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Weight Loss Effects and Health Impacts of Probiotic Supplementation in Overweight Women: A Randomized, Double-Blind, Positive-Controlled Trial

Weight Loss Effects and Health Impacts of Probiotic Supplementation in Overweight Women: A Randomized, Double-Blind, Positive-Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128587
Enrollment
Unknown
Registered
2026-07-22
Start date
2026-07-25
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Obese

Interventions

Multi-strain Probiotics Group:Multi-strain Probiotics
Probiotic group:Bifidobacterium adolescentis HY03596
B420 Positive Control Group:Probiotic B420

Sponsors

Qilu Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Female subjects aged 18–65 years; 2.Body mass index (BMI) ranging from 24.0 to 28.0 kg/m^²; 3.Waist-to-hip ratio >= 0.83; 4.No intake of any products that may affect body weight or gut microbiota (e.g., probiotics, prebiotics, dietary supplements) or medications (e.g., antihypertensives, lipid-lowering drugs, weight-loss drugs) within the past month; 5.Willing to receive and complete all study-related examinations, including finger-prick blood sampling and venous blood collection; 6.Voluntary participation, capable of understanding study procedures and signing the informed consent form;

Exclusion criteria

Exclusion criteria: 1.Organic intestinal diseases (e.g., colon cancer, inflammatory bowel disease, short bowel syndrome, etc.); 2.Subjects diagnosed with diabetes mellitus; 3.Use of antibiotics, antifungals or probiotic preparations within the past month; 4.Administration of any drugs or injections that may directly affect body weight within the past three months (e.g., orlistat, GLP-1 receptor agonists such as liraglutide/semaglutide, metformin used for weight loss, other anti-obesity medications, etc.); 5.Concomitant severe cardiac, cerebral, renal or hepatic diseases (e.g., heart failure, stroke, chronic renal insufficiency, active liver disease, etc.); 6.Individuals with chronic excessive alcohol consumption (>20 g per day) or a history of alcohol abuse; 7.Subjects with psychiatric or cognitive disorders who are unable to comply with trial procedures; 8.Long-term or continuous use of medications known to markedly disrupt gut microbiota homeostasis (e.g., long-term systemic glucocorticoids, immunosuppressants, chronic maintenance broad-spectrum antibiotics, etc.); 9.Pregnant women or those planning to become pregnant within the next six months;

Design outcomes

Primary

MeasureTime frame
anthropometric parameters;

Secondary

MeasureTime frame
quality of life indicators;safety indicators;mood state indicators;biochemical indicators;

Countries

China

Contacts

Public ContactLixiang Li

Qilu Hospital of Shandong University

lilixiang@sdu.edu.cn+86 531 82165323

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026