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A prospective interventional study evaluating the effects of a mixture containing pasteurized AKKermansia Muciniphila on body weight in a Chinese population

A prospective interventional study evaluating the effects of a mixture containing pasteurized AKKermansia Muciniphila on body weight in a Chinese population

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600117559
Enrollment
Unknown
Registered
2026-01-26
Start date
2026-01-31
Completion date
Unknown
Last updated
2026-03-16

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

Conditions

Body Weight in Chinese Population

Interventions

Trial group:Take one capsule containing heat-inactivated Akkermansia muciniphila MucT orally once daily with dinner for 90 consecutive days.

Sponsors

The international peace maternity and child health hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Before the trial, sign the informed consent form and have a thorough understanding of the trial content, process and possible adverse reactions. 2.Age: 18-70 years old (including 18 and 70); 3.Body Mass Index (BMI) between 25-30 (including 25 and 30); 4.log10 AKK ng/g fecal DNA<0;

Exclusion criteria

Exclusion criteria: 1. Women who are planning to conceive, are pregnant, or are breastfeeding; 2. Have undergone any type of weight loss surgery; 3. Have used any medication within the last 6 months that may control blood sugar and insulin (such as metformin) or plan to use medication during the study period; 4. Using any weight-loss medication within the past three months or planning to use medication during the study period; 5. Have participated in, are currently participating in, or plan to participate in other clinical trials within the past three months during the research period; 6. In the past three months, the consumption of dietary supplements included omega-3 fatty acids, probiotics, prebiotics, phytosterols/sterols, or those planned to be consumed during the study period; 7. Within the past three months, have received antibiotic treatment or are planning to use medication during the study period; 8. Weight fluctuation of >=5kg in the past 3 months; 9. Suffering from malignant tumors; 10. There are cardiovascular, immune, respiratory, gastrointestinal, biliary, kidney and urinary systems, nervous and musculoskeletal systems, mental disorders, thyroid diseases, or there are severe endocrine, liver, and infectious diseases and complications; 11. Creatinine >=2^1 times the upper limit of the standard; Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) >=3^1 times the upper limit of the standard; 12. Alcohol consumption (>2 cups per day); 13. Smoking more than 10 cigarettes per day; 14. Those who are allergic to probiotic products, tea products, or have a history of drug allergy or allergic diseases; 15. Any condition that, in the judgment of the researcher, hinders participation.

Design outcomes

Primary

MeasureTime frame
Weight;

Secondary

MeasureTime frame
Other indicators (including fasting glucose, insulin, HbA1c, HOMA-Index, total cholesterol, low-density lipoprotein cholesterol (LDL), high-density lipoprotein cholesterol (HDL), triglycerides, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT), total bilirubin (Tbil), high-sensitivity C-reactive protein (hsCRP), waist circumference, BMI, blood pressure, Depression-Anxiety-Stress Scale (DASS-21), Gastrointestinal Symptom;

Countries

China

Contacts

Public ContactSun Wenguang

The international peace maternity and child health hospital

sunwenguang68@126.com+86 21 64070434

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 20, 2026