Precision Nutrition - Impacts of Durian Consumption on Human Microbiome and Metabolome in Healthy Staff Volunteers From SingHealth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- HbA1C
研究概览
简要总结
This clinical study investigates the impacts of daily durian consumption on gut microbiota, gut microbial metabolites, and host metabolome in healthy individuals.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Known or suspected sensitivity/allergy to durian
- •Multiple food/drug allergies
- •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
结局指标
主要结局
HbA1C
时间窗: 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.
Triglycerides
时间窗: 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.
Sugar
时间窗: 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.
LDL Cholesterol
时间窗: 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.
Cholesterol/HDL Ratio
时间窗: 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.
Sodium
时间窗: 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.
Fasted Blood Glucose
时间窗: 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.
Total Cholesterol
时间窗: 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.
HDL Cholesterol
时间窗: 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.
Protein
时间窗: 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.
Cholesterol
时间窗: 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.
Carbohydrates
时间窗: 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.
Fats
时间窗: 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.
Dietary Fibre
时间窗: 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.
次要结局
- Changes in gut microbiome composition before and after 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).)
- Changes in metabolomes before and after 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).)