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

Enrolling by invitation · Not applicable · Has a placebo group

Conditions studied: MASLD

In brief

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.

Key facts

Study ID

NCT07592013

Run by

University of Guadalajara

People needed

60

Starts

2025-02-26

Expected to finish

2027-02-01

Last updated by the study team

2026-05-18

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Institute of Molecular Biology in Medicine and Gene Therapy — Guadalajara, Guadalajara, Mexico

Full record on ClinicalTrials.gov

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