MASLD
Conditions
Keywords
MASLD, Opuntia ficus indica, Theobroma cacao, Acheta domesticus, Gut Microbiota
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTAncestry
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.
OTHERPlacebo
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
University of Guadalajara
Instituto de Salud Digestiva y Hepatica S.A de C.V.
Instituto Tecnologico y de Estudios Superiores de Monterey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
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).
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| A ≥1 stage liver fibrosis improvement with no hepatic steatosis worsening | From baseline to the end of treatment at 12 weeks | Liver fibrosis will be assessed non-invasively via liver stiffness measurement (LSM) in kilopascals (kPa) using Vibration-Controlled Transient Elastography (FibroScan Expert 630, Echosens). Improvement is defined as a reduction of at least 1 fibrosis stage according to established kPa cut-off values. This improvement must occur without concurrent worsening of hepatic steatosis, defined as an increase in grade according to Controlled Attenuation Parameter (CAP) values. Both measurements will be performed simultaneously using the same device. |
| Reduction in the degree of obesity according to Body Mass Index (BMI) | From baseline to the end of treatment at 12 weeks | Body mass index will be calculated as body weight in kilograms divided by height in meters squared (kg/m²). Higher values indicate greater obesity severity. |
| Reduction in the degree of obesity according to Body Fat Percentage | From baseline to the end of treatment at 12 weeks | Body Fat Percentage will be assessed using the InBody 720 bioelectrical impedance analyzer. Values range from 0 to 100%, with higher values indicating greater adiposity. |
| Reduction in the degree of obesity according to Visceral Fat Level | From baseline to the end of treatment at 12 weeks | Visceral fat level will be evaluated using the InBody 720 bioelectrical impedance analyzer. Higher values indicate greater visceral adiposity. |
| Reduction in the degree of obesity according to Waist Circumference | From baseline to the end of treatment at 12 weeks | Waist circumference will be measured in centimeters using a Lufkin Rosscraft W606 metallic measuring tape at the midpoint between the lowest rib and the iliac crest. Higher values indicate greater central adiposity. |
| Improvement in total cholesterol levels | From baseline to the end of treatment at 12 weeks | Serum total cholesterol levels will be measured in mg/dL using the Vitros 350 dry chemistry analyzer (Ortho-Clinical Diagnostics). Higher values indicate greater metabolic risk. |
| Improvement in total triglyceride levels | From baseline to the end of treatment at 12 weeks | