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

14. května 2026 aktualizováno: 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.

Přehled studie

Postavení

Zápis na pozvánku

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

60

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Trojnásobný

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Doplněk stravy: 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.
Ostatní jména:
  • MexMix
Komparátor placeba: 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.
Jiný: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
A ≥1 grade hepatic steatosis improvement with no liver fibrosis worsening
Časové okno: 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
Časové okno: 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%
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
A ≥1 stage liver fibrosis improvement with no hepatic steatosis worsening
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of Guadalajara

Spolupracovníci

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

Vyšetřovatelé

  • Vrchní vyšetřovatel: Juan Armendáriz-Borunda, PhD, FAASLD, University of Guadalajara

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

26. února 2025

Primární dokončení (Odhadovaný)

1. října 2026

Dokončení studie (Odhadovaný)

1. února 2027

Termíny zápisu do studia

První předloženo

30. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

14. května 2026

První zveřejněno (Aktuální)

18. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

18. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

14. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další identifikační čísla studie

  • CI-06624

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu 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.

Časový rámec sdílení IPD

Starting 8 months after publication

Kritéria přístupu pro sdílení 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.

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA
  • ICF
  • CSR

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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