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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05459909
• Other study ID #: SYN-DIET-OB-RCT
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: July 31, 2024

Study information

• Verified date: July 2022
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: July 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Dietary Supplement:
• Synbiotic supplementation
Daily supplementation of synbiotic

Behavioral:
• Dietary intervention
Increased fruits and vegetables consumption

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight at week 8 compared with baseline	Body weight in kilogram	Week 0, 8
Primary	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
Primary	Change in body fat percentage at week 8 compared with baseline	Body fat percentage is assessed by bioimpedence	Week 0, 8
Secondary	Change in fasting glucose at week 8 compared with baseline	Fasting glucose in mmol/L	Week 0, 8
Secondary	Change in fasting insulin at week 8 compared with baseline	Fasting insulin in pmol/L	Week 0, 8
Secondary	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
Secondary	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