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

Primary Purpose

Obesity

Status
Active
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Synbiotic supplementation
Dietary intervention
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Overweight, Synbiotic, Diet, Metabolic dysfunction

Eligibility Criteria

20 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The Chinese University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Synbiotic supplementation

Dietary intervention

Synbiotic supplementation & dietary intervention

Arm Description

Synbiotic supplementation

Dietary intervention

Synbiotic supplementation & dietary intervention

Outcomes

Primary Outcome Measures

Change in body weight at week 8 compared with baseline
Body weight in kilogram
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)
Change in body fat percentage at week 8 compared with baseline
Body fat percentage is assessed by bioimpedence

Secondary Outcome Measures

Change in fasting glucose at week 8 compared with baseline
Fasting glucose in mmol/L
Change in fasting insulin at week 8 compared with baseline
Fasting insulin in pmol/L
Changes in fasting lipids at week 8 compared with baseline
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
The composition of the gut microbiota (bacteriome) of stool samples is assessed by 16S rRNA gene sequencing

Full Information

First Posted
July 7, 2022
Last Updated
July 15, 2022
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05459909
Brief Title
The Effect of Synbiotic and Diet Modification Among Overweight or Obese Hong Kong Chinese
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Overweight, Synbiotic, Diet, Metabolic dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Synbiotic supplementation
Arm Type
Experimental
Arm Description
Synbiotic supplementation
Arm Title
Dietary intervention
Arm Type
Experimental
Arm Description
Dietary intervention
Arm Title
Synbiotic supplementation & dietary intervention
Arm Type
Experimental
Arm Description
Synbiotic supplementation & dietary intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Synbiotic supplementation
Intervention Description
Daily supplementation of synbiotic
Intervention Type
Behavioral
Intervention Name(s)
Dietary intervention
Intervention Description
Increased fruits and vegetables consumption
Primary Outcome Measure Information:
Title
Change in body weight at week 8 compared with baseline
Description
Body weight in kilogram
Time Frame
Week 0, 8
Title
Change in Body Mass Index (BMI) at week 8 compared with baseline
Description
BMI = Body weight (in kilograms) divided by square of body height (in meters)
Time Frame
Week 0, 8
Title
Change in body fat percentage at week 8 compared with baseline
Description
Body fat percentage is assessed by bioimpedence
Time Frame
Week 0, 8
Secondary Outcome Measure Information:
Title
Change in fasting glucose at week 8 compared with baseline
Description
Fasting glucose in mmol/L
Time Frame
Week 0, 8
Title
Change in fasting insulin at week 8 compared with baseline
Description
Fasting insulin in pmol/L
Time Frame
Week 0, 8
Title
Changes in fasting lipids at week 8 compared with baseline
Description
Triglycerides in mmol/L Total cholesterol in mmol/L HDL-cholesterol in mmol/L
Time Frame
Week 0, 8
Title
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
Description
The composition of the gut microbiota (bacteriome) of stool samples is assessed by 16S rRNA gene sequencing
Time Frame
Week 0, 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hoi Shan Kwan, PhD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Peter Chi Keung Cheung, PhD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Susana Lauw, MSc
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nelson Kei, BSc
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Shatin
ZIP/Postal Code
000000
Country
Hong Kong

12. IPD Sharing Statement

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

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