Back to resultsThe Evaluation of TCI378 and TCI507 Probiotics on Weight-lowering Efficacy in Adults
Primary Purpose
Weight Loss
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Placebo
TCI378 Probiotics
TCI507 Probiotics
Sponsored by
About this trial
This is an interventional treatment trial for Weight Loss
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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).
Sites / Locations
- National Taiwan University HospitalRecruiting
- National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
TCI378 Probiotics
TCI507 Probiotics
Arm Description
Placebo
TCI378 Probiotics
TCI507 Probiotics
Outcomes
Primary Outcome Measures
The change of body fat mass
The body fat mass (kg) was assessed by InBody770
The change of Triglyceride
Venous blood was sampled to measure concentrations of Triglyceride
The change of Total cholestrol
Venous blood was sampled to measure concentrations of Total cholestrol
The change of HDL-cholestrol
Venous blood was sampled to measure concentrations of HDL-cholestrol
The change of LDL-cholestrol
Venous blood was sampled to measure concentrations of LDL-cholestrol
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.
The change of body fat percentage
The body fat percentage (%) was assessed by InBody770.
The change of visceral fat
The visceral fat (10 cm^2) was assessed by InBody770.
Secondary Outcome Measures
The change of fasting glycemia
Venous blood was sampled to measure concentrations of fasting glycemia
The change of aspartate aminotransferase
Venous blood was sampled to measure concentrations of aspartate aminotransferase
The change of alanine aminotransferase
Venous blood was sampled to measure concentrations of alanine aminotransferase
The change of albumin
Venous blood was sampled to measure concentrations of albumin
The change of creatine
Venous blood was sampled to measure concentrations of creatine
The change of uric acid
Venous blood was sampled to measure concentrations of uric acid
The change of white blood cell
Venous blood was sampled to measure concentrations of white blood cell
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04492605
Brief Title
The Evaluation of TCI378 and TCI507 Probiotics on Weight-lowering Efficacy in Adults
Official Title
The Evaluation of TCI378 and TCI507 Probiotics on Weight-lowering Efficacy in Adults
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TCI Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
TCI378 Probiotics
Arm Type
Experimental
Arm Description
TCI378 Probiotics
Arm Title
TCI507 Probiotics
Arm Type
Experimental
Arm Description
TCI507 Probiotics
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
consume 1 capsule per day for 2 months
Intervention Type
Dietary Supplement
Intervention Name(s)
TCI378 Probiotics
Intervention Description
consume 1 capsule per day for 2 months
Intervention Type
Dietary Supplement
Intervention Name(s)
TCI507 Probiotics
Intervention Description
consume 1 capsule per day for 2 months
Primary Outcome Measure Information:
Title
The change of body fat mass
Description
The body fat mass (kg) was assessed by InBody770
Time Frame
Weeks 0, 4 and 8
Title
The change of Triglyceride
Description
Venous blood was sampled to measure concentrations of Triglyceride
Time Frame
Weeks 0, 4 and 8
Title
The change of Total cholestrol
Description
Venous blood was sampled to measure concentrations of Total cholestrol
Time Frame
Weeks 0, 4 and 8
Title
The change of HDL-cholestrol
Description
Venous blood was sampled to measure concentrations of HDL-cholestrol
Time Frame
Weeks 0, 4 and 8
Title
The change of LDL-cholestrol
Description
Venous blood was sampled to measure concentrations of LDL-cholestrol
Time Frame
Weeks 0, 4 and 8
Title
The change of body mass index (BMI)
Description
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.
Time Frame
Weeks 0, 4 and 8
Title
The change of body fat percentage
Description
The body fat percentage (%) was assessed by InBody770.
Time Frame
Weeks 0, 4 and 8
Title
The change of visceral fat
Description
The visceral fat (10 cm^2) was assessed by InBody770.
Time Frame
Weeks 0, 4 and 8
Secondary Outcome Measure Information:
Title
The change of fasting glycemia
Description
Venous blood was sampled to measure concentrations of fasting glycemia
Time Frame
Weeks 0, 4 and 8
Title
The change of aspartate aminotransferase
Description
Venous blood was sampled to measure concentrations of aspartate aminotransferase
Time Frame
Weeks 0, 4 and 8
Title
The change of alanine aminotransferase
Description
Venous blood was sampled to measure concentrations of alanine aminotransferase
Time Frame
Weeks 0, 4 and 8
Title
The change of albumin
Description
Venous blood was sampled to measure concentrations of albumin
Time Frame
Weeks 0, 4 and 8
Title
The change of creatine
Description
Venous blood was sampled to measure concentrations of creatine
Time Frame
Weeks 0, 4 and 8
Title
The change of uric acid
Description
Venous blood was sampled to measure concentrations of uric acid
Time Frame
Weeks 0, 4 and 8
Title
The change of white blood cell
Description
Venous blood was sampled to measure concentrations of white blood cell
Time Frame
Weeks 0, 4 and 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hung YU-JUN
Phone
0934173838
Email
nneder34@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LIOU JYH-MING
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
114
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
chi fu chiang, Ph.D
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
chi fu chiang, phd
Email
Jimmy.Chiang@tci-bio.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Evaluation of TCI378 and TCI507 Probiotics on Weight-lowering Efficacy in Adults
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