An interventional study of Two-sequence of durian pulp doses (100 g and 200 g) in Diet, Food and Nutrition, sponsored by National Cancer Centre, Singapore. Completed at 1 site in Singapore. Open to participants aged 21 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-01.
Sponsored by National Cancer Centre, Singapore · Not applicable, Interventional, and Prevention
This clinical study investigates the impacts of daily durian consumption on gut microbiota, gut microbial metabolites, and host metabolome in healthy individuals.
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.
National Cancer Centre, Singapore is the lead sponsor of 116 studies on the registry; 30 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Two-sequence of doses (100 g and 200 g) of durian pulp.
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.
Fasted Blood Glucose
Changes in Fasted Blood Glucose (mg/dL), before \& after Durian 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).
HbA1C
Changes in HbA1C (%) before \& after Durian 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).
Total Cholesterol
Changes in Total Cholesterol (mg/dL) before \& after Durian 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).
HDL Cholesterol
Changes in HDL Cholesterol (mg/dL) before \& after Durian 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).
LDL Cholesterol
Changes in LDL Cholesterol (mg/dL) before \& after Durian 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).
Cholesterol/HDL Ratio
Changes in Cholesterol/HDL ratio before \& after Durian 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).
Triglycerides
Changes in Triglycerides (mg/dL) before \& after Durian 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).
Carbohydrates
Food record for carbohydrate intake.
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).
Protein
Food record for protein intake.
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).
Fats
Food record for fat intake.
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).
Dietary Fibre
Food record for dietary fibre intake.
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).
Cholesterol
Food record for cholesterol intake.
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).
Sodium
Food record for sodium intake.
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).
Sugar
Food record for sugar intake.
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 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.
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 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.
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).
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.
Time frame: Baseline.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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National Cancer Centre, Singapore