Akkermansia Muciniphila Akk11 Impact on Obesity and Metabolic Health

Wecare Probiotics

Status: Enrolling

Conditions: Obesity

Treatments: Dietary Supplement: Maltodextrin; Dietary Supplement: Probiotic

Study type: Interventional

Funder types: Industry

Identifiers

NCT06728098

WK2024017

Details and patient eligibility

About

This is a randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of Akkermansia muciniphila Akk11 in adult obesity.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Male or female, aged 18-50 years
2. For healthy subjects: Must have a BMI between 18.5 and 24.9 kg/m2 and normal lipid profile (Cholesterol total <200 mg/dL; LDL-C <100 mg/dL; HDL-C ≥ 40 mg/dL; and triglyceride < 150 mg/dL)
3. For obese subjects: Must have a BMI ≥ 30 kg/m2, weight stable for at least 3 months (± 2 kg)
4. Subjects must be either of non-childbearing potential, or if of childbearing potential, must be abstinent or have practiced adequate contraception for the entire study
5. Subjects who have not smoked in the past 1 month prior to screening
6. Subjects or subject's legally acceptable representatives have the ability to comply with the trial protocol
7. Signed informed consent from the subject or subject's legally acceptable representatives (must be obtained before any study-related activities) -

Exclusion criteria

1. Male or female, aged 18-50 years
2. For healthy subjects: Must have a BMI between 18.5 and 24.9 kg/m2 and normal lipid profile (Cholesterol total <200 mg/dL; LDL-C <100 mg/dL; HDL-C ≥ 40 mg/dL; and triglyceride < 150 mg/dL)
3. For obese subjects: Must have a BMI ≥ 30 kg/m2, weight stable for at least 3 months (± 2 kg)
4. Subjects must be either of non-childbearing potential, or if of childbearing potential, must be abstinent or have practiced adequate contraception for the entire study
5. Subjects who have not smoked in the past 1 month prior to screening
6. Subjects or subject's legally acceptable representatives have the ability to comply with the trial protocol
7. Signed informed consent from the subject or subject's legally acceptable representatives (must be obtained before any study-related activities) -

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups, including a placebo group

Healthy Subjects on Probiotic

Active Comparator group

Description:

Healthy Subjects Receiving Probiotic Akk11: One probiotic Akkermansia muciniphila Akk11 capsule daily (1 billion AFU/capsule). Store in cool and dry place, without exposure to light.

Treatment:

Dietary Supplement: Probiotic

Obese Patients on Probiotic

Experimental group

Description:

Obese Patients Receiving Probiotic Akk11 : One probiotic Akkermansia muciniphila Akk11 capsule daily (1 billion AFU/capsule). Store in cool and dry place, without exposure to light.

Treatment:

Dietary Supplement: Probiotic

Obese Patients on Placebo

Placebo Comparator group

Description:

Obese Patients Receiving Placebo : Take 1 maltodextrin capsule every day. Store in cool and dry place, without exposure to light.

Treatment:

Dietary Supplement: Maltodextrin