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Effect of Ancestry Supplementation in Subjects With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) (Ancestry)

2026年5月14日 更新者：Juan Armendáriz-Borunda, PhD, FAASLD、University of Guadalajara

Effect of Ancestry Supplementation on the Abundance of Beneficial Bacterial Genera in the Gut Microbiota in Subjects With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

The goal of this clinical trial is to evaluate the effect of Ancestry, a supplement made from Mexican-origin foods (nopal, cacao, and cricket) in adults with Metabolic dysfunction-associated steatotic liver disease (MASLD). The main questions it aims to answer are:

  • Does the supplementation with Ancestry improve the hepatic steatosis grade in participants with MASLD?
  • Does the supplementation improve biochemical and anthropometric parameters in participants with MASLD?
  • Does the supplementation enrich the abundance of beneficial bacteria in the gut microbiota of participants?

Researchers will compare the supplement group to a placebo group to see if the supplement is effective.

Participants will:

  • Take the supplement or a placebo every day for 3 months.
  • Receive nutritional guidance from a trained dietitian to control dietary intake.
  • Attend follow-up clinic visits every month for monitoring and checkups.

研究概览

地位

邀请报名

条件

干预/治疗

详细说明

The study will follow a randomized double-blind design. Randomization will be performed in matched pairs according to sex, age (±3 years), diabetes status, body mass index (BMI), and degree of hepatic steatosis. An investigator not involved in participant follow-up will generate a coded randomization list to assign participants to the supplement or placebo group.

Investigators involved in participant assessments and sample processing, as well as study participants, will remain blinded to group allocation throughout the intervention. The supplement and placebo will be provided in identical packaging to maintain blinding.

Hepatic steatosis and fibrosis will be evaluated using the FibroScan Expert 630 device (Echosens, Paris, France), a vibration-controlled transient elastography (VCTE) system, by a physician specialized in hepatology and gastroenterology.

Nutritional consultations and dietary prescriptions will be provided by a trained nutritionist following the clinical recommendations established by the European Association for the Study of the Liver (EASL) and the American Association for the Study of Liver Diseases (AASLD) for MASLD management.

Anthropometric assessment will include height and waist, abdominal, and hip circumferences measured using a Lufkin Rosscraft W606 metallic measuring tape. Body composition analysis will be performed using the InBody 720 bioimpedance analyzer (Biospace), which will provide measurements of body weight, body fat percentage, and visceral fat. All measurements will be interpreted according to standardized guidelines and reference cut-off values.

研究类型

介入性

注册 (估计的)

60

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。

学习地点

  • 墨西哥
    • Guadalajara
      • Guadalajara、Guadalajara、墨西哥、44340
        • Institute of Molecular Biology in Medicine and Gene Therapy

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

  • 成人

接受健康志愿者

不

描述

Inclusion Criteria:

  • Mexican mestizo adults of both sexes between 18 to 60 years old
  • Diagnosis of MASLD according to the criteria established by the American Association for the Study of Liver Diseases
  • Controlled Attenuation Parameter (CAP) score >248 dB/m, liver stiffness <14 kPa according to FibroScan Expert 630 (Echosens, Paris, France)
  • Obesity diagnosed by body fat percentage
  • Bristol stool scale type 3-4
  • Physical inactivity according to the International Physical Activity Questionnaire (IPAQ)
  • Alcohol consumption <20 grams/day for women and <30 grams/day for men
  • Signed informed consent

Exclusion Criteria:

  • Severe gastrointestinal diseases (e.g., chronic constipation, Crohn's disease, celiac disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, etc.), autoimmune diseases, and malignant neoplasms
  • Current or prior 6 weeks consumption of probiotic formulations
  • Current or prior 2 months consumption of antibiotics or antiparasitic drugs before the start of the study
  • Current consumption of dietary supplements (omega-3 fatty acids, thermogenics, protein, teas, etc.)
  • Frequent consumption (greater than or equal to twice a week) of anti-inflammatory drugs, analgesics, or medications that alter normal intestinal function (e.g., laxatives, enemas, antidiarrheal agents, etc.)
  • Pregnant women, women planning pregnancy, or breastfeeding women
  • Weight loss greater than three kilograms in the last month
  • Tobacco consumption
  • Allergy or intolerance to cacao, nopal, or crickets
  • Previous malabsorptive bariatric surgery (gastric bypass, sleeve gastrectomy), restrictive bariatric surgery (adjustable gastric band), or cosmetic surgical procedures (liposuction, lipo-sculpture, abdominoplasty, etc.) in the last 2 years

