Clinical trial NCT05459909: The Effect of Synbiotic and Diet Modification Among Overweight or Obese Hong Kong Chinese
Official 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: Obesity
Overweight
Synbiotic
Diet
Metabolic dysfunction
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-07-15
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in body weight at week 8 compared with baseline
timeFrame: Week 0, 8
measure: Change in Body Mass Index (BMI) at week 8 compared with baseline
timeFrame: Week 0, 8
measure: Change in body fat percentage at week 8 compared with baseline
timeFrame: Week 0, 8
Secondary outcomes:
measure: Change in fasting glucose at week 8 compared with baseline
timeFrame: Week 0, 8
measure: Change in fasting insulin at week 8 compared with baseline
timeFrame: Week 0, 8
measure: Changes in fasting lipids at week 8 compared with baseline
timeFrame: Week 0, 8
measure: 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
timeFrame: Week 0, 8
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Hoi Shan Kwan, PhD
role: STUDY_CHAIR
affiliation: Chinese University of Hong Kong
name: Peter Chi Keung Cheung, PhD
role: STUDY_DIRECTOR
affiliation: Chinese University of Hong Kong
name: Susana Lauw, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese University of Hong Kong
name: Nelson Kei, BSc
role: PRINCIPAL_INVESTIGATOR
References: