Obesity
Conditions
Interventions
Trial Group 2:Subjects daily consume a mixed probiotic supplement containing Bifidobacterium longum CCFM1113 and Bifidobacterium adolescentis CCFM1386 at a specific dose (twice daily, with each dose c
Trial Group 2:Subjects receive a placebo that is identical in appearance and taste but contains no Bifidobacterium longum or other probiotics, to ensure the double-blind nature of the study.
Trial Group 1:Subjects daily consume a probiotic supplement containing Bifidobacterium longum CCFM1113 at a specific dose (twice daily, with each dose containing >=5×10^8 CFU). The supplement undergoe
Sponsors
Jinshan Branch of Shanghai Sixth People’s Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. According to the "Clinical Guidelines for Obesity Management (2024 Edition)," obesity is defined as a BMI (Body Mass Index) of 28 kg/m^2 or higher; a BMI of 24 kg/m^2 or higher is considered overweight; 2. Fasting blood glucose >= 5.6 mmol/L but = 7.8 mmol/L but = 5.7% but < 6.5%; 3. Age between 18 and 65 years, regardless of gender; 4. Female participants agree to use contraception during the trial period; 5. Capable of understanding and signing the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with secondary obesity, including causes such as hypothyroidism, Cushing’s syndrome, or long-term use of medications leading to obesity; 2. Patients with chronic diseases of the heart, brain, liver, or kidney requiring special dietary management or limiting physical activity; 3. Patients with rheumatic or autoimmune diseases, hematologic disorders, or a history of malignancy; 4. Pregnant or lactating women; 5. Individuals who are unable, unwilling, or refuse to comply with study requirements, including lifestyle modifications, follow-up visits, and participant responsibilities.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycemic metabolism indicators;Levels of inflammatory markers; | — |
Countries
China
Contacts
Public ContactJi Ye
Jinshan Branch of Shanghai Sixth People’s Hospital
Outcome results
None listed