Effect of Akkermansia Muciniphila Akk11 on Metabolic and Gut Health in Overweight and Obese Subjects

Wecare Probiotics

Status: Completed

Conditions: Overweight or Obesity

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Probiotic

Study type: Interventional

Funder types: Industry

Identifiers

NCT06653101

WK2024014

Details and patient eligibility

About

To assess the efficacy and safety of the use of probiotics as a food supplement compared to placebo in regulating body metabolism and gut microbiota in overweight or obese subjects.

Enrollment: 110 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. 18-45 years old;
2. BMI ≥ 24 kg/m2 or men with a body fat percentage of ≥ 25% and women with a body fat percentage of ≥ 30%；
3. Normal liver function indexes;
4. Willing to complete study-related questionnaires and diaries and complete all clinical visits.

Exclusion criteria

1. Those who have been diagnosed with high uric acid or gout are not recommended to participate in the test;
2. Psychiatric or neurological diseases, celiac disease, lactose intolerance, allergies;
3. Have the following diseases: irritable bowel syndrome, ulcerative colitis, fatty liver, liver cirrhosis, etc.;
4. Recently treated with antibiotics (i.e., < 3 months prior to the start of the study);
5. Participants who smoked more than 10 cigarettes per day were excluded;
6. It is not recommended to participate in other special circumstances, such as those who are allergic to probiotic products;
7. Pregnant and lactating women are not suitable for experiments.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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110 participants in 2 patient groups, including a placebo group

Probiotic group

Experimental group

Description:

Akk11 capsule, 30 billion AFU/day, before meals

Treatment:

Dietary Supplement: Probiotic

Placebo group

Placebo Comparator group

Description:

Placebo capsule, three capsules/day, before meals

Treatment:

Dietary Supplement: Placebo