A Study of the Effect of Synbiotic Supplementation and/or Dietary Intervention With Fruits and Vegetables on the Risk of Metabolic Dysfunction and Overweight or Obesity Among Hong Kong Chinese
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in body fat percentage at week 8 compared with baseline
研究概览
简要总结
Synbiotic is a nutritional supplement that contains both prebiotic and probiotic. Probiotics are beneficial microorganisms, while prebiotics are foods that help the growth of beneficial microorganisms in the gut. In the study, dietary intervention with fruits and vegetables and/or synbiotic supplementation with be administered to Hong Kong Chinese subjects for eight weeks. Changes in the composition and diversity of intestinal microbiota, and markers indicative of obesity, chronic inflammation and metabolic dysfunction will be assessed throughout the whole period. This study will further provide a scientific basis for the intake of synbiotics for reducing the risk of overweight and obesity among Hong Kong Chinese. Furthermore, the results will bridge to further research into the most desirable gut microbiome profile, hence facilitating personalised nutrition for optimal health.
详细描述
This is an 8-week randomized controlled dietary interventional trial.The objectives of this study include:
- To investigate the effects of synbiotic supplementation and/or dietary intervention with fruits and vegetables on gut microbial diversity and composition, and on inflammation, metabolic functioning, overweight and obesity among Hong Kong Chinese
- To study whether the changes in gut microbial diversity and composition upon the interventions in Hong Kong Chinese are correlated with metabolic functioning and inflammation, as well as overweight or obesity
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Waist circumference ≥90cm in men and ≥80cm in women
- •BMI >23.0kg/m2
排除标准
- •Practicing dietary restrictions
- •Using cholesterol-lowering, antihypertensive, anti-inflammatory drugs or Chinese medicines
- •Consuming laxatives, any gastrointestinal medication, probiotics, prebiotics, synbiotics or antibiotics
- •Alcohol abuser
- •Currently pregnant or lactating
研究组 & 干预措施
Synbiotic supplementation & dietary intervention
Synbiotic supplementation & dietary intervention
干预措施: Synbiotic supplementation (Dietary Supplement)
Synbiotic supplementation & dietary intervention
Synbiotic supplementation & dietary intervention
干预措施: Dietary intervention (Behavioral)
Dietary intervention
Dietary intervention
干预措施: Dietary intervention (Behavioral)
Synbiotic supplementation
Synbiotic supplementation
干预措施: Synbiotic supplementation (Dietary Supplement)
结局指标
主要结局
Change in body fat percentage at week 8 compared with baseline
时间窗: Week 0, 8
Body fat percentage is assessed by bioimpedence
Change in body weight at week 8 compared with baseline
时间窗: Week 0, 8
Body weight in kilogram
Change in Body Mass Index (BMI) at week 8 compared with baseline
时间窗: Week 0, 8
BMI = Body weight (in kilograms) divided by square of body height (in meters)
次要结局
- Change in fasting insulin at week 8 compared with baseline(Week 0, 8)
- Changes in fasting lipids at week 8 compared with baseline(Week 0, 8)
- Change in fasting glucose at week 8 compared with baseline(Week 0, 8)
- Use of 16S rRNA gene sequencing to assess the changes in the composition of the gut microbiota (bacteriome) of stool samples at week 8 compared with baseline(Week 0, 8)
研究者
Lauw Susana
Principal Investigator
Chinese University of Hong Kong