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

NCT ID: NCT04910620

Last Updated: 2021-06-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-15
• Study Completion Date: 2024-06-14

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.

Conditions

Weight Reduction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Placebo without TCI378 and TCI507

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo only

TCI378

probiotics TCI378 (Lactobacillus plantarum TCI378)

Group Type: EXPERIMENTAL

TCI378

Intervention Type: DRUG

TCI378 (Lactobacillus plantarum TCI378)

TCI507

TCI507 (Lactobacillus plantarum TCI507)

Group Type: EXPERIMENTAL

TCI507

Intervention Type: DRUG

TCI507 (Lactobacillus plantarum TCI507)

Interventions

Placebo

Placebo only

Intervention Type: DRUG

TCI378

TCI378 (Lactobacillus plantarum TCI378)

Intervention Type: DRUG

TCI507

TCI507 (Lactobacillus plantarum TCI507)

Intervention Type: DRUG

Eligibility 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).

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Jyh-Ming Liou

Role: CONTACT

jyhmingliou@gmail.com

23123456 ext. 63541

Other Identifiers

201912029RSA

Identifier Type: -

Identifier Source: org_study_id