Clinical trial NCT05805488: Evaluation of the Body Slimming Effect of TCI904
Official title: Evaluation of the Body Slimming Effect of Lactobacillus Delbrueckii Ssp. Bulgaricus TCI904
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Weight
Metabolic Syndrome
Lead sponsor: TCI Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-04-10
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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


Eligibility 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.
* 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.

Primary outcomes:
measure: The change of body weight (kg)
timeFrame: Week 0, week 12
measure: The change of BMI (kg/m^2)
timeFrame: Week 0, week 12
measure: The change of body fat rate (%)
timeFrame: Week 0, week 12
Secondary outcomes:
measure: The change of total cholesterol
timeFrame: Week 0, week 12
measure: The change of triglyceride
timeFrame: Week 0, week 12
measure: The change of HDL-C
timeFrame: Week 0, week 12
measure: The change of LDL-C
timeFrame: Week 0, week 12
measure: The change of blood glucose
timeFrame: Week 0, week 12
measure: The change of C-reactive protein
timeFrame: Week 0, week 12
measure: The change of insulin
timeFrame: Week 0, week 12
measure: The change of HbA1c
timeFrame: Week 0, week 12
measure: The change of TNF-alpha
timeFrame: Week 0, week 12
measure: The change of Hypoxia-inducible factor 1-alpha (HIF-1alpha)
timeFrame: Week 0, week 12
measure: The change of cyclooxygenase-2 (COX-2)
timeFrame: Week 0, week 12
measure: The change of Matrix metalloproteinase (MMP)
timeFrame: Week 0, week 12
measure: The change of aspartate aminotransferase
timeFrame: Week 0, week 12
measure: The change of alanine aminotransferase
timeFrame: Week 0, week 12
measure: The change of albumin
timeFrame: Week 0, week 12
measure: The change of creatine
timeFrame: Week 0, week 12
measure: The change of blood urea nitrogen (BUN)
timeFrame: Week 0, week 12
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University
Study officials:
affiliation: China Medical University, China
name: Yang-Chang Wu
role: PRINCIPAL_INVESTIGATOR
References: