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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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05459909
Enrollment
100
Registered
2022-07-15
Start date
2020-07-01
Completion date
2030-07-31
Last updated
2026-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Obesity, Overweight, Synbiotic, Diet, Metabolic dysfunction

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

Interventions

DIETARY_SUPPLEMENTSynbiotic supplementation

Daily supplementation of synbiotic

BEHAVIORALDietary intervention

Increased fruits and vegetables consumption

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 95 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in body weight at week 8 compared with baselineWeek 0, 8Body weight in kilogram
Change in Body Mass Index (BMI) at week 8 compared with baselineWeek 0, 8BMI = Body weight (in kilograms) divided by square of body height (in meters)
Change in body fat percentage at week 8 compared with baselineWeek 0, 8Body fat percentage is assessed by bioimpedence

Secondary

MeasureTime frameDescription
Change in fasting glucose at week 8 compared with baselineWeek 0, 8Fasting glucose in mmol/L
Change in fasting insulin at week 8 compared with baselineWeek 0, 8Fasting insulin in pmol/L
Changes in fasting lipids at week 8 compared with baselineWeek 0, 8* 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 baselineWeek 0, 8The composition of the gut microbiota (bacteriome) of stool samples is assessed by 16S rRNA gene sequencing

Countries

Hong Kong

Contacts

STUDY_CHAIRHoi Shan Kwan, PhD

Chinese University of Hong Kong

STUDY_DIRECTORPeter Chi Keung Cheung, PhD

Chinese University of Hong Kong

PRINCIPAL_INVESTIGATORSusana Lauw, MSc

Chinese University of Hong Kong

PRINCIPAL_INVESTIGATORNelson Kei, BSc

Chinese University of Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 10, 2026