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

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

Study Overview

• Status: Recruiting
• Conditions: Weight Loss
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: TCI378 Probiotics; Dietary supplement: TCI507 Probiotics

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 Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hung YU-JUN; Phone Number: 0934173838; Email: nneder34@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Hospital
    • Contact: chi fu chiang, phd; Email: Jimmy.Chiang@tci-bio.com
  • Taipei, Taiwan, 114
    • Recruiting
    • National Taiwan University Hospital
    • Contact: chi fu chiang, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; consume 1 capsule per day for 2 months
Experimental: TCI378 Probiotics	Dietary supplement: TCI378 Probiotics; consume 1 capsule per day for 2 months
Experimental: TCI507 Probiotics	Dietary supplement: TCI507 Probiotics; consume 1 capsule per day for 2 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: TCI Co., Ltd.
• Investigators: Principal Investigator: LIOU JYH-MING, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2022
• Primary Completion (Anticipated): December 30, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: July 24, 2020
• First Submitted That Met QC Criteria: July 27, 2020
• First Posted (Actual): July 30, 2020

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 14, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: 201912029RSA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No