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

Weight Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04492605
• Other study ID #: 201912029RSA
• Status: Recruiting
• Phase: N/A
• Start date: March 9, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: TCI Co., Ltd.
• Contact: Hung YU-JUN
• Phone: 0934173838
• Email: nneder34[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: December 31, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Body Weight
• Weight Loss

Intervention

Dietary Supplement:
• Placebo
consume 1 capsule per day for 2 months
• TCI378 Probiotics
consume 1 capsule per day for 2 months
• TCI507 Probiotics
consume 1 capsule per day for 2 months

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
TCI Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of body fat mass	The body fat mass (kg) was assessed by InBody770	Weeks 0, 4 and 8
Primary	The change of Triglyceride	Venous blood was sampled to measure concentrations of Triglyceride	Weeks 0, 4 and 8
Primary	The change of Total cholestrol	Venous blood was sampled to measure concentrations of Total cholestrol	Weeks 0, 4 and 8
Primary	The change of HDL-cholestrol	Venous blood was sampled to measure concentrations of HDL-cholestrol	Weeks 0, 4 and 8
Primary	The change of LDL-cholestrol	Venous blood was sampled to measure concentrations of LDL-cholestrol	Weeks 0, 4 and 8
Primary	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
Primary	The change of body fat percentage	The body fat percentage (%) was assessed by InBody770.	Weeks 0, 4 and 8
Primary	The change of visceral fat	The visceral fat (10 cm^2) was assessed by InBody770.	Weeks 0, 4 and 8
Secondary	The change of fasting glycemia	Venous blood was sampled to measure concentrations of fasting glycemia	Weeks 0, 4 and 8
Secondary	The change of aspartate aminotransferase	Venous blood was sampled to measure concentrations of aspartate aminotransferase	Weeks 0, 4 and 8
Secondary	The change of alanine aminotransferase	Venous blood was sampled to measure concentrations of alanine aminotransferase	Weeks 0, 4 and 8
Secondary	The change of albumin	Venous blood was sampled to measure concentrations of albumin	Weeks 0, 4 and 8
Secondary	The change of creatine	Venous blood was sampled to measure concentrations of creatine	Weeks 0, 4 and 8
Secondary	The change of uric acid	Venous blood was sampled to measure concentrations of uric acid	Weeks 0, 4 and 8
Secondary	The change of white blood cell	Venous blood was sampled to measure concentrations of white blood cell	Weeks 0, 4 and 8