Overweight and Obesity
Conditions
Keywords
Lactobacillus delbrueckii subsp. Bulgaricus, weight reduction, health care
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.
Interventions
DIETARY_SUPPLEMENTProbiotics
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.
DIETARY_SUPPLEMENTPlacebo
Placebo is provided by TCI CO., Ltd.
Sponsors
TCI Co., Ltd.
China Medical University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)
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.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| BMI | 84 days | Comparing the changes between Day 0 and Day 84 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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. |
Countries
Taiwan
Outcome results
None listed