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

14 mai 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Inscription sur invitation

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

60

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Mexique
    • Guadalajara
      • Guadalajara, Guadalajara, Mexique, 44340
        • Institute of Molecular Biology in Medicine and Gene Therapy

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Complément alimentaire: 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.
Autres noms:
  • MexMix
Comparateur placebo: 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.
Autre: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
A ≥1 grade hepatic steatosis improvement with no liver fibrosis worsening
Délai: 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
Délai: 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%
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
A ≥1 stage liver fibrosis improvement with no hepatic steatosis worsening
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Guadalajara

Collaborateurs

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

Les enquêteurs

  • Chercheur principal: Juan Armendáriz-Borunda, PhD, FAASLD, University of Guadalajara

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

26 février 2025

Achèvement primaire (Estimé)

1 octobre 2026

Achèvement de l'étude (Estimé)

1 février 2027

Dates d'inscription aux études

Première soumission

30 avril 2026

Première soumission répondant aux critères de contrôle qualité

14 mai 2026

Première publication (Réel)

18 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

18 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • CI-06624

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime 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.

Délai de partage IPD

Starting 8 months after publication

Critères d'accès au partage 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.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF
  • RSE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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