By InvitationNot Applicable

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

Mexico60 participantsStarted 2025-02-26

Plain-language summary

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.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 int…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 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

Timeframe: From baseline to the end of treatment at 12 weeks

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

Timeframe: From baseline to the end of treatment at 12 weeks

Trial details

NCT IDNCT07592013

SponsorUniversity of Guadalajara

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10

View on ClinicalTrials.gov More MASLD trials

Plain-language summary

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: 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

Timeframe: From baseline to the end of treatment at 12 weeks

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

Timeframe: From baseline to the end of treatment at 12 weeks