Gut Microbiota-Based Clinical Study of Akkermansia Supplementation for Overweight and Obesity

Korábbi kezelés

• Use of weight-loss medications within the past 3 months, including GLP-1 receptor agonists, orlistat, or metformin used for weight management;
• Previous bariatric surgery or planned bariatric surgery during the study period;

Más betegség

• Type 1 diabetes mellitus or type 2 diabetes mellitus requiring insulin therapy;
• Uncontrolled hypertension, severe cardiovascular or cerebrovascular diseases, severe hepatic or renal dysfunction, malignant tumors, immunodeficiency, or active infections;
• Gastrointestinal diseases that may significantly affect gut microbiota, including inflammatory bowel disease, short bowel syndrome, chronic diarrhea, severe constipation, or other clinically significant gastrointestinal disorders;
• Known allergy to any component of the study products;
• Any condition considered unsuitable for participation by the investigator.

Egyéb

• Use of antibiotics, probiotics, prebiotics, synbiotics, postbiotics, or other microbiota-modulating products within the past 3 months;
• Participation in commercial weight-loss programs or intensive lifestyle interventions within the past 3 months;
• Pregnancy, lactation, or planning to become pregnant during the study;
• Participation in other clinical studies that may affect study outcomes;
• For participants entering the second-phase randomized controlled trial, high baseline Akkermansia abundance (Akkermansia abundance ≥1.5%) identified by gut microbiota testing;

• Healthy Controls:
  • Aged 18-60 years, any sex;
  • BMI between 18.5 and 24.9 kg/m²;
  • Body weight change <5% within the past 3 months;
  • No obesity-related metabolic diseases, including type 2 diabetes mellitus, impaired glucose tolerance, hypertension, dyslipidemia, or nonalcoholic fatty liver disease;
  • No use of antibiotics, probiotics, prebiotics, synbiotics, postbiotics, weight-loss medications, glucocorticoids, or immunosuppressive agents within the past 3 months;
  • No gastrointestinal diseases that may significantly affect gut microbiota;
  • No severe diseases involving the cardiovascular, cerebrovascular, hepatic, renal, hematological, or endocrine systems, and no history of malignant tumors;
  • Not pregnant, lactating, or planning pregnancy;
  • Willing to participate voluntarily, provide fecal and blood samples and clinical data, and sign written informed consent.
• Overweight/Obese Participants:
  • Aged 18-60 years, any sex;
  • BMI between 25.0 and 34.9 kg/m²;
  • Body weight change <5% within the past 3 months;
  • Willing to maintain relatively stable dietary habits, physical activity, and daily routines during the study period;
  • Able to complete the 12-week intervention and 24-week follow-up;
  • Willing to provide fecal and blood samples and clinical data;
  • Willing to participate voluntarily and sign written informed consent.

A regiszterben nem jelölt feltételek

• This study includes healthy controls and participants with overweight or obesity. Eligibility criteria are as follows: