Evaluation of the Body Slimming Effect of TCI904
Study Details
Study Description
Brief Summary
To assess the efficacy of Lactobacillus delbrueckii ssp. bulgaricus TCI904 on body slimming
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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:
|
Outcome Measures
Primary Outcome Measures
- The change of body weight (kg) [Week 0, week 12]
The body weight 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
- The change of body fat rate (%) [Week 0, week 12]
The body fat rate was assessed by Body Composition Monitor
Secondary Outcome Measures
- The change of total cholesterol [Week 0, week 12]
Fasting venous blood was sampled to measure concentrations of total cholesterol
- The change of triglyceride [Week 0, week 12]
Fasting venous blood was sampled to measure concentrations of triglyceride
- The change of HDL-C [Week 0, week 12]
Fasting venous blood was sampled to measure concentrations of HDL-C
- The change of LDL-C [Week 0, week 12]
Fasting venous blood was sampled to measure concentrations of LDL-C
- The change of blood glucose [Week 0, week 12]
Fasting venous blood was sampled to measure concentrations of glucose
- 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 insulin [Week 0, week 12]
Fasting venous blood was sampled to measure concentrations of insulin
- The change of HbA1c [Week 0, week 12]
Fasting venous blood was sampled to measure concentrations of HbA1c
- The change of TNF-alpha [Week 0, week 12]
Fasting venous blood was sampled to measure concentrations of TNF-alpha
- 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 cyclooxygenase-2 (COX-2) [Week 0, week 12]
Fasting venous blood was sampled to measure concentrations of COX-2
- The change of Matrix metalloproteinase (MMP) [Week 0, week 12]
Fasting venous blood was sampled to measure concentrations of MMP
- The change of aspartate aminotransferase [Week 0, week 12]
Fasting venous blood was sampled to measure concentrations of aspartate aminotransferase
- The change of alanine aminotransferase [Week 0, week 12]
Fasting venous blood was sampled to measure concentrations of alanine aminotransferase
- The change of albumin [Week 0, week 12]
Fasting venous blood was sampled to measure concentrations of albumin
- The change of creatine [Week 0, week 12]
Fasting venous blood was sampled to measure concentrations of creatine
- The change of blood urea nitrogen (BUN) [Week 0, week 12]
Fasting venous blood was sampled to measure concentrations of BUN
Eligibility Criteria
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.
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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%).
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Volunteers who are willing to participate in and complete the trial plan after explaining by the researchers, and sign the consent form.
Exclusion Criteria:
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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.
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Known acute infectious illness within the past month with > 7 days of antibiotics.
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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.
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Have used any weight loss drugs (including Orlistate, Lorcaserin, liraglutide) within the past three months.
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History of any cancer in the past 5 years or still receiving cancer treatment.
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Patients with abnormal liver function (GOT or GPT greater than 3 times the upper limit of normal) or known cirrhosis.
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Patients with abnormal kidney function (eGFR < 30 mL/min/1.73 m^2).
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Patients with a history of alcoholism.
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Have participated in any other interventional clinical research within the last month.
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Pregnant and lactating women.
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Known history of allergy to the test substance.
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Patients who are judged inappropriate by the trial host.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | China Medical University | Taichung | Taiwan |
Sponsors and Collaborators
- TCI Co., Ltd.
Investigators
- Principal Investigator: Yang-Chang Wu, China Medical University, China
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CMUH110-REC2-070