The Effect of Synbiotic and Diet Modification Among Overweight or Obese Hong Kong Chinese
- Conditions
- Obesity
- Registration Number
- NCT05459909
- Lead Sponsor
- Chinese University of Hong Kong
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- Waist circumference ≥90cm in men and ≥80cm in women
- BMI >23.0kg/m2
- Practicing dietary restrictions
- Using cholesterol-lowering, antihypertensive, anti-inflammatory drugs or Chinese medicines
- Consuming laxatives, any gastrointestinal medication, probiotics, prebiotics, synbiotics or antibiotics
- Smokers
- Alcohol abuser
- Currently pregnant or lactating
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in body fat percentage at week 8 compared with baseline Week 0, 8 Body fat percentage is assessed by bioimpedence
Change in body weight at week 8 compared with baseline Week 0, 8 Body weight in kilogram
Change in Body Mass Index (BMI) at week 8 compared with baseline Week 0, 8 BMI = Body weight (in kilograms) divided by square of body height (in meters)
- Secondary Outcome Measures
Name Time Method 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 The composition of the gut microbiota (bacteriome) of stool samples is assessed by 16S rRNA gene sequencing
Change in fasting insulin at week 8 compared with baseline Week 0, 8 Fasting insulin in pmol/L
Changes in fasting lipids at week 8 compared with baseline Week 0, 8 * Triglycerides in mmol/L
* Total cholesterol in mmol/L
* HDL-cholesterol in mmol/LChange in fasting glucose at week 8 compared with baseline Week 0, 8 Fasting glucose in mmol/L
Trial Locations
- Locations (1)
The Chinese University of Hong Kong
🇭🇰Shatin, Hong Kong
The Chinese University of Hong Kong🇭🇰Shatin, Hong Kong