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

NCT ID: NCT06244186

Last Updated: 2024-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-10
• Study Completion Date: 2023-11-03

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.

Conditions

Overweight and Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Probiotics

Intervention Type: DIETARY_SUPPLEMENT

Probiotics contains a probiotic known as Lactobacillus delbrueckii subsp. Bulgaricus, a key bacterium utilized in the production of yogurt, cheeses, and various naturally fermented products. Studies suggest that the metabolites of Lactobacillus bulgaricus can enhance immunity and digestion, reduce the risk of infection, and lower blood cholesterol levels. The composition of probiotics has been developed by TCI CO., Ltd.

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo is provided by TCI CO., Ltd.

Interventions

Probiotics

Probiotics contains a probiotic known as Lactobacillus delbrueckii subsp. Bulgaricus, a key bacterium utilized in the production of yogurt, cheeses, and various naturally fermented products. Studies suggest that the metabolites of Lactobacillus bulgaricus can enhance immunity and digestion, reduce the risk of infection, and lower blood cholesterol levels. The composition of probiotics has been developed by TCI CO., Ltd.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo is provided by TCI CO., Ltd.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TCI Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kuo-Chin Huang, PhD

Role: STUDY_DIRECTOR

China Medical University Hospital

Locations

China Medical University Hospital

Taichung, , Taiwan

Countries

Taiwan

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CMUH110-REC2-070

Identifier Type: -

Identifier Source: org_study_id