Gut Microbiota-Based Clinical Study of Akkermansia Supplementation for Overweight and Obesity
Overweight and obesity are common metabolic disorders associated with increased risks of diabetes, cardiovascular disease, and other health problems. The gut microbiota plays an important role in regulating metabolism, inflammation, and intestinal health. Akkermansia, a beneficial gut bacterium, has been associated with metabolic health and may have potential benefits for weight management.
This study aims to investigate the relationship between gut microbiota characteristics and overweight or obesity and to evaluate the efficacy and safety of Akkermansia supplementation in individuals with overweight or obesity.
The study consists of two stages. The first stage is an observational study comparing gut microbiota characteristics between healthy individuals and individuals with overweight or obesity. The second stage is a randomized, double-blind, placebo-controlled clinical trial in which eligible participants with overweight or obesity will receive either Akkermansia supplementation or placebo once daily for 12 weeks, followed by follow-up through Week 24.
The study will evaluate changes in body weight, metabolic health, gut microbiota characteristics, related metabolites, and safety outcomes. The findings may provide clinical evidence regarding the potential use of Akkermansia supplementation for the management of overweight and obesity.
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
This is a prospective, two-stage clinical study investigating the relationships among Akkermansia, gut microbiota characteristics, and overweight or obesity, and evaluating the efficacy and safety of Akkermansia supplementation in individuals with overweight or obesity.
The first stage is a cross-sectional observational study designed to compare gut microbiota characteristics between healthy controls and participants with overweight or obesity. This stage will evaluate differences in gut microbiota composition and explore associations between Akkermansia abundance, metabolic characteristics, and related clinical parameters. Participants with overweight or obesity who meet the eligibility criteria and are willing to provide additional informed consent may proceed to the second-stage randomized controlled trial.
The second stage is a randomized, double-blind, placebo-controlled clinical trial. Eligible participants with overweight or obesity will be randomly assigned to receive either Akkermansia supplementation or placebo. Participants in the Akkermansia group will receive oral Akkermansia supplementation once daily for 12 weeks, while participants in the placebo group will receive an identical placebo. All participants will receive standardized lifestyle guidance throughout the intervention period and will be followed through Week 24 to evaluate treatment effects and safety.
The primary objective of the intervention stage is to evaluate whether Akkermansia supplementation improves body weight outcomes compared with placebo. Secondary evaluations will include changes in anthropometric measurements, glucose and lipid metabolism parameters, inflammatory and gut barrier-related biomarkers, gut microbiota composition, gut microbiota-related and blood metabolites, appetite-related hormones, psychological status, gastrointestinal tolerance, and safety outcomes.
The total planned enrollment represents the number of unique participants rather than the sum of participants across the two study stages. Participants enrolled in the first observational stage may proceed to the randomized controlled trial if they meet the eligibility criteria and are willing to participate. Additional participants may be recruited to achieve the planned sample size for the randomized controlled trial.
This study will further explore the potential relationships among Akkermansia supplementation, gut microbiota regulation, metabolic improvement, and clinical outcomes in individuals with overweight or obesity. The findings may provide clinical evidence to support the development of microbiota-based strategies for weight management.
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Zhengyuan Xie, PhD
- Telefonszám: +86 13879182304
- E-mail: xzyxzy1230@163.com
Tanulmányi helyek
-
-
Jiangxi
-
Nanchang, Jiangxi, Kína, 330000
- No. 1, Minde Road, Donghu District, Nanchang University Second Affiliated Hospital
-
Kapcsolatba lépni:
- Kaige Zhang, PhD
- Telefonszám: +86 1875401615
- E-mail: zkg1997@126.com
-
-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
This study includes healthy controls and participants with overweight or obesity. Eligibility criteria are as follows:
Inclusion Criteria:
-
Healthy Controls:
- Aged 18-60 years, any sex;
- BMI between 18.5 and 24.9 kg/m²;
- Body weight change <5% within the past 3 months;
- No obesity-related metabolic diseases, including type 2 diabetes mellitus, impaired glucose tolerance, hypertension, dyslipidemia, or nonalcoholic fatty liver disease;
- No use of antibiotics, probiotics, prebiotics, synbiotics, postbiotics, weight-loss medications, glucocorticoids, or immunosuppressive agents within the past 3 months;
- No gastrointestinal diseases that may significantly affect gut microbiota;
- No severe diseases involving the cardiovascular, cerebrovascular, hepatic, renal, hematological, or endocrine systems, and no history of malignant tumors;
- Not pregnant, lactating, or planning pregnancy;
- Willing to participate voluntarily, provide fecal and blood samples and clinical data, and sign written informed consent.
