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

Sponsor

Chinese University of Hong Kong (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05459909

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Dietary Supplement: Synbiotic supplementation Behavioral: Dietary intervention	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jul 1, 2020

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Jul 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Synbiotic supplementation Synbiotic supplementation	Dietary Supplement: Synbiotic supplementation Daily supplementation of synbiotic
Experimental: Dietary intervention Dietary intervention	Behavioral: Dietary intervention Increased fruits and vegetables consumption
Experimental: Synbiotic supplementation & dietary intervention Synbiotic supplementation & dietary intervention	Dietary Supplement: Synbiotic supplementation Daily supplementation of synbiotic Behavioral: Dietary intervention Increased fruits and vegetables consumption

Arm

Intervention/Treatment

Experimental: Synbiotic supplementation

Synbiotic supplementation

Dietary Supplement: Synbiotic supplementation

Daily supplementation of synbiotic

Experimental: Dietary intervention

Dietary intervention

Behavioral: Dietary intervention

Increased fruits and vegetables consumption

Experimental: Synbiotic supplementation & dietary intervention

Synbiotic supplementation & dietary intervention

Dietary Supplement: Synbiotic supplementation

Daily supplementation of synbiotic

Behavioral: Dietary intervention

Increased fruits and vegetables consumption

Outcome Measures

Primary Outcome Measures

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)
Change in body fat percentage at week 8 compared with baseline [Week 0, 8]
Body fat percentage is assessed by bioimpedence

Secondary Outcome Measures

Change in fasting glucose at week 8 compared with baseline [Week 0, 8]
Fasting glucose in mmol/L
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/L
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 95 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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