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Gut Microbiota-Based Clinical Study of Akkermansia Supplementation for Overweight and Obesity

2026年11月3日 更新者：Zhengyuan Xie、Second Affiliated Hospital of Nanchang University

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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

150

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Jiangxi
      • Nanchang、Jiangxi、中国、330000
        • No. 1, Minde Road, Donghu District, Nanchang University Second Affiliated Hospital
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 60年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

This study includes healthy controls and participants with overweight or obesity. Eligibility criteria are as follows:

Inclusion Criteria:

  1. Healthy Controls:

    1. Aged 18-60 years, any sex;
    2. BMI between 18.5 and 24.9 kg/m²;
    3. Body weight change <5% within the past 3 months;
    4. No obesity-related metabolic diseases, including type 2 diabetes mellitus, impaired glucose tolerance, hypertension, dyslipidemia, or nonalcoholic fatty liver disease;
    5. No use of antibiotics, probiotics, prebiotics, synbiotics, postbiotics, weight-loss medications, glucocorticoids, or immunosuppressive agents within the past 3 months;
    6. No gastrointestinal diseases that may significantly affect gut microbiota;
    7. No severe diseases involving the cardiovascular, cerebrovascular, hepatic, renal, hematological, or endocrine systems, and no history of malignant tumors;
    8. Not pregnant, lactating, or planning pregnancy;
    9. Willing to participate voluntarily, provide fecal and blood samples and clinical data, and sign written informed consent.

  2. Overweight/Obese Participants:

    1. Aged 18-60 years, any sex;
    2. BMI between 25.0 and 34.9 kg/m²;
    3. Body weight change <5% within the past 3 months;
    4. Willing to maintain relatively stable dietary habits, physical activity, and daily routines during the study period;
    5. Able to complete the 12-week intervention and 24-week follow-up;
    6. Willing to provide fecal and blood samples and clinical data;
    7. Willing to participate voluntarily and sign written informed consent.

Exclusion Criteria:

  1. Use of antibiotics, probiotics, prebiotics, synbiotics, postbiotics, or other microbiota-modulating products within the past 3 months;
  2. Use of weight-loss medications within the past 3 months, including GLP-1 receptor agonists, orlistat, or metformin used for weight management;
  3. Participation in commercial weight-loss programs or intensive lifestyle interventions within the past 3 months;
  4. Previous bariatric surgery or planned bariatric surgery during the study period;
  5. Type 1 diabetes mellitus or type 2 diabetes mellitus requiring insulin therapy;
  6. Uncontrolled hypertension, severe cardiovascular or cerebrovascular diseases, severe hepatic or renal dysfunction, malignant tumors, immunodeficiency, or active infections;
  7. 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;
  8. Pregnancy, lactation, or planning to become pregnant during the study;
  9. Known allergy to any component of the study products;
  10. Participation in other clinical studies that may affect study outcomes;
  11. For participants entering the second-phase randomized controlled trial, high baseline Akkermansia abundance (Akkermansia abundance ≥1.5%) identified by gut microbiota testing;
  12. Any condition considered unsuitable for participation by the investigator.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
膳食补充剂：Akkermansia 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.
安慰剂比较：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.
膳食补充剂：Placebo 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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Percentage Change in Body Weight from Baseline at Week 12
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Change in Body Mass Index from Baseline
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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.

其他结果措施

结果测量
措施说明
大体时间
Exploratory Analysis of Baseline Akkermansia Characteristics and Treatment Response
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Second Affiliated Hospital of Nanchang University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2027年1月1日

初级完成 (估计的)

2028年9月1日

研究完成 (估计的)

2029年9月1日

研究注册日期

首次提交

2026年10月14日

首先提交符合 QC 标准的

2026年10月20日

首次发布 (实际的)

2026年10月27日

研究记录更新

最后更新发布 (实际的)

2026年11月5日

上次提交的符合 QC 标准的更新

2026年11月3日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • IIT-2026-284

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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