-
Overweight/Obese Participants:
- Aged 18-60 years, any sex;
- BMI between 25.0 and 34.9 kg/m²;
- Body weight change <5% within the past 3 months;
- Willing to maintain relatively stable dietary habits, physical activity, and daily routines during the study period;
- Able to complete the 12-week intervention and 24-week follow-up;
- Willing to provide fecal and blood samples and clinical data;
- Willing to participate voluntarily and sign written informed consent.
Exclusion Criteria:
- Use of antibiotics, probiotics, prebiotics, synbiotics, postbiotics, or other microbiota-modulating products within the past 3 months;
- Use of weight-loss medications within the past 3 months, including GLP-1 receptor agonists, orlistat, or metformin used for weight management;
- Participation in commercial weight-loss programs or intensive lifestyle interventions within the past 3 months;
- Previous bariatric surgery or planned bariatric surgery during the study period;
- Type 1 diabetes mellitus or type 2 diabetes mellitus requiring insulin therapy;
- Uncontrolled hypertension, severe cardiovascular or cerebrovascular diseases, severe hepatic or renal dysfunction, malignant tumors, immunodeficiency, or active infections;
- Gastrointestinal diseases that may significantly affect gut microbiota, including inflammatory bowel disease, short bowel syndrome, chronic diarrhea, severe constipation, or other clinically significant gastrointestinal disorders;
- Pregnancy, lactation, or planning to become pregnant during the study;
- Known allergy to any component of the study products;
- Participation in other clinical studies that may affect study outcomes;
- For participants entering the second-phase randomized controlled trial, high baseline Akkermansia abundance (Akkermansia abundance ≥1.5%) identified by gut microbiota testing;
- Any condition considered unsuitable for participation by the investigator.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Négyszeres
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Kísérleti: Akkermansia Supplementation Group
Participants with overweight or obesity will receive oral Akkermansia supplementation once daily for 12 weeks. The intervention aims to evaluate the effects of Akkermansia supplementation on body weight, metabolic parameters, gut microbiota characteristics, related metabolites, and safety outcomes. Participants will be followed through Week 24 to assess treatment effects and safety. |
Akkermansia supplementation will be administered orally once daily for 12 weeks to participants with overweight or obesity. All participants will receive standardized lifestyle guidance throughout the intervention period. Treatment effects and safety will be assessed through Week 24. |
|
Placebo Comparator: Placebo Supplementation Group
Participants with overweight or obesity will receive a placebo once daily for 12 weeks. The placebo will have an appearance, color, odor, packaging, and administration method identical to those of the Akkermansia supplement. Participants will be followed through Week 24 to assess treatment effects and safety. |
The placebo will be administered orally once daily for 12 weeks to participants with overweight or obesity. It will be identical to the Akkermansia supplement in appearance, color, odor, packaging, and administration method. All participants will receive standardized lifestyle guidance throughout the intervention period. Treatment effects and safety will be assessed through Week 24. |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Percentage Change in Body Weight from Baseline at Week 12
Időkeret: Baseline and Week 12
|
Percentage change in body weight from baseline to Week 12, calculated as [(body weight at Week 12 - body weight at baseline) / body weight at baseline] × 100. The percentage change will be compared between the Akkermansia supplementation group and the placebo group. |
Baseline and Week 12
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Change in Body Mass Index from Baseline
Időkeret: Baseline, Weeks 4, 8, 12, 18, and 24.
|
Change in body mass index (BMI), calculated as body weight in kilograms divided by height in meters squared, from baseline to each follow-up visit. Results will be reported in kg/m². |
Baseline, Weeks 4, 8, 12, 18, and 24.
|
|
Change in Waist Circumference from Baseline
Időkeret: Baseline, Weeks 4, 8, 12, 18, and 24.
|
Change in waist circumference from baseline at each follow-up visit. Waist circumference will be measured using the standardized study procedure and reported in centimeters. |
Baseline, Weeks 4, 8, 12, 18, and 24.
|
|
Change in Body Fat Percentage from Baseline
Időkeret: Baseline, Weeks 12 and 24.
