Evaluation of the Body Slimming Effect of TCI904

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05805488
• Other study ID #: CMUH110-REC2-070
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2023
• Source: TCI Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Metabolic Syndrome

Intervention

Dietary Supplement:
• Placebo sachet
consume 1 sachet per day
• TCI904 sachet
consume 1 sachet per day

Locations

Country	Name	City	State
Taiwan	China Medical University	Taichung

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 weight (kg)	The body weight was assessed by Body Composition Monitor	Week 0, week 12
Primary	The change of BMI (kg/m^2)	The BMI was assessed by Body Composition Monitor	Week 0, week 12
Primary	The change of body fat rate (%)	The body fat rate was assessed by Body Composition Monitor	Week 0, week 12
Secondary	The change of total cholesterol	Fasting venous blood was sampled to measure concentrations of total cholesterol	Week 0, week 12
Secondary	The change of triglyceride	Fasting venous blood was sampled to measure concentrations of triglyceride	Week 0, week 12
Secondary	The change of HDL-C	Fasting venous blood was sampled to measure concentrations of HDL-C	Week 0, week 12
Secondary	The change of LDL-C	Fasting venous blood was sampled to measure concentrations of LDL-C	Week 0, week 12
Secondary	The change of blood glucose	Fasting venous blood was sampled to measure concentrations of glucose	Week 0, week 12
Secondary	The change of C-reactive protein	Fasting venous blood was sampled to measure concentrations of C-reactive protein	Week 0, week 12
Secondary	The change of insulin	Fasting venous blood was sampled to measure concentrations of insulin	Week 0, week 12
Secondary	The change of HbA1c	Fasting venous blood was sampled to measure concentrations of HbA1c	Week 0, week 12
Secondary	The change of TNF-alpha	Fasting venous blood was sampled to measure concentrations of TNF-alpha	Week 0, week 12
Secondary	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
Secondary	The change of cyclooxygenase-2 (COX-2)	Fasting venous blood was sampled to measure concentrations of COX-2	Week 0, week 12
Secondary	The change of Matrix metalloproteinase (MMP)	Fasting venous blood was sampled to measure concentrations of MMP	Week 0, week 12
Secondary	The change of aspartate aminotransferase	Fasting venous blood was sampled to measure concentrations of aspartate aminotransferase	Week 0, week 12
Secondary	The change of alanine aminotransferase	Fasting venous blood was sampled to measure concentrations of alanine aminotransferase	Week 0, week 12
Secondary	The change of albumin	Fasting venous blood was sampled to measure concentrations of albumin	Week 0, week 12
Secondary	The change of creatine	Fasting venous blood was sampled to measure concentrations of creatine	Week 0, week 12
Secondary	The change of blood urea nitrogen (BUN)	Fasting venous blood was sampled to measure concentrations of BUN	Week 0, week 12