Obesity & OverweightNCT07898267
Gut Microbiota-Based Clinical Study of Akkermansia Supplementation for Overweight and Obesity
A study testing Akkermansia Supplement in people with Obesity & Overweight, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity & Overweight
- What is being tested?
- Akkermansia Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2027to 1 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
No. 1, Minde Road, Donghu District, Nanchang University Second Affiliated Hospital
Nanchang, Jiangxi, 330000
Kaige Zhang, PhD, +86 1875401615, zkg1997@126.com
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Obesity & Overweight
- Being tested
- Akkermansia Supplement, Placebo Supplement
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Akkermansia SupplementDietary supplement
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 SupplementDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Akkermansia Supplementation Group | Experimental | 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. Receives: Dietary Supplement: Akkermansia Supplement |
| Placebo Supplementation Group | Placebo comparator | 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. Receives: Dietary Supplement: Placebo Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change in Body Weight from Baseline at 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.
Measured: Baseline and Week 12
Secondary outcomes (25)
Change in Body Mass Index from Baseline
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.
Measured: Baseline, Weeks 4, 8, 12, 18, and 24.
Change in Waist Circumference from Baseline
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.
Measured: Baseline, Weeks 4, 8, 12, 18, and 24.
Change in Body Fat Percentage from Baseline
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.
Measured: Baseline, Weeks 12 and 24.
Change in Fasting Blood Glucose from Baseline
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.
Measured: Baseline, Weeks 12 and 24.
Change in Glycated Hemoglobin from Baseline
Change in glycated hemoglobin (HbA1c) from baseline. Results will be reported as a percentage or in mmol/mol, according to the laboratory method.
Measured: Baseline, Weeks 12 and 24.
Change in Homeostatic Model Assessment of Insulin Resistance from Baseline
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.
Measured: Baseline, Weeks 12 and 24.
Change in Total Cholesterol from Baseline
Change in serum total cholesterol concentration from baseline. Results will be reported in the laboratory's standard concentration unit.
Measured: Baseline, Weeks 12 and 24.
Change in Triglyceride Concentration from Baseline
Change in serum triglyceride concentration from baseline. Results will be reported in the laboratory's standard concentration unit.
Measured: Baseline, Weeks 12 and 24.
Change in Low-Density Lipoprotein Cholesterol from Baseline
Change in low-density lipoprotein cholesterol (LDL-C) concentration from baseline. Results will be reported in the laboratory's standard concentration unit.
Measured: Baseline, Weeks 12 and 24.
Change in High-Density Lipoprotein Cholesterol from Baseline
Change in high-density lipoprotein cholesterol (HDL-C) concentration from baseline. Results will be reported in the laboratory's standard concentration unit.
Measured: Baseline, Weeks 12 and 24.
Change in Alanine Aminotransferase from Baseline
Change in serum alanine aminotransferase (ALT) activity from baseline. Results will be reported in U/L.
Measured: Baseline, Weeks 12 and 24.
Change in Aspartate Aminotransferase Activity from Baseline
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).
Measured: Baseline, Weeks 12 and 24.
Change in Serum Creatinine from Baseline
Change in serum creatinine concentration from baseline. Results will be reported in the laboratory's standard concentration unit.
Measured: Baseline, Weeks 12 and 24.
Change in High-Sensitivity C-Reactive Protein from Baseline
Change in high-sensitivity C-reactive protein (hs-CRP) concentration from baseline. Results will be reported in the laboratory's standard concentration unit.
Measured: Baseline, Weeks 12 and 24.
Change in Interleukin-1β Concentration from Baseline
Change in interleukin-1β (IL-1β) concentration from baseline. Results will be reported in the laboratory's standard concentration unit.
Measured: Baseline, Weeks 12 and 24.
Change in Relative Abundance of Akkermansia from Baseline
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.
Measured: Baseline, Weeks 12 and 24.
Changes in Fecal Gut Microbiota Composition Assessed by Microbiome Sequencing
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.
Measured: Baseline, Weeks 12 and 24.
Change in Generalized Anxiety Disorder-7 Total Score from Baseline
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.
Measured: Baseline, Weeks 12 and 24.
Change in Patient Health Questionnaire-9 Total Score from Baseline
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.
Measured: Baseline, Weeks 12 and 24.
Change in Pittsburgh Sleep Quality Index Global Score from Baseline
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.
Measured: Baseline, Weeks 12 and 24.
Number of Participants with Gastrointestinal Adverse Events
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.
Measured: From initiation of the intervention through Week 24.
Changes in Fecal Metabolite Profiles Assessed by Metabolomics
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.
