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

NCT04910620 | Unknown Phase 4

• 1 other identifier: 201912029RSA
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

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

  8 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo without TCI378 and TCI507

Drug: Placebo

TCI378

EXPERIMENTAL

probiotics TCI378 (Lactobacillus plantarum TCI378)

Drug: TCI378

TCI507

EXPERIMENTAL

TCI507 (Lactobacillus plantarum TCI507)

Drug: TCI507

Interventions

Placebo DRUG

Placebo only

Placebo

TCI378 DRUG

TCI378 (Lactobacillus plantarum TCI378)

TCI378

TCI507 DRUG

TCI507 (Lactobacillus plantarum TCI507)

TCI507

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults between the ages of 20 and 65 who are willing to sign the consent form of the subject.
• For those with BMI ≥ 24, men's body fat ≥ 25%, women's body fat ≥ 30%
• Those who are not pregnant and are willing to cooperate with contraception during the trial period.
• 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).

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jyh-Ming Liou

CONTACT

23123456; jyhmingliou@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 2, 2021
• Study Start: June 15, 2021
• Primary Completion: June 14, 2024
• Study Completion: June 14, 2024
• Last Updated: June 2, 2021

Record last verified: 2021-05