Clinical trial NCT06244186: The Effect of Lactobacillus Delbrueckii Subsp. Bulgaricus on Human's Weight Reduction
Official title: The Effect of Lactobacillus Delbrueckii Subsp. Bulgaricus on Human's Weight Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: Lactobacillus delbrueckii subsp. Bulgaricus
weight reduction
health care
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
Collaborators: name: TCI Co., Ltd.
First posted: 2024-02-06
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Participants were randomly assigned to either the placebo or probiotics group, receiving continuous administration for 12 weeks. Measurements of weight, BMI, and body fat were taken on days 0, 28, 56, and 84 of the treatment period. Additionally, 15 mL of fasting blood was drawn on both the first and 84th day.
Primary purpose: OTHER

Brief summary: To evaluate the improvement in weight, body fat, and BMI after adding probiotics as a once-daily therapy for 84 days in overweight individuals.

Detailed description: The study product contains Lactobacillus delbrueckii subsp. Bulgaricus at a concentration of 1x10\^8 CFU in each 100 mg. The objective of this study is to evaluate the benefits of probiotics as an add-on therapy in overweight individuals by assessing the improvements in weight, body fat, and BMI after adding probiotics as a once-daily therapy for 84 days.

A randomized, two-regimen, placebo-controlled, parallel design is employed in this study, where each subject will receive either probiotics or a placebo. The add-on study product will be administered once daily for 84 days. The benefits will be assessed at baseline and subsequently on study days 28, 56, and 84, focusing on parameters such as weight, body fat, and BMI.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 20 years old
* Overweight (BMI ≥ 23) or body fat percentage ≥ 25% for males and ≥ 30% for females
* Having any of the following risk factors: Atherosclerotic cardiovascular disease, type 2 diabetes, age ≥ 45 years for males, ≥ 55 years for females or postmenopausal, hypertension, dyslipidemia (total cholesterol \> 200 mg/dL or low-density lipoprotein cholesterol \> 130 mg/dL or triglycerides \> 130 mg/dL), high-density lipoprotein cholesterol \< 40 mg/dL
* If routinely taking medication for lowering blood glucose, blood pressure, or lipid levels, there should not be significant dosage changes within the past three months
* Being willing to participate after receiving an explanation from the physician, completing the trial plan, and signing the consent form

Exclusion Criteria:

* History of diabetic ketoacidosis
* Medical records indicating the occurrence of cerebrovascular disease, acute myocardial infarction, coronary artery bypass surgery, placement of coronary artery stents, or peripheral vascular disease within the last 6 months
* Occurrence of acute infectious diseases within the last month and antibiotic use for \> 7 days
* Short-term use of steroids, NSAIDs, immunosuppressive drugs, interferons, immunomodulators, or any changes in the dose of long-term medications within the last month
* Use of any weight-loss drugs in the last three months (including Orlistat, Lorcaserin, and liraglutide)
* History of any cancer or undergoing cancer treatment in the past 5 years
* Abnormal liver function (GOT or GPT greater than 3 times the normal upper limit) or liver cirrhosis
* Impaired kidney function (eGFR \< 30 mL/min/1.73 m2)
* History of alcohol abuse
* Participation in any other interventional clinical research within the last month
* Pregnant and breastfeeding women
* History of allergy to the investigational product
* Participants deemed unsuitable for inclusion by the principal investigator

Primary outcomes:
measure: Body weight
timeFrame: 84 days
measure: Body fat
timeFrame: 84 days
measure: BMI
timeFrame: 84 days
Secondary outcomes:
measure: ALT and AST (U/L) in Blood composition
timeFrame: 84 days
measure: CRE, BUN and GLU-AC (mg/dL) in Blood composition
timeFrame: 84 days
measure: Changes in glycated hemoglobin
timeFrame: 84 days
measure: Changes in CHOL, TG, HDL and LDL-C (mg/dL) in Blood composition
timeFrame: 84 days
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: China Medical University Hospital
name: Kuo-Chin Huang, PhD
role: STUDY_DIRECTOR
References: