Evaluation of the Body Slimming Effect of TCI904

Study Overview
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Brief Summary
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To assess the efficacy of Lactobacillus delbrueckii ssp. bulgaricus TCI904 on body slimming

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

Conditions
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Body Weight, Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: Placebo sachet
* Dietary Supplement: TCI904 sachet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo sachet<br> | Dietary Supplement: Placebo sachet<br>* consume 1 sachet per day<br>|
| Experimental: TCI904 sachet<br> | Dietary Supplement: TCI904 sachet<br>* consume 1 sachet per day<br>* Other names: Lactobacillus delbrueckii ssp. bulgaricus TCI904;|

What is the study measuring?
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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 |