A randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of Bifidobacterium lactis IDCC 4301 (B.lactis Fit®) on reducing body fat

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0012043

Enrollment

100

Registered

2026-05-27

Start date

2025-03-11

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : Bifidobacterium lactis IDCC 4301 (B.lactis Fit®) or placebo Capsules, 500 mg/capsule, 1 capsule/time, Once a day, Oral administration for 12 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Adults aged 19 to 60 years 2) Individuals with a BMI of 25 kg/m2 to 29.9 kg/m2 3) Individuals who voluntarily agree to participate in the study and sign the informed consent form

Exclusion criteria

Exclusion criteria: 1) Individuals who had weight loss of 10% or more during the 3 months before the screening visit 2) Individuals who continuously used medications or health functional foods affecting body weight or body fat reduction within 1 month before enrollment - Medications: anti-obesity drugs, hypoglycemic agents, insulin, diuretics, antidepressants, corticosteroids, antiepileptic drugs, oral contraceptives, or other drugs affecting energy metabolism, blood glucose, appetite, gastrointestinal activity, or body weight 3) Individuals who underwent surgery or a procedure for weight loss within the past year 4) Individuals who participated in a commercial or non-commercial weight loss program within the past 3 months 5) Patients with uncontrolled hypertension (systolic blood pressure 160 mmHg or higher, or diastolic blood pressure 100 mmHg or higher) 6) Individuals with fasting glucose of 126 mg/dL or higher, diagnosed with diabetes, or current use of oral hypoglycemic agents or insulin 7) Individuals with AST, ALT, or Cr exceeding twice the normal range 8) Pregnant or lactating women, or women planning pregnancy within the next 6 months 9) Individuals with hypersensitivity to the test product or its ingredients, or allergy to specific ingredients 10) Individuals diagnosed with or treated for cancer within the past 5 years 11) Individuals with a history of surgery within the past 6 months 12) Individuals diagnosed with autoimmune disease or thyroid disease 13) Individuals diagnosed with severe cerebrovascular disease (e.g., cerebral infarction or hemorrhage) or heart disease (e.g., angina, myocardial infarction, heart failure, or arrhythmia) 14) Individuals diagnosed with chronic gastrointestinal disorder 15) Individuals diagnosed with mental illness, central nervous system disorder, alcohol dependence, or eating disorder 16) Individuals currently taking oral contraceptives 17) Individuals who participated in another clinical trial or human application trial within 1 month before this study 18) Individuals unable to read or with limited reading ability 19) Individuals judged by the principal investigator to be unsuitable for participation

Design outcomes

Primary

Measure	Time frame
Change in body fat measured by Dual Energy X-ray Absorptiometry (DEXA)	—

Secondary

Measure	Time frame
Change in body fat measured by Bioelectrical Impedance Analysis (BIA);Blood markers (TC, LDL-C, HDL-C, TG, Adiponectin, Leptin, Fasting glucose, Fasting insulin, HOMA-IR);Waist circumference, hip circumference, and waist-to-hip ratio (WHR)	—

Countries

Korea, Republic of

Contacts

Public ContactMinkyung Bok

Research Institute of Medical Nutrition

yoccobbong03@naver.com+82-2-969-7715

Outcome results