Evaluation of the Body Slimming Effect of TCI904

Evaluation of the Body Slimming Effect of Lactobacillus Delbrueckii Ssp. Bulgaricus TCI904

To assess the efficacy of Lactobacillus delbrueckii ssp. bulgaricus TCI904 on body slimming

Study Overview

• Status: Completed
• Conditions: Body Weight; Metabolic Syndrome
• Intervention / Treatment: Dietary supplement: Placebo sachet; Dietary supplement: TCI904 sachet

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan
    • China Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo sachet	Dietary supplement: Placebo sachet; consume 1 sachet per day
Experimental: TCI904 sachet	Dietary supplement: TCI904 sachet; consume 1 sachet per day; Other Names: Lactobacillus delbrueckii ssp. bulgaricus TCI904

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of body weight (kg)	The body weight was assessed by Body Composition Monitor	Week 0, week 12
The change of BMI (kg/m^2)	The BMI was assessed by Body Composition Monitor	Week 0, week 12
The change of body fat rate (%)	The body fat rate was assessed by Body Composition Monitor	Week 0, week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of total cholesterol	Fasting venous blood was sampled to measure concentrations of total cholesterol	Week 0, week 12
The change of triglyceride	Fasting venous blood was sampled to measure concentrations of triglyceride	Week 0, week 12
The change of HDL-C	Fasting venous blood was sampled to measure concentrations of HDL-C	Week 0, week 12
The change of LDL-C	Fasting venous blood was sampled to measure concentrations of LDL-C	Week 0, week 12
The change of blood glucose	Fasting venous blood was sampled to measure concentrations of glucose	Week 0, week 12
The change of C-reactive protein	Fasting venous blood was sampled to measure concentrations of C-reactive protein	Week 0, week 12
The change of insulin	Fasting venous blood was sampled to measure concentrations of insulin	Week 0, week 12
The change of HbA1c	Fasting venous blood was sampled to measure concentrations of HbA1c	Week 0, week 12
The change of TNF-alpha	Fasting venous blood was sampled to measure concentrations of TNF-alpha	Week 0, week 12
The change of Hypoxia-inducible factor 1-alpha (HIF-1alpha)	Fasting venous blood was sampled to measure concentrations of HIF-1alpha	Week 0, week 12
The change of cyclooxygenase-2 (COX-2)	Fasting venous blood was sampled to measure concentrations of COX-2	Week 0, week 12
The change of Matrix metalloproteinase (MMP)	Fasting venous blood was sampled to measure concentrations of MMP	Week 0, week 12
The change of aspartate aminotransferase	Fasting venous blood was sampled to measure concentrations of aspartate aminotransferase	Week 0, week 12
The change of alanine aminotransferase	Fasting venous blood was sampled to measure concentrations of alanine aminotransferase	Week 0, week 12
The change of albumin	Fasting venous blood was sampled to measure concentrations of albumin	Week 0, week 12
The change of creatine	Fasting venous blood was sampled to measure concentrations of creatine	Week 0, week 12
The change of blood urea nitrogen (BUN)	Fasting venous blood was sampled to measure concentrations of BUN	Week 0, week 12

Collaborators and Investigators

• Sponsor: TCI Co., Ltd.
• Investigators: Principal Investigator: Yang-Chang Wu, China Medical University, China

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: March 27, 2023
• First Submitted That Met QC Criteria: March 27, 2023
• First Posted (Actual): April 10, 2023

Study Record Updates

• Last Update Posted (Actual): April 10, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Metabolic Syndrome; Body Weight
• Other Study ID Numbers: CMUH110-REC2-070

Drug and device information, study documents

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