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

NCT06653101 | Completed

• 1 other identifier: WK2024014
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overweight or Obesity

Outcome Measures

Primary Outcomes (3)

• Changes in serum concentrations of glucagon-like peptide-1 (GLP-1) before and after intervention.

  Detected by enzyme-linked immunosorbent assay (ELISA).

  week 0 and week 8

• Changes in serum concentrations of leptin before and after intervention.

  Detected by enzyme-linked immunosorbent assay (ELISA).

  week 0 and week 8

• Changes in serum concentrations of peptide YY before and after intervention.

  Detected by enzyme-linked immunosorbent assay (ELISA).

  week 0 and week 8

Study Arms (2)

Probiotic group

EXPERIMENTAL

Each Akk11 capsule contained 350 mg inulin and 175 mg FOS (2:1 ratio), together with 1 × 10¹⁰ AFU of viable Akk11 cells. Dosage: 3 capsules per day.

Dietary Supplement: Probiotic

Placebo group

PLACEBO COMPARATOR

Each placebo capsule contained 350 mg inulin and 175 mg FOS (2:1 ratio). Dosage: 3 capsules per day.

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

The trial phase of this study lasted 8 weeks, and each patient will make 3 visits (week 0, week 4, week 8)

Probiotic group

Placebo DIETARY_SUPPLEMENT

The trial phase of this study lasted 8 weeks, and each patient will make 3 visits (week 0, week 4, week 8)

Placebo group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Wecare Probiotics Co., Ltd.: lead

Study Sites (1)

Fei Xu

Zhengzhou, None Selected, 210095, China

Location

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 22, 2024
• Study Start: October 20, 2024
• Primary Completion: December 5, 2024
• Study Completion: March 20, 2025
• Last Updated: November 18, 2025

Record last verified: 2024-12

Locations

CN (1)