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Completed

NCT Number: NCT06194084

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

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

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Key information

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cancer Centre, Singapore

Singapore, 168583

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and/or female subjects between the ages of 21 and 60 years, inclusive
  • Willing and able to provide written informed consent
  • Must be in generally good health with clinically insignificant screening results (Fasting plasma glucose level & Lipid profile), as determined by the Investigator
  • Agrees to consume durian for 2 weeks
  • Agrees to maintain a low-fiber diet during the intervention
  • 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
  • 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
  • Recent COVID-19 vaccination received or infection with COVID-19 at least 2 months ago

Exclusion criteria

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

Treatment and study plan

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

Other

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.

Primary outcomes

  1. Fasted Blood Glucose

    Time frame: 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).

    Changes in Fasted Blood Glucose (mg/dL), before & after Durian intervention.

  2. HbA1C

    Time frame: 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).

    Changes in HbA1C (%) before & after Durian intervention.

  3. Total Cholesterol

    Time frame: 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).

    Changes in Total Cholesterol (mg/dL) before & after Durian Intervention.

  4. HDL Cholesterol

    Time frame: 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).

    Changes in HDL Cholesterol (mg/dL) before & after Durian intervention.

  5. LDL Cholesterol

    Time frame: 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).

    Changes in LDL Cholesterol (mg/dL) before & after Durian intervention.

  6. Cholesterol/HDL Ratio

    Time frame: 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).

    Changes in Cholesterol/HDL ratio before & after Durian intervention.

  7. Triglycerides

    Time frame: 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).

    Changes in Triglycerides (mg/dL) before & after Durian intervention.

  8. Carbohydrates

    Time frame: 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).

    Food record for carbohydrate intake.

  9. Protein

    Time frame: 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).

    Food record for protein intake.

  10. Fats

    Time frame: 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).

    Food record for fat intake.

  11. Dietary Fibre

    Time frame: 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).

    Food record for dietary fibre intake.

  12. Cholesterol

    Time frame: 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).

    Food record for cholesterol intake.

  13. Sodium

    Time frame: 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).

    Food record for sodium intake.

  14. Sugar

    Time frame: 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).

    Food record for sugar intake.

Secondary outcomes

  1. Changes in gut microbiome composition before and after Intervention.

    Time frame: 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).

    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.

  2. Changes in metabolomes before and after Intervention.

    Time frame: 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).

    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.

Other outcomes

  1. 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).

    Time frame: Baseline.

    The association between the SNP in distinct ethnic groups and gut microbiome patterns will be investigated.

Sponsors and collaborators

Lead sponsor

National Cancer Centre, Singapore

Other

Registry information

Official study title

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

Acronym: DURIOME

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 8, 2024
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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