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

Plain-language summary

This study evaluates the effect of a supplement called Ancestry, compared with placebo, in people with metabolic dysfunction-associated steatotic liver disease (MASLD). Mexican mestizo adults aged 18 to 60 with a diagnosis of MASLD and obesity may take part. This is a study with no assigned phase and it enrolls participants by invitation.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Enrolling by invitation

Sponsor

University of Guadalajara

Intervention

Ancestry, Placebo

Start date

2/26/2025

Estimated completion

2/1/2027

Countries

Mexico

Related genes

Locations

• Guadalajara, Mexico

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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