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

Not Applicable

• Conditions: Obesity
• Interventions: Dietary Supplement: Synbiotic supplementation; Behavioral: Dietary intervention

• Registration Number: NCT05459909
• Lead Sponsor: Chinese University of Hong Kong

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

Study Timeline

• Study Start: 2020-07-01
• Status Verified: 2022-07
• Study First Submitted: 2022-07-07
• Study First Submitted QC: 2022-07-12
• Study First Posted: 2022-07-15
• Last Update Submitted: 2022-07-15
• Last Update Posted: 2022-07-19
• Primary Completion: 2023-12-31
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Synbiotic supplementation	Synbiotic supplementation	Synbiotic supplementation
Synbiotic supplementation & dietary intervention	Dietary intervention	Synbiotic supplementation \& dietary intervention
Dietary intervention	Dietary intervention	Dietary intervention
Synbiotic supplementation & dietary intervention	Synbiotic supplementation	Synbiotic supplementation \& dietary intervention

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Change in fasting glucose at week 8 compared with baseline	Week 0, 8	Fasting glucose 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

Trial Locations

Locations (1)

The Chinese University of Hong Kong; 🇭🇰 Shatin, Hong Kong