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

NCT ID: NCT04492605

Last Updated: 2026-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-09

Study Completion Date

2026-05-31

Brief Summary

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To assess the evaluation of TCI378 and TCI507 probiotics on weight-lowering efficacy in adults

Detailed Description

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This is a double-blind and randomized study. Subjects are informed to consume the samples every day for 2 months. The person who is evaluated as overweight by the doctor will be invited to participate in this trial. The efficacy assessment items and questionnaires are collected at every visit of the trial.

Conditions

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Weight Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

consume 1 capsule per day for 2 months

TCI378 Probiotics

TCI378 Probiotics

Group Type EXPERIMENTAL

TCI378 Probiotics

Intervention Type DIETARY_SUPPLEMENT

consume 1 capsule per day for 2 months

TCI507 Probiotics

TCI507 Probiotics

Group Type EXPERIMENTAL

TCI507 Probiotics

Intervention Type DIETARY_SUPPLEMENT

consume 1 capsule per day for 2 months

Interventions

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Placebo

consume 1 capsule per day for 2 months

Intervention Type DIETARY_SUPPLEMENT

TCI378 Probiotics

consume 1 capsule per day for 2 months

Intervention Type DIETARY_SUPPLEMENT

TCI507 Probiotics

consume 1 capsule per day for 2 months

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

1. Adults between the ages of 20 and 65 who are willing to sign the consent form of the subject.
2. BMI ≥ 24 or male body fat ≥ 25%, female body fat ≥ 30%.
3. Those who are not pregnant and are willing to cooperate with contraception during the trial period.
4. No history of cardiovascular disease, history of organ transplantation, history of epilepsy or convulsions, liver and kidney disease, malignant tumor, endocrine disease, mental disease, alcohol or drug abuse, or 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 diseases, alcohol or drug abuse, and other major organic diseases (according to medical history).
2. No person who has undergone major surgery or bariatric surgery (according to medical history).
3. Drugs that affect body fat, waist circumference, or significantly increase weight, such as systemic corticosteroids, tricyclic antidepressants, atypical psychiatric drugs, and mood stability, have been used at present or within 3 months before participating in the screening Drugs (according to medical history).
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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TCI Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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LIOU JYH-MING

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, Taiwan, Taiwan

Site Status

National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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201912029RSA

Identifier Type: -

Identifier Source: org_study_id

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