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Evaluation of the Body Slimming Effect of TCI904

Primary Purpose

Body Weight, Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Placebo sachet
TCI904 sachet
Sponsored by
TCI Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Body Weight

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age ≥ 20 BMI ≥ 23 or male body fat ≥ 25%, female body fat ≥ 30%. History of Atherosclerotic cardiovascular disease (including cerebrovascular disease, coronary heart disease, peripheral vascular disease) or Type 2 diabetes or have any of the following factors: Age Men ≥ 45 years, Women ≥ 55 years or amenorrhea, hypertension, hyperlipidemia (total cholesterol > 200 mg/dL or low-density lipoprotein cholesterol LDL-C > 130 mg/dL or triglyceride TG > 130 mg/dL), high-density lipoprotein cholesterol HDL-C < 40 mg/dL. If people have routinely taken drugs for lowering blood sugar, blood pressure or blood lipids, there is no significant dose change within three months (variation ≤ 20%). Volunteers who are willing to participate in and complete the trial plan after explaining by the researchers, and sign the consent form. Exclusion Criteria: History of diabetic ketoacidosis. Medical records documented cerebrovascular disease, acute myocardial infarction or coronary artery bypass surgery or placement of coronary artery stents or peripheral vascular disease within the last 6 months. Known acute infectious illness within the past month with > 7 days of antibiotics. Known short-term use of steroids, NSAIDs, anti-rejection drugs, interferon, immunomodulators or changes in long-term doses due to any factors in the past month. Have used any weight loss drugs (including Orlistate, Lorcaserin, liraglutide) within the past three months. History of any cancer in the past 5 years or still receiving cancer treatment. Patients with abnormal liver function (GOT or GPT greater than 3 times the upper limit of normal) or known cirrhosis. Patients with abnormal kidney function (eGFR < 30 mL/min/1.73 m^2). Patients with a history of alcoholism. Have participated in any other interventional clinical research within the last month. Pregnant and lactating women. Known history of allergy to the test substance. Patients who are judged inappropriate by the trial host.

Sites / Locations

  • China Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo sachet

TCI904 sachet

Arm Description

Outcomes

Primary Outcome Measures

The change of body weight (kg)
The body weight was assessed by Body Composition Monitor
The change of BMI (kg/m^2)
The BMI was assessed by Body Composition Monitor
The change of body fat rate (%)
The body fat rate was assessed by Body Composition Monitor

Secondary Outcome Measures

The change of total cholesterol
Fasting venous blood was sampled to measure concentrations of total cholesterol
The change of triglyceride
Fasting venous blood was sampled to measure concentrations of triglyceride
The change of HDL-C
Fasting venous blood was sampled to measure concentrations of HDL-C
The change of LDL-C
Fasting venous blood was sampled to measure concentrations of LDL-C
The change of blood glucose
Fasting venous blood was sampled to measure concentrations of glucose
The change of C-reactive protein
Fasting venous blood was sampled to measure concentrations of C-reactive protein
The change of insulin
Fasting venous blood was sampled to measure concentrations of insulin
The change of HbA1c
Fasting venous blood was sampled to measure concentrations of HbA1c
The change of TNF-alpha
Fasting venous blood was sampled to measure concentrations of TNF-alpha
The change of Hypoxia-inducible factor 1-alpha (HIF-1alpha)
Fasting venous blood was sampled to measure concentrations of HIF-1alpha
The change of cyclooxygenase-2 (COX-2)
Fasting venous blood was sampled to measure concentrations of COX-2
The change of Matrix metalloproteinase (MMP)
Fasting venous blood was sampled to measure concentrations of MMP
The change of aspartate aminotransferase
Fasting venous blood was sampled to measure concentrations of aspartate aminotransferase
The change of alanine aminotransferase
Fasting venous blood was sampled to measure concentrations of alanine aminotransferase
The change of albumin
Fasting venous blood was sampled to measure concentrations of albumin
The change of creatine
Fasting venous blood was sampled to measure concentrations of creatine
The change of blood urea nitrogen (BUN)
Fasting venous blood was sampled to measure concentrations of BUN

Full Information

First Posted
March 27, 2023
Last Updated
March 27, 2023
Sponsor
TCI Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05805488
Brief Title
Evaluation of the Body Slimming Effect of TCI904
Official Title
Evaluation of the Body Slimming Effect of Lactobacillus Delbrueckii Ssp. Bulgaricus TCI904
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

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 efficacy of Lactobacillus delbrueckii ssp. bulgaricus TCI904 on body slimming

