Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05459909

The Effect of Synbiotic and Diet Modification Among Overweight or Obese 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Chinese University of Hong Kong

Shatin, 000000, Hong Kong

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Synbiotic supplementation

Dietary Supplement

Daily supplementation of synbiotic

Dietary intervention

Behavioral

Increased fruits and vegetables consumption

Primary outcomes

  1. Change in body weight at week 8 compared with baseline

    Time frame: Week 0, 8

    Body weight in kilogram

  2. Change in Body Mass Index (BMI) at week 8 compared with baseline

    Time frame: Week 0, 8

    BMI = Body weight (in kilograms) divided by square of body height (in meters)

  3. Change in body fat percentage at week 8 compared with baseline

    Time frame: Week 0, 8

    Body fat percentage is assessed by bioimpedence

Secondary outcomes

  1. Change in fasting glucose at week 8 compared with baseline

    Time frame: Week 0, 8

    Fasting glucose in mmol/L

  2. Change in fasting insulin at week 8 compared with baseline

    Time frame: Week 0, 8

    Fasting insulin in pmol/L

  3. Changes in fasting lipids at week 8 compared with baseline

    Time frame: Week 0, 8

    • Triglycerides in mmol/L
    • Total cholesterol in mmol/L
    • HDL-cholesterol in mmol/L

  4. 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

    Time frame: Week 0, 8

    The composition of the gut microbiota (bacteriome) of stool samples is assessed by 16S rRNA gene sequencing

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2028
Study completion
2030
First posted
Jul 15, 2022
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.