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

NCT ID: NCT05459909

Last Updated: 2022-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2024-07-31

Brief Summary

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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

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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

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Synbiotic supplementation

Synbiotic supplementation

Group Type EXPERIMENTAL

Synbiotic supplementation

Intervention Type DIETARY_SUPPLEMENT

Daily supplementation of synbiotic

Dietary intervention

Dietary intervention

Group Type EXPERIMENTAL

Dietary intervention

Intervention Type BEHAVIORAL

Increased fruits and vegetables consumption

Synbiotic supplementation & dietary intervention

Synbiotic supplementation \& dietary intervention

Group Type EXPERIMENTAL

Synbiotic supplementation

Intervention Type DIETARY_SUPPLEMENT

Daily supplementation of synbiotic

Dietary intervention

Intervention Type BEHAVIORAL

Increased fruits and vegetables consumption

Interventions

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Synbiotic supplementation

Daily supplementation of synbiotic

Intervention Type DIETARY_SUPPLEMENT

Dietary intervention

Increased fruits and vegetables consumption

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Lauw Susana

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hoi Shan Kwan, PhD

Role: STUDY_CHAIR

Chinese University of Hong Kong

Peter Chi Keung Cheung, PhD

Role: STUDY_DIRECTOR

Chinese University of Hong Kong

Susana Lauw, MSc

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Nelson Kei, BSc

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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The Chinese University of Hong Kong

Shatin, , Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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SYN-DIET-OB-RCT

Identifier Type: -

Identifier Source: org_study_id

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