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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: Synbiotic supplementation; Behavioral: Dietary intervention

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Shatin, Hong Kong, 000000
    • The Chinese University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Study Chair: Hoi Shan Kwan, PhD, Chinese University of Hong Kong; Study Director: Peter Chi Keung Cheung, PhD, Chinese University of Hong Kong; Principal Investigator: Susana Lauw, MSc, Chinese University of Hong Kong; Principal Investigator: Nelson Kei, BSc, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): July 31, 2024

Study Registration Dates

• First Submitted: July 7, 2022
• First Submitted That Met QC Criteria: July 12, 2022
• First Posted (Actual): July 15, 2022

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 15, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Obesity; Overweight; Diet; Synbiotic; Metabolic dysfunction
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Overweight
• Other Study ID Numbers: SYN-DIET-OB-RCT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No