Evaluating probiotics for weight loss in adults
The Evaluation of TCI378 and TCI507 Probiotics on Weight-lowering Efficacy in Adults
This study is testing whether two types of probiotics can help overweight adults lose weight over two months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 25 Years to 65 Years |
| Sex | All |
| Sponsor | TCI Co., Ltd. Industry-sponsored |
| Locations | 2 sites (Taipei and 1 other locations) |
| Trial ID | NCT04492605 on ClinicalTrials.gov |
What this trial studies
This clinical trial assesses the effectiveness of two probiotics, TCI378 and TCI507, in promoting weight loss among adults. It is a double-blind, randomized study where participants will consume the assigned probiotic or a placebo daily for two months. Overweight individuals, as determined by a physician, will be invited to participate, and their progress will be monitored through various assessments and questionnaires at each visit.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 20 to 65 with a BMI of 24 or higher or specific body fat percentages.
Not a fit: Patients with a history of significant medical conditions or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel probiotic-based approach to assist adults in achieving weight loss.
How similar studies have performed: While the use of probiotics for weight management is an emerging field, this specific combination of probiotics has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adults between the ages of 20 and 65 who are willing to sign the consent form of the subject. 2. BMI ≥ 24 or male body fat ≥ 25%, female body fat ≥ 30%. 3. Those who are not pregnant and are willing to cooperate with contraception during the trial period. 4. No history of cardiovascular disease, history of organ transplantation, history of epilepsy or convulsions, liver and kidney disease, malignant tumor, endocrine disease, mental disease, alcohol or drug abuse, or other major organic diseases (according to medical history). Exclusion Criteria: 1. Pregnant women, people with a history of cardiovascular disease, organ transplantation, epilepsy or convulsions, liver and kidney disease, malignant tumors, endocrine diseases, mental diseases, alcohol or drug abuse, and other major organic diseases (according to medical history). 2. No person who has undergone major surgery or bariatric surgery (according to medical history). 3. Drugs that affect body fat, waist circumference, or significantly increase weight, such as systemic corticosteroids, tricyclic antidepressants, atypical psychiatric drugs, and mood stability, have been used at present or within 3 months before participating in the screening Drugs (according to medical history).
Where this trial is running
Taipei and 1 other locations
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Principal investigator: Liou Jyh-Ming — National Taiwan University Hospital
- Study coordinator: Hung YU-JUN
- Email: nneder34@gmail.com
- Phone: 0934173838
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.