).
timeFrame: Baseline.
Locations:
city: Singapore
country: Singapore
facility: National Cancer Centre, Singapore
Study officials:
affiliation: National Cancer Centre, Singapore
name: Jason YS CHAN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: