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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04910620
Enrollment
96
Registered
2021-06-02
Start date
2021-06-15
Completion date
2024-06-14
Last updated
2021-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Weight Reduction

Brief 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.

Interventions

DRUGPlacebo

Placebo only

DRUGTCI378

TCI378 (Lactobacillus plantarum TCI378)

DRUGTCI507

TCI507 (Lactobacillus plantarum TCI507)

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frame
To evaluate whether the probiotics TCI378 (Lactobacillus plantarum TCI378) and TCI507 (Lactobacillus plantarum TCI507) have effect on reduction of body weight.8 weeks

Contacts

Primary ContactJyh-Ming Liou
jyhmingliou@gmail.com23123456

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026