|
Change in body fat percentage from baseline, measured using the body composition assessment method specified in the study protocol. Results will be reported as percentage points. |
Baseline, Weeks 12 and 24.
|
|
Change in Fasting Blood Glucose from Baseline
Időkeret: Baseline, Weeks 12 and 24.
|
Change in fasting blood glucose concentration from baseline. Blood samples will be collected after the fasting period specified in the study protocol. Results will be reported in the laboratory's standard concentration unit. |
Baseline, Weeks 12 and 24.
|
|
Change in Glycated Hemoglobin from Baseline
Időkeret: Baseline, Weeks 12 and 24.
|
Change in glycated hemoglobin (HbA1c) from baseline. Results will be reported as a percentage or in mmol/mol, according to the laboratory method. |
Baseline, Weeks 12 and 24.
|
|
Change in Homeostatic Model Assessment of Insulin Resistance from Baseline
Időkeret: Baseline, Weeks 12 and 24.
|
Change in the homeostatic model assessment of insulin resistance (HOMA-IR) from baseline. HOMA-IR will be calculated using fasting glucose and fasting insulin according to the prespecified study method and reported as a dimensionless index. |
Baseline, Weeks 12 and 24.
|
|
Change in Total Cholesterol from Baseline
Időkeret: Baseline, Weeks 12 and 24.
|
Change in serum total cholesterol concentration from baseline. Results will be reported in the laboratory's standard concentration unit. |
Baseline, Weeks 12 and 24.
|
|
Change in Triglyceride Concentration from Baseline
Időkeret: Baseline, Weeks 12 and 24.
|
Change in serum triglyceride concentration from baseline. Results will be reported in the laboratory's standard concentration unit. |
Baseline, Weeks 12 and 24.
|
|
Change in Low-Density Lipoprotein Cholesterol from Baseline
Időkeret: Baseline, Weeks 12 and 24.
|
Change in low-density lipoprotein cholesterol (LDL-C) concentration from baseline. Results will be reported in the laboratory's standard concentration unit. |
Baseline, Weeks 12 and 24.
|
|
Change in High-Density Lipoprotein Cholesterol from Baseline
Időkeret: Baseline, Weeks 12 and 24.
|
Change in high-density lipoprotein cholesterol (HDL-C) concentration from baseline. Results will be reported in the laboratory's standard concentration unit. |
Baseline, Weeks 12 and 24.
|
|
Change in Alanine Aminotransferase from Baseline
Időkeret: Baseline, Weeks 12 and 24.
|
Change in serum alanine aminotransferase (ALT) activity from baseline. Results will be reported in U/L. |
Baseline, Weeks 12 and 24.
|
|
Change in Aspartate Aminotransferase Activity from Baseline
Időkeret: Baseline, Weeks 12 and 24.
|
Change in serum aspartate aminotransferase (AST) activity from baseline, calculated as the AST activity at the follow-up visit minus the AST activity at baseline. Results will be reported in units per liter (U/L). |
Baseline, Weeks 12 and 24.
|
|
Change in Serum Creatinine from Baseline
Időkeret: Baseline, Weeks 12 and 24.
|
Change in serum creatinine concentration from baseline. Results will be reported in the laboratory's standard concentration unit. |
Baseline, Weeks 12 and 24.
|
|
Change in High-Sensitivity C-Reactive Protein from Baseline
Időkeret: Baseline, Weeks 12 and 24.
|
Change in high-sensitivity C-reactive protein (hs-CRP) concentration from baseline. Results will be reported in the laboratory's standard concentration unit. |
Baseline, Weeks 12 and 24.
|
|
Change in Interleukin-1β Concentration from Baseline
Időkeret: Baseline, Weeks 12 and 24.
|
Change in interleukin-1β (IL-1β) concentration from baseline. Results will be reported in the laboratory's standard concentration unit. |
Baseline, Weeks 12 and 24.
|
|
Change in Relative Abundance of Akkermansia from Baseline
Időkeret: Baseline, Weeks 12 and 24.
|
Change in the relative abundance of Akkermansia in fecal samples from baseline, determined using the prespecified gut microbiota analysis method. Results will be reported as relative abundance using the same analytical method at each assessment. |
Baseline, Weeks 12 and 24.
|
|
Changes in Fecal Gut Microbiota Composition Assessed by Microbiome Sequencing
Időkeret: Baseline, Weeks 12 and 24.
