Study Results
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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NOT_YET_RECRUITING
PHASE2
80 participants
INTERVENTIONAL
2024-10-15
2025-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Control
Placebo
Placebo is administered in capsules (500 mg each). Participants are instructed to take the capsules twice daily, with two capsules per dose, after meals. The duration of the intervention is 6 weeks.
Synbiotics
Synbiotics
Synbiotics is administered in capsules (500 mg each). Participants are instructed to take the capsules twice daily, with two capsules per dose, after meals. The duration of the intervention is 6 weeks.
Interventions
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Placebo
Placebo is administered in capsules (500 mg each). Participants are instructed to take the capsules twice daily, with two capsules per dose, after meals. The duration of the intervention is 6 weeks.
Synbiotics
Synbiotics is administered in capsules (500 mg each). Participants are instructed to take the capsules twice daily, with two capsules per dose, after meals. The duration of the intervention is 6 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
20 Years
60 Years
ALL
Yes
Sponsors
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Leeuwenhoek Laboratories Co. Ltd.
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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LL-IRB-2402
Identifier Type: -
Identifier Source: org_study_id
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