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

Not Applicable

Recruiting

• Conditions: Weight Loss
• Interventions: Dietary Supplement: TCI507 Probiotics; Dietary Supplement: Placebo; Dietary Supplement: TCI378 Probiotics

• Registration Number: NCT04492605
• Lead Sponsor: TCI Co., Ltd.

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-07-24
• Study First Submitted QC: 2020-07-27
• Study First Posted: 2020-07-30
• Study Start: 2022-03-09
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10
• Primary Completion: 2025-03-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 96

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TCI507 Probiotics	TCI507 Probiotics	TCI507 Probiotics
Placebo	Placebo	Placebo
TCI378 Probiotics	TCI378 Probiotics	TCI378 Probiotics

Primary Outcome Measures

Name	Time	Method
The change of body fat percentage	Weeks 0, 4 and 8	The body fat percentage (%) was assessed by InBody770.
The change of LDL-cholestrol	Weeks 0, 4 and 8	Venous blood was sampled to measure concentrations of LDL-cholestrol
The change of visceral fat	Weeks 0, 4 and 8	The visceral fat (10 cm\^2) was assessed by InBody770.
The change of body fat mass	Weeks 0, 4 and 8	The body fat mass (kg) was assessed by InBody770
The change of body mass index (BMI)	Weeks 0, 4 and 8	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.
The change of HDL-cholestrol	Weeks 0, 4 and 8	Venous blood was sampled to measure concentrations of HDL-cholestrol
The change of Triglyceride	Weeks 0, 4 and 8	Venous blood was sampled to measure concentrations of Triglyceride
The change of Total cholestrol	Weeks 0, 4 and 8	Venous blood was sampled to measure concentrations of Total cholestrol

Secondary Outcome Measures

Name	Time	Method
The change of fasting glycemia	Weeks 0, 4 and 8	Venous blood was sampled to measure concentrations of fasting glycemia
The change of alanine aminotransferase	Weeks 0, 4 and 8	Venous blood was sampled to measure concentrations of alanine aminotransferase
The change of albumin	Weeks 0, 4 and 8	Venous blood was sampled to measure concentrations of albumin
The change of white blood cell	Weeks 0, 4 and 8	Venous blood was sampled to measure concentrations of white blood cell
The change of aspartate aminotransferase	Weeks 0, 4 and 8	Venous blood was sampled to measure concentrations of aspartate aminotransferase
The change of creatine	Weeks 0, 4 and 8	Venous blood was sampled to measure concentrations of creatine
The change of uric acid	Weeks 0, 4 and 8	Venous blood was sampled to measure concentrations of uric acid

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan