Status:
NOT_YET_RECRUITING
Effects of Synbiotics on Obesity
Lead Sponsor:
Leeuwenhoek Laboratories Co. Ltd.
Conditions:
Obesity
Eligibility:
All Genders
20-60 years
Phase:
PHASE2
Brief Summary
Synbiotics are a combination of probiotics and prebiotics that can promote the survival of probiotics in the gut. Probiotics utilize prebiotics to produce various metabolites beneficial to human healt...
Eligibility Criteria
Inclusion
- Age between 20-60 years.
- Body weight ≥ 50 kg.
- Body Mass Index (BMI) ≥ 24.
- Body fat percentage ≥ 30% for females or ≥ 25% for males.
- Waist circumference ≥ 80 cm for females or ≥ 90 cm for males.
- No remarkable medical history within the past six months.
- Willing to comply with the nutritional instructions during the study period.
- Willing to report body weight once a week.
- Willing to report dietary and activity records.
- Willing to comply with the instruction of "not using" other products containing probiotics or enzymes (excluding yogurt and yogurt drinks).
- Willing to sign Clinical Trial Informed Consent Form before the trial.
Exclusion
- Pregnant or breastfeeding.
- Without statutory notifiable diseases, including HIV, syphilis, hepatitis B, hepatitis C, etc.
- Judged by a physician to have "secondary obesity" (obesity caused by endocrine disorders or metabolic abnormalities).
- Presence of endocrine disorders, hypertension, diabetes, cerebrovascular diseases, cardiovascular diseases, liver diseases, kidney diseases, gastrointestinal diseases, or mental disorders.
- Currently taking medications for lipid-lowering, blood sugar control, or weight loss.
- Currently taking antibiotic-related medications.
- Determined unsuitable for participation in this trial by a physician.
Key Trial Info
Start Date :
October 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06578143
Start Date
October 15 2024
End Date
March 1 2025
Last Update
October 9 2024
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