The Effect of Lactobacillus Delbrueckii Subsp. Bulgaricus on Human's Weight Reduction

China Medical University

Status: Completed

Conditions: Overweight and Obesity

Treatments: Dietary Supplement: Probiotics; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06244186

CMUH110-REC2-070

Details and patient eligibility

About

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

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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36 participants in 2 patient groups, including a placebo group

Probiotics

Experimental group

Description:

Take one packet (6 grams) of powder orally once daily. The probiotics contain fruit juice powder (strawberry, cranberry, black currant), sucralose, anhydrous citric acid, maltodextrin, silicon dioxide, and Lactobacillus delbrueckii subsp. Bulgaricus.

Treatment:

Dietary Supplement: Probiotics

Placebo

Placebo Comparator group

Description:

Placebo contains fruit juice powder (strawberry, cranberry, black currant), sucralose, anhydrous citric acid, maltodextrin, and silicon dioxide.

Treatment:

Dietary Supplement: Placebo