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

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06244186
• Other study ID #: CMUH110-REC2-070
• Status: Completed
• Phase: N/A
• Start date: September 10, 2021
• Est. completion date: November 3, 2023

Study information

• Verified date: February 2024
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 3, 2023
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity
• Weight Loss

Intervention

Dietary Supplement:
• 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.
• Placebo
Placebo is provided by TCI CO., Ltd.

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

Sponsors (2)

Lead Sponsor	Collaborator
China Medical University Hospital	TCI Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight	Comparing the changes between Day 0 and Day 84	84 days
Primary	Body fat	Comparing the changes between Day 0 and Day 84	84 days
Primary	BMI	Comparing the changes between Day 0 and Day 84	84 days
Secondary	ALT and AST (U/L) in Blood composition	Comparing the changes in ALT and AST (alanine aminotransferase, aspartate aminotransferase) in the blood between Day 0 and Day 84	84 days
Secondary	CRE, BUN and GLU-AC (mg/dL) in Blood composition	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	84 days
Secondary	Changes in glycated hemoglobin	Comparing the changes in hemoglobin A1c between Day 0 and Day 84.	84 days
Secondary	Changes in CHOL, TG, HDL and LDL-C (mg/dL) in Blood composition	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.	84 days