NCT05459909

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jul 2020

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 15, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

July 19, 2022

Status Verified

July 1, 2022

Enrollment Period

3.5 years

First QC Date

July 7, 2022

Last Update Submit

July 15, 2022

Conditions

Obesity

Keywords

ObesityOverweightSynbioticDietMetabolic dysfunction

Outcome Measures

Primary Outcomes (3)

  • Change in body weight at week 8 compared with baseline

    Body weight in kilogram

    Week 0, 8

  • 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

  • Change in body fat percentage at week 8 compared with baseline

    Body fat percentage is assessed by bioimpedence

    Week 0, 8

Secondary Outcomes (4)

  • Change in fasting glucose at week 8 compared with baseline

    Week 0, 8

  • Change in fasting insulin at week 8 compared with baseline

    Week 0, 8

  • Changes in fasting lipids at week 8 compared with baseline

    Week 0, 8

  • 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

Study Arms (3)

Synbiotic supplementation

EXPERIMENTAL

Synbiotic supplementation

Dietary Supplement: Synbiotic supplementation

Dietary intervention

EXPERIMENTAL

Dietary intervention

Behavioral: Dietary intervention

Synbiotic supplementation & dietary intervention

EXPERIMENTAL

Synbiotic supplementation \& dietary intervention

Dietary Supplement: Synbiotic supplementationBehavioral: Dietary intervention

Interventions

Synbiotic supplementationDIETARY_SUPPLEMENT

Daily supplementation of synbiotic

Synbiotic supplementationSynbiotic supplementation & dietary intervention
Dietary interventionBEHAVIORAL

Increased fruits and vegetables consumption

Dietary interventionSynbiotic supplementation & dietary intervention

Eligibility Criteria

Age20 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Waist circumference ≥90cm in men and ≥80cm in women
  • BMI \>23.0kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Shatin, 000000, Hong Kong

Location

MeSH Terms

Conditions

ObesityOverweight

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • Hoi Shan Kwan, PhD

    Chinese University of Hong Kong

    STUDY CHAIR

  • Peter Chi Keung Cheung, PhD

    Chinese University of Hong Kong

    STUDY DIRECTOR

  • Susana Lauw, MSc

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

  • Nelson Kei, BSc

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 7, 2022

First Posted

July 15, 2022

Study Start

July 1, 2020

Primary Completion

December 31, 2023

Study Completion

July 31, 2024

Last Updated

July 19, 2022

Record last verified: 2022-07

Locations

HK(1)