The Effect of Synbiotic and Diet Modification Among Overweight or Obese Hong Kong Chinese

Study Overview
=================
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

Official Title
-----------------
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

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: Synbiotic supplementation
* Behavioral: Dietary intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Waist circumference ≥90cm in men and ≥80cm in women BMI >23.0kg/m2 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 95 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Synbiotic supplementation<br>Synbiotic supplementation | Dietary Supplement: Synbiotic supplementation<br>* Daily supplementation of synbiotic<br>|
| Experimental: Dietary intervention<br>Dietary intervention | Behavioral: Dietary intervention<br>* Increased fruits and vegetables consumption<br>|
| Experimental: Synbiotic supplementation & dietary intervention<br>Synbiotic supplementation & dietary intervention | Dietary Supplement: Synbiotic supplementation<br>* Daily supplementation of synbiotic<br>Behavioral: Dietary intervention<br>* Increased fruits and vegetables consumption<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight at week 8 compared with baseline | Body weight in kilogram | Week 0, 8 | 
| Change in Body Mass Index (BMI) at week 8 compared with baseline | BMI = Body weight (in kilograms) divided by square of body height (in meters) | Week 0, 8 | 
| Change in body fat percentage at week 8 compared with baseline | Body fat percentage is assessed by bioimpedence | Week 0, 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fasting glucose at week 8 compared with baseline | Fasting glucose in mmol/L | Week 0, 8 | 
| Change in fasting insulin at week 8 compared with baseline | Fasting insulin in pmol/L | Week 0, 8 | 
| Changes in fasting lipids at week 8 compared with baseline | Triglycerides in mmol/L Total cholesterol in mmol/L HDL-cholesterol in mmol/L | 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 | The composition of the gut microbiota (bacteriome) of stool samples is assessed by 16S rRNA gene sequencing | Week 0, 8 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Overweight, Synbiotic, Diet, Metabolic dysfunction