Evaluation of the Body Slimming Effect of TCI904

Not Applicable

Completed

• Conditions: Metabolic Syndrome; Body Weight
• Interventions: Dietary Supplement: Placebo sachet; Dietary Supplement: TCI904 sachet

• Registration Number: NCT05805488
• Lead Sponsor: TCI Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-01
• Primary Completion: 2022-01-31
• Study Completion: 2022-12-31
• Status Verified: 2023-03
• Study First Submitted: 2023-03-27
• Study First Submitted QC: 2023-03-27
• Last Update Submitted: 2023-03-27
• Study First Posted: 2023-04-10
• Last Update Posted: 2023-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo sachet	Placebo sachet	-
TCI904 sachet	TCI904 sachet	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

China Medical University; 🇨🇳 Taichung, Taiwan