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

The Chinese University of Hong Kong

Status: Active, not recruiting

Conditions: Obesity

Treatments: Dietary Supplement: Synbiotic supplementation; Behavioral: Dietary intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05459909

SYN-DIET-OB-RCT

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 20 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

Synbiotic supplementation

Experimental group

Description:

Synbiotic supplementation

Treatment:

Dietary Supplement: Synbiotic supplementation

Dietary intervention

Experimental group

Description:

Dietary intervention

Treatment:

Behavioral: Dietary intervention

Synbiotic supplementation & dietary intervention

Experimental group

Description:

Synbiotic supplementation \& dietary intervention

Treatment:

Dietary Supplement: Synbiotic supplementation

Behavioral: Dietary intervention