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

Weight Reduction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04910620
• Other study ID #: 201912029RSA
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 15, 2021
• Est. completion date: June 14, 2024

Study information

• Verified date: May 2021
• Source: National Taiwan University Hospital
• Contact: Jyh-Ming Liou
• Phone: 23123456
• Email: jyhmingliou[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. completion date: June 14, 2024
• Est. primary completion date: June 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Body Weight
• Weight Loss
• Weight Reduction

Intervention

Drug:
• Placebo
Placebo only
• TCI378
TCI378 (Lactobacillus plantarum TCI378)
• TCI507
TCI507 (Lactobacillus plantarum TCI507)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate whether the probiotics TCI378 (Lactobacillus plantarum TCI378) and TCI507 (Lactobacillus plantarum TCI507) have effect on reduction of body weight.		8 weeks