Pasteurized Akkermansia Muciniphila for Weight Management and Energy Metabolism in Overweight and Obesity
Probiotc
+ Placebo
Body Weight+5
+ Nutrition Disorders
+ Nutritional and Metabolic Diseases
Treatment Study
Summary
Study start date: March 15, 2025
Actual date on which the first participant was enrolled.This clinical trial explores the potential benefits of using pasteurized Akkermansia muciniphila Akk11, a type of killed bacteria, to help manage weight and improve energy metabolism in adults who are overweight or obese. The study aims to see if these capsules can positively affect various body measurements such as weight, BMI, body fat percentage, waist-hip ratio, wrist circumference, visceral fat area, and basal metabolic rate. Additionally, it investigates whether these capsules can improve blood lipid levels, which include total cholesterol, LDL, HDL, and triglycerides. This research is important because finding effective ways to manage weight and improve metabolic health can significantly enhance quality of life and reduce health risks associated with obesity. Participants in the study will take capsules of either the pasteurized Akkermansia muciniphila Akk11 or a placebo. The effects will be measured by monitoring changes in body composition and blood lipid levels over time. This involves evaluating various parameters like body fat and cholesterol levels, which are critical indicators of metabolic health. Although the study does not specify the phase, it is interventional, meaning it involves active treatment to assess the outcomes. The process is designed to ensure safety and efficacy, providing valuable information on the potential role of this bacterial supplement in managing obesity and metabolic health.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.61 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
The School of Food and Bioengineering, Henan University of Science and Technolog
Luoyang, ChinaOpen The School of Food and Bioengineering, Henan University of Science and Technolog in Google Maps