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

NCT06244186 | Completed

• 1 other identifier: CMUH110-REC2-070
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Keywords

Lactobacillus delbrueckii subsp. Bulgaricus; weight reduction; health care

Outcome Measures

Primary Outcomes (3)

• Body weight

  Comparing the changes between Day 0 and Day 84

  84 days

• Body fat

  Comparing the changes between Day 0 and Day 84

  84 days

• BMI

  Comparing the changes between Day 0 and Day 84

  84 days

Secondary Outcomes (4)

• ALT and AST (U/L) in Blood composition

  84 days

• CRE, BUN and GLU-AC (mg/dL) in Blood composition

  84 days

• Changes in glycated hemoglobin

  84 days

• Changes in CHOL, TG, HDL and LDL-C (mg/dL) in Blood composition

  84 days

Study Arms (2)

Probiotics

EXPERIMENTAL

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.

Dietary Supplement: Probiotics

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Probiotics 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.

Probiotics

Placebo DIETARY_SUPPLEMENT

Placebo is provided by TCI CO., Ltd.

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• China Medical University Hospital: lead
• TCI Co., Ltd.: collaborator

Study Sites (1)

China Medical University Hospital

Taichung, 404327, Taiwan

Location

MeSH Terms

Conditions

Overweight; Obesity; Weight Loss

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Kuo-Chin Huang, PhD

  China Medical University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: February 6, 2024
• Study Start: September 10, 2021
• Primary Completion: November 1, 2022
• Study Completion: November 3, 2023
• Last Updated: February 6, 2024

Record last verified: 2024-02

Locations

TW (1)