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：三倍

武器和干预

参与者组/臂
干预/治疗
实验性的：Ancestry Group
Participants in this arm will receive a daily supplement containing a mixture of Mexican-origin foods (nopal, cacao, and cricket) for 3 months. The supplement is named Ancestry. Additionally, participants will receive personalized nutritional guidance from a trained dietitian and will attend monthly follow-up consultations to monitor dietary adherence and overall progress.
膳食补充剂：Ancestry
The active intervention consists of a daily oral supplement in powder form, containing a 30g mixture of dehydrated Mexican-origin foods: nopal (10g), cocoa powder (10g), and cricket (10g). The supplement will be consumed once daily for 3 months. Participants will be instructed to mix the entire 30g powder content with 250 ml of water and consume it immediately.
其他名称：
  • MexMix
安慰剂比较：Placebo Group
Participants in this arm will receive a daily placebo supplement that is identical in appearance to the experimental supplement but without the active ingredients. Additionally, participants will receive personalized nutritional guidance from a trained dietitian and will attend monthly follow-up consultations to monitor dietary adherence and overall progress.
其他：Placebo
The placebo consists of a daily oral supplement in powder form, containing a mixture of calcium caseinate (10g) and maltodextrin (5g). This matched formulation is designed to equalize the caloric value and macronutrient profile of the active intervention. The placebo will be consumed once daily for 3 months. Participants will be instructed to mix the entire powder content with 250 ml of water and consume it immediately.

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
A ≥1 grade hepatic steatosis improvement with no liver fibrosis worsening
大体时间：From enrollment to the end of treatment at 12 weeks

Hepatic steatosis will be assessed using the Controlled Attenuation Parameter (CAP) score in dB/m, where higher values indicate greater hepatic fat accumulation. Steatosis grades will be classified as follows: S0 <248 dB/m, S1 248-268 dB/m, S2 269-280 dB/m, and S3 >280 dB/m. Improvement will be defined as a reduction of at least one steatosis grade according to these CAP cut-off values.

Hepatic fibrosis will be classified according to liver stiffness measurement (LSM) values obtained by Vibration-Controlled Transient Elastography. LSM will be reported in kilopascals (kPa), where higher values indicate greater fibrosis severity. Fibrosis stages will be defined as follows: F0 <6.5 kPa, F1 6.5-7.2 kPa, F2 7.3-9.5 kPa, F3 9.6-14.5 kPa, and F4 >14.5 kPa. Worsening of liver fibrosis will be defined as an increase of at least one fibrosis stage.
From enrollment to the end of treatment at 12 weeks
Increase in Alpha Diversity and/or Enrichment of Beneficial Bacterial Genera in the Gut Microbiota
大体时间：From baseline to the end of treatment at 12 weeks
Gut microbiota composition will be assessed through 16S rRNA gene sequencing of stool samples collected at baseline and after the intervention.
From baseline to the end of treatment at 12 weeks
Achieving a clinically significant reduction in total body weight by at least 3%
大体时间：From baseline to the end of treatment at 12 weeks
Total body weight will be measured using the InBody 720 bioelectrical impedance analyzer (Biospace, South Korea), following standard procedures (fasting state, empty bladder, light clothing).
From baseline to the end of treatment at 12 weeks

