Evaluation of the Body Slimming Effect of TCI904

TCI

Status

Completed

Conditions

Body Weight

Metabolic Syndrome

Treatments

Dietary Supplement: TCI904 sachet

Dietary Supplement: Placebo sachet

Study type

Interventional

Funder types

Industry

Identifiers

CMUH110-REC2-070

Details and patient eligibility

About

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

Enrollment

36 patients

Sex

All

Ages

20+ years old

Volunteers

Accepts Healthy Volunteers

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.