Overview

The Evaluation of TCI378 and TCI507 Probiotics on Weight-lowering Efficacy in Adults

Status:
Not yet recruiting
Trial end date:
2024-06-14
Target enrollment:
0
Participant gender:
All
Summary
Obesity is a serious global public health issue. Many reports have showed that the use of appropriate probiotics can bring benefits to the health of the host and promote the balance of gut microbiota. Clinical experimental data show that the supplement of probiotics can help regulate gut function and weight control, and etc. TCI378 (Lactobacillus plantarum TCI378) is a probiotic extracted from Korean kimchi, and TCI507 (Lactobacillus plantarum TCI507) is a probiotic extracted from the oranges peels. These two strains of probiotics have been verified by in vitro experiments to have the effect of hydrolyzing bile salts, inhibition of the production of fat cells. Therefore, we want to evaluate whether the probiotics TCI308 and TCI507 have effects on reduction of body weight.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Taiwan University Hospital
Criteria
Inclusion Criteria:

1. Adults between the ages of 20 and 65 who are willing to sign the consent form of the
subject.

2. For those with BMI ≥ 24, men's body fat ≥ 25%, women's body fat ≥ 30%

3. Those who are not pregnant and are willing to cooperate with contraception during the
trial period.

4. Those who have no history of cardiovascular disease, organ transplantation, epilepsy
or convulsions, liver and kidney disease, malignant tumors, endocrine disease, mental
disease, alcohol or drug abuse, and 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 illness, alcohol or drug abuse, and other major organic
diseases (according to medical history).

2. Those who had undergone major surgery or bariatric surgery (according to medical
history).

3. Currently or within 3 months before participating in the screening, those subjects
used drugs that can affect body fat or increase weight significantly, such as systemic
corticosteroids, tricyclic antidepressants, atypical psychiatric drugs, and mood
stability Drugs (according to medical history).