次要结果测量

结果测量
措施说明
大体时间
A ≥1 stage liver fibrosis improvement with no hepatic steatosis worsening
大体时间：From baseline to the end of treatment at 12 weeks
Liver fibrosis will be assessed non-invasively via liver stiffness measurement (LSM) in kilopascals (kPa) using Vibration-Controlled Transient Elastography (FibroScan Expert 630, Echosens). Improvement is defined as a reduction of at least 1 fibrosis stage according to established kPa cut-off values. This improvement must occur without concurrent worsening of hepatic steatosis, defined as an increase in grade according to Controlled Attenuation Parameter (CAP) values. Both measurements will be performed simultaneously using the same device.
From baseline to the end of treatment at 12 weeks
Reduction in the degree of obesity according to Body Mass Index (BMI)
大体时间：From baseline to the end of treatment at 12 weeks
Body mass index will be calculated as body weight in kilograms divided by height in meters squared (kg/m²). Higher values indicate greater obesity severity.
From baseline to the end of treatment at 12 weeks
Reduction in the degree of obesity according to Body Fat Percentage
大体时间：From baseline to the end of treatment at 12 weeks
Body Fat Percentage will be assessed using the InBody 720 bioelectrical impedance analyzer. Values range from 0 to 100%, with higher values indicating greater adiposity.
From baseline to the end of treatment at 12 weeks
Reduction in the degree of obesity according to Visceral Fat Level
大体时间：From baseline to the end of treatment at 12 weeks
Visceral fat level will be evaluated using the InBody 720 bioelectrical impedance analyzer. Higher values indicate greater visceral adiposity.
From baseline to the end of treatment at 12 weeks
Reduction in the degree of obesity according to Waist Circumference
大体时间：From baseline to the end of treatment at 12 weeks
Waist circumference will be measured in centimeters using a Lufkin Rosscraft W606 metallic measuring tape at the midpoint between the lowest rib and the iliac crest. Higher values indicate greater central adiposity.
From baseline to the end of treatment at 12 weeks
Improvement in total cholesterol levels
大体时间：From baseline to the end of treatment at 12 weeks
Serum total cholesterol levels will be measured in mg/dL using the Vitros 350 dry chemistry analyzer (Ortho-Clinical Diagnostics). Higher values indicate greater metabolic risk.
From baseline to the end of treatment at 12 weeks
Improvement in total triglyceride levels
大体时间：From baseline to the end of treatment at 12 weeks
Serum triglyceride levels will be measured in mg/dL using the Vitros 350 dry chemistry analyzer (Ortho-Clinical Diagnostics). Higher values indicate greater metabolic risk.
From baseline to the end of treatment at 12 weeks
Improvement in High-Density Lipoprotein Cholesterol (HDL-C)
大体时间：From baseline to the end of treatment at 12 weeks
Serum HDL-C levels will be measured in mg/dL using the Vitros 350 dry chemistry analyzer (Ortho-Clinical Diagnostics). Higher values indicate a more favorable lipid profile.
From baseline to the end of treatment at 12 weeks
Improvement in Low-Density Lipoprotein Cholesterol (LDL-C)
大体时间：From baseline to the end of treatment at 12 weeks
Serum LDL cholesterol levels will be measured in mg/dL using the Vitros 350 dry chemistry analyzer (Ortho-Clinical Diagnostics). Higher values indicate greater metabolic risk.
From baseline to the end of treatment at 12 weeks
Improvement in Very Low-Density Lipoprotein Cholesterol (VLDL-C)
大体时间：From baseline to the end of treatment at 12 weeks
Serum VLDL cholesterol levels will be measured in mg/dL using the Vitros 350 dry chemistry analyzer (Ortho-Clinical Diagnostics). Higher values indicate greater metabolic risk.
From baseline to the end of treatment at 12 weeks
Improvement in Alanine Aminotransferase (ALT)
大体时间：From baseline to the end of treatment at 12 weeks
Serum alanine aminotransferase (ALT) levels will be measured in U/L using the Vitros 350 dry chemistry analyzer (Ortho-Clinical Diagnostics). Higher values indicate greater liver injury.
From baseline to the end of treatment at 12 weeks
Improvement in Aspartate Aminotransferase (AST)
大体时间：From baseline to the end of treatment at 12 weeks
Serum aspartate aminotransferase (AST) levels will be measured in U/L using the Vitros 350 dry chemistry analyzer (Ortho-Clinical Diagnostics). Higher values indicate greater liver injury.
From baseline to the end of treatment at 12 weeks
Improvement in Gamma-glutamyl transferase (GGT)
大体时间：From baseline to the end of treatment at 12 weeks
Serum Gamma-glutamyl transferase (GGT) levels will be measured in U/L using the Vitros 350 dry chemistry analyzer (Ortho-Clinical Diagnostics). Higher values indicate greater liver injury.
From baseline to the end of treatment at 12 weeks
Improvement in Fasting Glucose
大体时间：From baseline to the end of treatment at 12 weeks
Fasting serum glucose levels will be measured in mg/dL using the Vitros 350 dry chemistry analyzer (Ortho-Clinical Diagnostics). Higher values indicate poorer glycemic control.
From baseline to the end of treatment at 12 weeks
Improvement in Fasting Insulin
大体时间：From baseline to the end of treatment at 12 weeks
Fasting serum insulin concentrations will be measured in µIU/mL by chemiluminescence immunoassay using the Liaison platform (Diasorin). Higher values indicate greater insulin resistance.
From baseline to the end of treatment at 12 weeks

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

University of Guadalajara

合作者

Instituto Tecnologico y de Estudios Superiores de Monterey
Instituto de Salud Digestiva y Hepatica S.A de C.V.

调查人员

  • 首席研究员：Juan Armendáriz-Borunda, PhD, FAASLD、University of Guadalajara

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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 (实际的)

2025年2月26日

初级完成 (估计的)

2026年10月1日

研究完成 (估计的)

2027年2月1日

研究注册日期

首次提交

2026年4月30日

首先提交符合 QC 标准的

2026年5月14日

首次发布 (实际的)

2026年5月18日

研究记录更新

最后更新发布 (实际的)

2026年5月18日

上次提交的符合 QC 标准的更新

2026年5月14日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • CI-06624

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

All IPD underlying the results reported in publications derived from this study will be shared with investigators interesteted in this area, including demographic, clinical, biochemical, anthropometric, dietary, and microbiota-related data, after de-identification to protect participant confidentiality. A data dictionary will also be provided to facilitate data interpretation.

IPD 共享时间框架

Starting 8 months after publication

IPD 共享访问标准

De-identified IPD will be made available to qualified researchers upon reasonable request. Access will be granted for scientifically sound research purposes, including secondary analyses, meta-analyses, and validation studies. Requests will be reviewed by the principal investigator and the research team based on the scientific merit of the proposal, the protection of participant confidentiality, and compliance with applicable regulations. Data will be shared through a secure electronic transfer system after approval of a data access agreement.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 企业社会责任

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

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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