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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study 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.

Eligibility

Primary outcome measure(s)

• A ≥1 grade hepatic steatosis improvement with no liver fibrosis worsening — From enrollment to the end of treatment at 12 weeks
  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.
• Increase in Alpha Diversity and/or Enrichment of Beneficial Bacterial Genera in the Gut Microbiota — From baseline to the end of treatment at 12 weeks
  Gut microbiota composition will be assessed through 16S rRNA gene sequencing of stool samples collected at baseline and after the intervention.
• Achieving a clinically significant reduction in total body weight by at least 3% — From baseline to the end of treatment at 12 weeks
  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).

Trial sites (1)

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