|
Changes from baseline in fecal gut microbiota composition assessed by microbiome sequencing. The analysis will characterize the relative abundance of bacterial taxa and identify differences in gut microbial composition between the Akkermansia supplementation group and the placebo group. Relative abundance will be reported for the prespecified microbial taxa using the same sequencing and bioinformatics procedures at each assessment. |
Baseline, Weeks 12 and 24.
|
|
Change in Generalized Anxiety Disorder-7 Total Score from Baseline
Időkeret: Baseline, Weeks 12 and 24.
|
Change in the total score on the Generalized Anxiety Disorder-7 (GAD-7) questionnaire from baseline. The total score ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms. |
Baseline, Weeks 12 and 24.
|
|
Change in Patient Health Questionnaire-9 Total Score from Baseline
Időkeret: Baseline, Weeks 12 and 24.
|
Change in the total score on the Patient Health Questionnaire-9 (PHQ-9) from baseline. The total score ranges from 0 to 27, with higher scores indicating more severe depressive symptoms. |
Baseline, Weeks 12 and 24.
|
|
Change in Pittsburgh Sleep Quality Index Global Score from Baseline
Időkeret: Baseline, Weeks 12 and 24.
|
Change in the global score on the Pittsburgh Sleep Quality Index (PSQI) from baseline. The standard global score ranges from 0 to 21, with higher scores indicating poorer sleep quality. |
Baseline, Weeks 12 and 24.
|
|
Number of Participants with Gastrointestinal Adverse Events
Időkeret: From initiation of the intervention through Week 24.
|
Number and percentage of participants experiencing at least one gastrointestinal adverse event during the study, including diarrhea, constipation, nausea, vomiting, abdominal pain, or abdominal distension. Events will be recorded and classified according to the study's adverse event assessment procedures. |
From initiation of the intervention through Week 24.
|
|
Changes in Fecal Metabolite Profiles Assessed by Metabolomics
Időkeret: Baseline, Weeks 12 and 24.
|
Changes from baseline in fecal metabolite profiles assessed by metabolomics analysis. Prespecified fecal metabolites will be identified and quantified where applicable. Individual metabolites will be reported separately using their respective concentrations or normalized abundance values, according to the validated analytical method. |
Baseline, Weeks 12 and 24.
|
|
Changes in Serum Metabolite Profiles Assessed by Metabolomics
Időkeret: Baseline, Weeks 12 and 24.
|
Changes from baseline in serum metabolite profiles assessed by metabolomics analysis. Prespecified serum metabolites will be identified and quantified where applicable. Individual metabolites will be reported separately using their respective concentrations or normalized abundance values, according to the validated analytical method. |
Baseline, Weeks 12 and 24.
|
|
Change in Fecal 3-Hydroxybutyric Acid Concentration from Baseline
Időkeret: Baseline, Weeks 12 and 24.
|
Change from baseline in the concentration of 3-hydroxybutyric acid (β-hydroxybutyrate, BHB) in fecal samples. BHB will be measured using the prespecified laboratory assay. Results will be reported as concentration per unit of fecal sample using the validated assay's reporting units. |
Baseline, Weeks 12 and 24.
|
|
Change in Serum 3-Hydroxybutyric Acid Concentration from Baseline
Időkeret: Baseline, Weeks 12 and 24.
|
Change from baseline in serum 3-hydroxybutyric acid (β-hydroxybutyrate, BHB) concentration. BHB will be measured using the prespecified laboratory assay. Results will be reported in the applicable concentration unit, such as mmol/L, according to the laboratory method. |
Baseline, Weeks 12 and 24.
|
Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Exploratory Analysis of Baseline Akkermansia Characteristics and Treatment Response
Időkeret: Baseline to Week 24
|
The association between baseline Akkermansia abundance, gut microbiota characteristics, metabolite profiles, and clinical response to Akkermansia supplementation will be explored. |
Baseline to Week 24
|
|
Correlation Analysis Between Gut Microbiota, Metabolites and Clinical Parameters
Időkeret: Baseline, Week 12, and Week 24
|
Exploratory correlation analyses will be performed to evaluate relationships among gut microbiota characteristics, metabolite changes, inflammatory markers, metabolic parameters, and clinical outcomes. |
Baseline, Week 12, and Week 24
|
Együttműködők és nyomozók
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- IIT-2026-284
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
Individual participant data will not be shared with other researchers. The study data will be used for the purposes specified in the protocol and analyzed by the study investigators.
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .