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

NCT04492605 | Active Not Recruiting

• 1 other identifier: 201912029RSA
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (8)

• The change of body fat mass

  The body fat mass (kg) was assessed by InBody770

  Weeks 0, 4 and 8

• The change of Triglyceride

  Venous blood was sampled to measure concentrations of Triglyceride

  Weeks 0, 4 and 8

• The change of Total cholestrol

  Venous blood was sampled to measure concentrations of Total cholestrol

  Weeks 0, 4 and 8

• The change of HDL-cholestrol

  Venous blood was sampled to measure concentrations of HDL-cholestrol

  Weeks 0, 4 and 8

• The change of LDL-cholestrol

  Venous blood was sampled to measure concentrations of LDL-cholestrol

  Weeks 0, 4 and 8

• The change of body mass index (BMI)

  BMI is a measurement of a person's leanness or corpulence based on their height and weight, and is intended to quantify tissue mass.The body mass index (BMI, kg/m\^2) and body mass (kg) were assessed by InBody770.

  Weeks 0, 4 and 8

• The change of body fat percentage

  The body fat percentage (%) was assessed by InBody770.

  Weeks 0, 4 and 8

• The change of visceral fat

  The visceral fat (10 cm\^2) was assessed by InBody770.

  Weeks 0, 4 and 8

Secondary Outcomes (7)

• The change of fasting glycemia

  Weeks 0, 4 and 8

• The change of aspartate aminotransferase

  Weeks 0, 4 and 8

• The change of alanine aminotransferase

  Weeks 0, 4 and 8

• The change of albumin

  Weeks 0, 4 and 8

• The change of creatine

  Weeks 0, 4 and 8

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

TCI378 Probiotics

EXPERIMENTAL

TCI378 Probiotics

Dietary Supplement: TCI378 Probiotics

TCI507 Probiotics

EXPERIMENTAL

TCI507 Probiotics

Dietary Supplement: TCI507 Probiotics

Interventions

Placebo DIETARY_SUPPLEMENT

consume 1 capsule per day for 2 months

Placebo

TCI378 Probiotics DIETARY_SUPPLEMENT

consume 1 capsule per day for 2 months

TCI378 Probiotics

TCI507 Probiotics DIETARY_SUPPLEMENT

consume 1 capsule per day for 2 months

TCI507 Probiotics

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• 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.
• BMI ≥ 24 or male body fat ≥ 25%, female body fat ≥ 30%.
• Those who are not pregnant and are willing to cooperate with contraception during the trial period.
• 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).

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 diseases, alcohol or drug abuse, and other major organic diseases (according to medical history).
• No person who has undergone major surgery or bariatric surgery (according to medical history).
• 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).

Sponsors & Collaborators

• TCI Co., Ltd.: lead

Study Sites (2)

National Taiwan University Hospital

Taipei, Taiwan, 114, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

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

Study Officials

• LIOU JYH-MING

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2020
• First Posted: July 30, 2020
• Study Start: March 9, 2022
• Primary Completion: October 16, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)