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

Not Applicable

Completed

• Conditions: Overweight and Obesity
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Probiotics

• Registration Number: NCT06244186
• Lead Sponsor: China Medical University Hospital

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.

Study Timeline

• Study Start: 2021-09-10
• Primary Completion: 2022-11-01
• Study Completion: 2023-11-03
• Study First Submitted: 2024-01-02
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-02
• Last Update Submitted: 2024-02-02
• Study First Posted: 2024-02-06
• Last Update Posted: 2024-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
BMI	84 days	Comparing the changes between Day 0 and Day 84
Body weight	84 days	Comparing the changes between Day 0 and Day 84
Body fat	84 days	Comparing the changes between Day 0 and Day 84

Secondary Outcome Measures

Name	Time	Method
Changes in CHOL, TG, HDL and LDL-C (mg/dL) in Blood composition	84 days	Comparing the changes in CHOL, TG, HDL, and LDL-C (cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol) between Day 0 and Day 84.
ALT and AST (U/L) in Blood composition	84 days	Comparing the changes in ALT and AST (alanine aminotransferase, aspartate aminotransferase) in the blood between Day 0 and Day 84
CRE, BUN and GLU-AC (mg/dL) in Blood composition	84 days	Comparing the changes in CRE, BUN, and GLU-AC (creatinine, blood urea nitrogen, fasting blood glucose) in the blood between Day 0 and Day 84
Changes in glycated hemoglobin	84 days	Comparing the changes in hemoglobin A1c between Day 0 and Day 84.

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung, Taiwan