Body Weight, Metabolic Syndrome
Conditions
Brief summary
To assess the efficacy of Lactobacillus delbrueckii ssp. bulgaricus TCI904 on body slimming
Interventions
DIETARY_SUPPLEMENTPlacebo sachet
consume 1 sachet per day
DIETARY_SUPPLEMENTTCI904 sachet
consume 1 sachet per day
Sponsors
TCI Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 total cholesterol | Week 0, week 12 | Fasting venous blood was sampled to measure concentrations of total cholesterol |
| 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 |
| 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 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 |
Countries
Taiwan
Outcome results
None listed