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

NCT07592013 | Enrolling By Invitation

• 1 other identifier: CI-06624
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

MASLD; Opuntia ficus indica; Theobroma cacao; Acheta domesticus; Gut Microbiota

Outcome Measures

Primary Outcomes (3)

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

  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.

  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

  Gut microbiota composition will be assessed through 16S rRNA gene sequencing of stool samples collected at baseline and after the intervention.

  From baseline to the end of treatment at 12 weeks

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

  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).

  From baseline to the end of treatment at 12 weeks

Secondary Outcomes (15)

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

  From baseline to the end of treatment at 12 weeks

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

  From baseline to the end of treatment at 12 weeks

• Reduction in the degree of obesity according to Body Fat Percentage

  From baseline to the end of treatment at 12 weeks

• Reduction in the degree of obesity according to Visceral Fat Level

  From baseline to the end of treatment at 12 weeks

• Reduction in the degree of obesity according to Waist Circumference

  From baseline to the end of treatment at 12 weeks

Study Arms (2)

Ancestry Group

EXPERIMENTAL

Participants in this arm will receive a daily supplement containing a mixture of Mexican-origin foods (nopal, cacao, and cricket) for 3 months. The supplement is named Ancestry. Additionally, participants will receive personalized nutritional guidance from a trained dietitian and will attend monthly follow-up consultations to monitor dietary adherence and overall progress.

Dietary Supplement: Ancestry

Placebo Group

PLACEBO COMPARATOR

Participants in this arm will receive a daily placebo supplement that is identical in appearance to the experimental supplement but without the active ingredients. Additionally, participants will receive personalized nutritional guidance from a trained dietitian and will attend monthly follow-up consultations to monitor dietary adherence and overall progress.

Other: Placebo

Interventions

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.

Also known as: MexMix

Ancestry Group

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.

Placebo Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• University of Guadalajara: lead
• Instituto de Salud Digestiva y Hepatica S.A de C.V.: collaborator
• Instituto Tecnologico y de Estudios Superiores de Monterey: collaborator

Study Sites (1)

Institute of Molecular Biology in Medicine and Gene Therapy

Guadalajara, Guadalajara, 44340, Mexico

Location

Related Publications (2)

• Rosas-Campos R, Sandoval-Rodriguez AS, Rodriguez-Sanabria JS, Vazquez-Esqueda AO, Alfaro-Martinez CR, Escutia-Gutierrez R, Vega-Magana N, Pena-Rodriguez M, Zepeda-Nuno JS, Andrade-Marcial M, Campos-Uscanga Y, Jave-Suarez LF, Santos A, Cerda-Reyes E, Almeida-Lopez M, Martinez-Lopez E, Herrera LA, Armendariz-Borunda J. A Novel Foodstuff Mixture Improves the Gut-Liver Axis in MASLD Mice and the Gut Microbiota in Overweight/Obese Patients. Antioxidants (Basel). 2024 May 29;13(6):664. doi: 10.3390/antiox13060664.

  PMID: 38929103 BACKGROUND

• Rosas-Campos R, Meza-Rios A, Rodriguez-Sanabria JS, la Rosa-Bibiano R, Corona-Cervantes K, Garcia-Mena J, Santos A, Sandoval-Rodriguez A, Armendariz-Borunda J. Dietary supplementation with Mexican foods, Opuntia ficus indica, Theobroma cacao, and Acheta domesticus: Improving obesogenic and microbiota features in obese mice. Front Nutr. 2022 Dec 2;9:987222. doi: 10.3389/fnut.2022.987222. eCollection 2022.

  PMID: 36532548 BACKGROUND

Study Officials

• Juan Armendáriz-Borunda, PhD, FAASLD

  University of Guadalajara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The researchers administering the supplements, conducting interviews, and following up with patients will remain "blind" to the study throughout the intervention period. Similarly, the personnel responsible for assessing the primary outcome (hepatic steatosis degree).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Institute for Molecular Biology in Medicine, CUCS, University of Guadalajara

Model Details: Randomized, double-blind, placebo-controlled clinical trial. Participants will be randomly assigned in a 1.4:1 ratio to receive either the experimental dietary supplement or a matching placebo for 3 months. Randomization will be performed using stratified randomization based on the variables of sex, age, diabetes status, and BMI to ensure balanced groups.

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 18, 2026
• Study Start: February 26, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Starting 8 months after publication
• Access Criteria: De-identified IPD will be made available to qualified researchers upon reasonable request. Access will be granted for scientifically sound research purposes, including secondary analyses, meta-analyses, and validation studies. Requests will be reviewed by the principal investigator and the research team based on the scientific merit of the proposal, the protection of participant confidentiality, and compliance with applicable regulations. Data will be shared through a secure electronic transfer system after approval of a data access agreement.

Locations

ME (1)