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Weight, Metabolic Syndrome

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo sachet
Arm Type
Placebo Comparator
Arm Title
TCI904 sachet
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo sachet
Intervention Description
consume 1 sachet per day
Intervention Type
Dietary Supplement
Intervention Name(s)
TCI904 sachet
Other Intervention Name(s)
Lactobacillus delbrueckii ssp. bulgaricus TCI904
Intervention Description
consume 1 sachet per day
Primary Outcome Measure Information:
Title
The change of body weight (kg)
Description
The body weight was assessed by Body Composition Monitor
Time Frame
Week 0, week 12
Title
The change of BMI (kg/m^2)
Description
The BMI was assessed by Body Composition Monitor
Time Frame
Week 0, week 12
Title
The change of body fat rate (%)
Description
The body fat rate was assessed by Body Composition Monitor
Time Frame
Week 0, week 12
Secondary Outcome Measure Information:
Title
The change of total cholesterol
Description
Fasting venous blood was sampled to measure concentrations of total cholesterol
Time Frame
Week 0, week 12
Title
The change of triglyceride
Description
Fasting venous blood was sampled to measure concentrations of triglyceride
Time Frame
Week 0, week 12
Title
The change of HDL-C
Description
Fasting venous blood was sampled to measure concentrations of HDL-C
Time Frame
Week 0, week 12
Title
The change of LDL-C
Description
Fasting venous blood was sampled to measure concentrations of LDL-C
Time Frame
Week 0, week 12
Title
The change of blood glucose
Description
Fasting venous blood was sampled to measure concentrations of glucose
Time Frame
Week 0, week 12
Title
The change of C-reactive protein
Description
Fasting venous blood was sampled to measure concentrations of C-reactive protein
Time Frame
Week 0, week 12
Title
The change of insulin
Description
Fasting venous blood was sampled to measure concentrations of insulin
Time Frame
Week 0, week 12
Title
The change of HbA1c
Description
Fasting venous blood was sampled to measure concentrations of HbA1c
Time Frame
Week 0, week 12
Title
The change of TNF-alpha
Description
Fasting venous blood was sampled to measure concentrations of TNF-alpha
Time Frame
Week 0, week 12
Title
The change of Hypoxia-inducible factor 1-alpha (HIF-1alpha)
Description
Fasting venous blood was sampled to measure concentrations of HIF-1alpha
Time Frame
Week 0, week 12
Title
The change of cyclooxygenase-2 (COX-2)
Description
Fasting venous blood was sampled to measure concentrations of COX-2
Time Frame
Week 0, week 12
Title
The change of Matrix metalloproteinase (MMP)
Description
Fasting venous blood was sampled to measure concentrations of MMP
Time Frame
Week 0, week 12
Title
The change of aspartate aminotransferase
Description
Fasting venous blood was sampled to measure concentrations of aspartate aminotransferase
Time Frame
Week 0, week 12
Title
The change of alanine aminotransferase
Description
Fasting venous blood was sampled to measure concentrations of alanine aminotransferase
Time Frame
Week 0, week 12
Title
The change of albumin
Description
Fasting venous blood was sampled to measure concentrations of albumin
Time Frame
Week 0, week 12
Title
The change of creatine
Description
Fasting venous blood was sampled to measure concentrations of creatine
Time Frame
Week 0, week 12
Title
The change of blood urea nitrogen (BUN)
Description
Fasting venous blood was sampled to measure concentrations of BUN
Time Frame
Week 0, week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age ≥ 20 BMI ≥ 23 or male body fat ≥ 25%, female body fat ≥ 30%. History of Atherosclerotic cardiovascular disease (including cerebrovascular disease, coronary heart disease, peripheral vascular disease) or Type 2 diabetes or have any of the following factors: Age Men ≥ 45 years, Women ≥ 55 years or amenorrhea, hypertension, hyperlipidemia (total cholesterol > 200 mg/dL or low-density lipoprotein cholesterol LDL-C > 130 mg/dL or triglyceride TG > 130 mg/dL), high-density lipoprotein cholesterol HDL-C < 40 mg/dL. If people have routinely taken drugs for lowering blood sugar, blood pressure or blood lipids, there is no significant dose change within three months (variation ≤ 20%). Volunteers who are willing to participate in and complete the trial plan after explaining by the researchers, and sign the consent form. Exclusion Criteria: History of diabetic ketoacidosis. Medical records documented cerebrovascular disease, acute myocardial infarction or coronary artery bypass surgery or placement of coronary artery stents or peripheral vascular disease within the last 6 months. Known acute infectious illness within the past month with > 7 days of antibiotics. Known short-term use of steroids, NSAIDs, anti-rejection drugs, interferon, immunomodulators or changes in long-term doses due to any factors in the past month. Have used any weight loss drugs (including Orlistate, Lorcaserin, liraglutide) within the past three months. History of any cancer in the past 5 years or still receiving cancer treatment. Patients with abnormal liver function (GOT or GPT greater than 3 times the upper limit of normal) or known cirrhosis. Patients with abnormal kidney function (eGFR < 30 mL/min/1.73 m^2). Patients with a history of alcoholism. Have participated in any other interventional clinical research within the last month. Pregnant and lactating women. Known history of allergy to the test substance. Patients who are judged inappropriate by the trial host.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yang-Chang Wu
Organizational Affiliation
China Medical University, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
China Medical University
City
Taichung
Country
Taiwan

12. IPD Sharing Statement

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Evaluation of the Body Slimming Effect of TCI904

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