Measured: Baseline, Weeks 12 and 24.
Changes in Serum Metabolite Profiles Assessed by Metabolomics
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.
Measured: Baseline, Weeks 12 and 24.
Change in Fecal 3-Hydroxybutyric Acid Concentration from Baseline
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.
Measured: Baseline, Weeks 12 and 24.
Change in Serum 3-Hydroxybutyric Acid Concentration from Baseline
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.
Measured: Baseline, Weeks 12 and 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Nanchang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhengyuan Xie, Second Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898267
- Sponsor's protocol ID
- IIT-2026-284
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbiota-Based Clinical Study of Akkermansia Supplementation for Overweight and Obesity
- ClinicalTrials.gov ID
- NCT07898267
- Acronym / sponsor ID
- IIT-2026-284
- Conditions
- Obesity & Overweight
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Akkermansia Supplementation Group | Experimental | Dietary Supplement: Akkermansia SupplementParticipants 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. |
| Placebo Supplementation Group | Placebo comparator | Dietary Supplement: Placebo SupplementParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Healthy Controls:
- Overweight/Obese Participants:
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Akkermansia SupplementAkkermansia 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. | Dietary supplement | Akkermansia Supplementation Group |
| Placebo SupplementThe 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. | Dietary supplement | Placebo Supplementation Group |
Primary outcome
Percentage Change in Body Weight from Baseline at Week 12
Time frame: 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.
25 secondary outcomes
Change in Body Mass Index from Baseline
Time frame: Baseline, Weeks 4, 8, 12, 18, and 24.
Change in Waist Circumference from Baseline
Time frame: Baseline, Weeks 4, 8, 12, 18, and 24.
Change in Body Fat Percentage from Baseline
Time frame: Baseline, Weeks 12 and 24.
Change in Fasting Blood Glucose from Baseline
Time frame: Baseline, Weeks 12 and 24.
Change in Glycated Hemoglobin from Baseline
Time frame: Baseline, Weeks 12 and 24.
Change in Homeostatic Model Assessment of Insulin Resistance from Baseline
Time frame: Baseline, Weeks 12 and 24.
Change in Total Cholesterol from Baseline
Time frame: Baseline, Weeks 12 and 24.
Change in Triglyceride Concentration from Baseline
Time frame: Baseline, Weeks 12 and 24.
Change in Low-Density Lipoprotein Cholesterol from Baseline
Time frame: Baseline, Weeks 12 and 24.
Change in High-Density Lipoprotein Cholesterol from Baseline
Time frame: Baseline, Weeks 12 and 24.
Change in Alanine Aminotransferase from Baseline
Time frame: Baseline, Weeks 12 and 24.
Change in Aspartate Aminotransferase Activity from Baseline
Time frame: Baseline, Weeks 12 and 24.
Change in Serum Creatinine from Baseline
Time frame: Baseline, Weeks 12 and 24.
Change in High-Sensitivity C-Reactive Protein from Baseline
Time frame: Baseline, Weeks 12 and 24.
Change in Interleukin-1β Concentration from Baseline
Time frame: Baseline, Weeks 12 and 24.
Change in Relative Abundance of Akkermansia from Baseline
Time frame: Baseline, Weeks 12 and 24.
Changes in Fecal Gut Microbiota Composition Assessed by Microbiome Sequencing
Time frame: Baseline, Weeks 12 and 24.
Change in Generalized Anxiety Disorder-7 Total Score from Baseline
Time frame: Baseline, Weeks 12 and 24.
Change in Patient Health Questionnaire-9 Total Score from Baseline
Time frame: Baseline, Weeks 12 and 24.
Change in Pittsburgh Sleep Quality Index Global Score from Baseline
Time frame: Baseline, Weeks 12 and 24.
Number of Participants with Gastrointestinal Adverse Events
Time frame: From initiation of the intervention through Week 24.
Changes in Fecal Metabolite Profiles Assessed by Metabolomics
Time frame: Baseline, Weeks 12 and 24.
Changes in Serum Metabolite Profiles Assessed by Metabolomics
Time frame: Baseline, Weeks 12 and 24.
Change in Fecal 3-Hydroxybutyric Acid Concentration from Baseline
Time frame: Baseline, Weeks 12 and 24.
Change in Serum 3-Hydroxybutyric Acid Concentration from Baseline
Time frame: Baseline, Weeks 12 and 24.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Akkermansia Supplement in people with Obesity & Overweight, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhengyuan Xie, PhD (+86 13879182304, xzyxzy1230@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change in Body Weight from Baseline at Week 12 (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.