Effect of Ancestry Supplementation in Subjects With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
NCT07592013 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2026-05-18
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.
Conditions
- MASLD
Interventions
- DIETARY_SUPPLEMENT
-
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.
- OTHER
-
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.
Sponsors & Collaborators
-
Instituto de Salud Digestiva y Hepatica S.A de C.V.
collaborator OTHER -
Instituto Tecnologico y de Estudios Superiores de Monterey
collaborator OTHER -
University of Guadalajara
lead OTHER
Principal Investigators
-
Juan Armendáriz-Borunda, PhD, FAASLD · University of Guadalajara
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-26
- Primary Completion
- 2026-10-31
- Completion
- 2027-02-28
Countries
- Mexico
Study Locations
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