Effect of Ancestry Supplementation in Subjects With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) (Ancestry)
14 мая 2026 г. обновлено: 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.
Обзор исследования
Статус
Запись по приглашению
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Оцененный)
60
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
-
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Guadalajara
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Guadalajara, Guadalajara, Мексика, 44340
- Institute of Molecular Biology in Medicine and Gene Therapy
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Нет
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Тройной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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.
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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.
Другие имена:
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Плацебо Компаратор: 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.
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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.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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A ≥1 grade hepatic steatosis improvement with no liver fibrosis worsening
Временное ограничение: From enrollment to the end of treatment at 12 weeks
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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
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Increase in Alpha Diversity and/or Enrichment of Beneficial Bacterial Genera in the Gut Microbiota
Временное ограничение: From baseline to the end of treatment at 12 weeks
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Gut microbiota composition will be assessed through 16S rRNA gene sequencing of stool samples collected at baseline and after the intervention.
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From baseline to the end of treatment at 12 weeks
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Achieving a clinically significant reduction in total body weight by at least 3%
Временное ограничение: From baseline to the end of treatment at 12 weeks
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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).
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From baseline to the end of treatment at 12 weeks
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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A ≥1 stage liver fibrosis improvement with no hepatic steatosis worsening
Временное ограничение: From baseline to the end of treatment at 12 weeks
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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.
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From baseline to the end of treatment at 12 weeks
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Reduction in the degree of obesity according to Body Mass Index (BMI)
Временное ограничение: From baseline to the end of treatment at 12 weeks
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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.
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From baseline to the end of treatment at 12 weeks
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Reduction in the degree of obesity according to Body Fat Percentage
Временное ограничение: From baseline to the end of treatment at 12 weeks
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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.
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From baseline to the end of treatment at 12 weeks
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Reduction in the degree of obesity according to Visceral Fat Level
Временное ограничение: From baseline to the end of treatment at 12 weeks
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Visceral fat level will be evaluated using the InBody 720 bioelectrical impedance analyzer.
Higher values indicate greater visceral adiposity.
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From baseline to the end of treatment at 12 weeks
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Reduction in the degree of obesity according to Waist Circumference
Временное ограничение: From baseline to the end of treatment at 12 weeks
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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.
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From baseline to the end of treatment at 12 weeks
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Improvement in total cholesterol levels
Временное ограничение: From baseline to the end of treatment at 12 weeks
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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.
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From baseline to the end of treatment at 12 weeks
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Improvement in total triglyceride levels
Временное ограничение: From baseline to the end of treatment at 12 weeks
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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.
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From baseline to the end of treatment at 12 weeks
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Improvement in High-Density Lipoprotein Cholesterol (HDL-C)
Временное ограничение: 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.
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From baseline to the end of treatment at 12 weeks
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Improvement in Low-Density Lipoprotein Cholesterol (LDL-C)
Временное ограничение: From baseline to the end of treatment at 12 weeks
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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.
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From baseline to the end of treatment at 12 weeks
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Improvement in Very Low-Density Lipoprotein Cholesterol (VLDL-C)
Временное ограничение: From baseline to the end of treatment at 12 weeks
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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.
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From baseline to the end of treatment at 12 weeks
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Improvement in Alanine Aminotransferase (ALT)
Временное ограничение: From baseline to the end of treatment at 12 weeks
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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.
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From baseline to the end of treatment at 12 weeks
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Improvement in Aspartate Aminotransferase (AST)
Временное ограничение: From baseline to the end of treatment at 12 weeks
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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.
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From baseline to the end of treatment at 12 weeks
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Improvement in Gamma-glutamyl transferase (GGT)
Временное ограничение: From baseline to the end of treatment at 12 weeks
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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.
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From baseline to the end of treatment at 12 weeks
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Improvement in Fasting Glucose
Временное ограничение: From baseline to the end of treatment at 12 weeks
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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.
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From baseline to the end of treatment at 12 weeks
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Improvement in Fasting Insulin
Временное ограничение: From baseline to the end of treatment at 12 weeks
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Fasting serum insulin concentrations will be measured in µIU/mL by chemiluminescence immunoassay using the Liaison platform (Diasorin).
Higher values indicate greater insulin resistance.
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From baseline to the end of treatment at 12 weeks
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Соавторы
Следователи
- Главный следователь: Juan Armendáriz-Borunda, PhD, FAASLD, University of Guadalajara
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- Rosas-Campos R, Sandoval-Rodriguez AS, Rodriguez-Sanabria JS, Vazquez-Esqueda AO, Alfaro-Martinez CR, Escutia-Gutierrez R, Vega-Magana N, Pena-Rodriguez M, Zepeda-Nuno JS, Andrade-Marcial M, Campos-Uscanga Y, Jave-Suarez LF, Santos A, Cerda-Reyes E, Almeida-Lopez M, Martinez-Lopez E, Herrera LA, Armendariz-Borunda J. A Novel Foodstuff Mixture Improves the Gut-Liver Axis in MASLD Mice and the Gut Microbiota in Overweight/Obese Patients. Antioxidants (Basel). 2024 May 29;13(6):664. doi: 10.3390/antiox13060664.
- Rosas-Campos R, Meza-Rios A, Rodriguez-Sanabria JS, la Rosa-Bibiano R, Corona-Cervantes K, Garcia-Mena J, Santos A, Sandoval-Rodriguez A, Armendariz-Borunda J. Dietary supplementation with Mexican foods, Opuntia ficus indica, Theobroma cacao, and Acheta domesticus: Improving obesogenic and microbiota features in obese mice. Front Nutr. 2022 Dec 2;9:987222. doi: 10.3389/fnut.2022.987222. eCollection 2022.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
26 февраля 2025 г.
Первичное завершение (Оцененный)
1 октября 2026 г.
Завершение исследования (Оцененный)
1 февраля 2027 г.
Даты регистрации исследования
Первый отправленный
30 апреля 2026 г.
Впервые представлено, что соответствует критериям контроля качества
14 мая 2026 г.
Первый опубликованный (Действительный)
18 мая 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
18 мая 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
14 мая 2026 г.
Последняя проверка
1 мая 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- CI-06624
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана IPD
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.
Сроки обмена IPD
Starting 8 months after publication
Критерии совместного доступа к IPD
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.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- МКФ
- КСО
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .