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

N/AEnrolling By InvitationNCT07592013

University of Guadalajara60 enrolled

Overview

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.

The study will follow a randomized double-blind design. Randomization will be performed in matched pairs according to sex, age (±3 years), diabetes status, body mass index (BMI), and degree of hepatic steatosis. An investigator not involved in participant follow-up will generate a coded randomization list to assign participants to the supplement or placebo group. Investigators involved in participant assessments and sample processing, as well as study participants, will remain blinded to group allocation throughout the intervention. The supplement and placebo will be provided in identical packaging to maintain blinding. Hepatic steatosis and fibrosis will be evaluated using the FibroScan Expert 630 device (Echosens, Paris, France), a vibration-controlled transient elastography (VCTE) system, by a physician specialized in hepatology and gastroenterology. Nutritional consultations and dietary prescriptions will be provided by a trained nutritionist following the clinical recommendations established by the European Association for the Study of the Liver (EASL) and the American Association for the Study of Liver Diseases (AASLD) for MASLD management. Anthropometric assessment will include height and waist, abdominal, and hip circumferences measured using a Lufkin Rosscraft W606 metallic measuring tape. Body composition analysis will be performed using the InBody 720 bioimpedance analyzer (Biospace), which will provide measurements of body weight, body fat percentage, and visceral fat. All measurements will be interpreted according to standardized guidelines and reference cut-off values.

Study Type

INTERVENTIONAL

Interventions

AncestryDIETARY_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.

PlaceboOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.