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Enrolling by Invitation

NCT Number: NCT07592013

Effect of Ancestry Supplementation 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.

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Key information

Conditions

MASLD

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Molecular Biology in Medicine and Gene Therapy

Guadalajara, 44340, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ancestry

Dietary Supplement

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.

Other names: MexMix

Placebo

Other

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.

Primary outcomes

  1. A ≥1 grade hepatic steatosis improvement with no liver fibrosis worsening

    Time frame: 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.

  2. Increase in Alpha Diversity and/or Enrichment of Beneficial Bacterial Genera in the Gut Microbiota

    Time frame: 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.

  3. Achieving a clinically significant reduction in total body weight by at least 3%

    Time frame: 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).

Secondary outcomes

  1. A ≥1 stage liver fibrosis improvement with no hepatic steatosis worsening

    Time frame: 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.

  2. Reduction in the degree of obesity according to Body Mass Index (BMI)

    Time frame: 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.

  3. Reduction in the degree of obesity according to Body Fat Percentage

    Time frame: 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.

  4. Reduction in the degree of obesity according to Visceral Fat Level

    Time frame: 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.

  5. Reduction in the degree of obesity according to Waist Circumference

    Time frame: 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.

  6. Improvement in total cholesterol levels

    Time frame: 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.

  7. Improvement in total triglyceride levels

    Time frame: 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.

  8. Improvement in High-Density Lipoprotein Cholesterol (HDL-C)

    Time frame: 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.

  9. Improvement in Low-Density Lipoprotein Cholesterol (LDL-C)

    Time frame: 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.

  10. Improvement in Very Low-Density Lipoprotein Cholesterol (VLDL-C)

    Time frame: 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.

  11. Improvement in Alanine Aminotransferase (ALT)

    Time frame: 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.

  12. Improvement in Aspartate Aminotransferase (AST)

    Time frame: 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.

  13. Improvement in Gamma-glutamyl transferase (GGT)

    Time frame: 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.

  14. Improvement in Fasting Glucose

    Time frame: 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.

  15. Improvement in Fasting Insulin

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Guadalajara

Other

Collaborators

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

Registry information

Official study title

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)

Acronym: Ancestry

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
May 18, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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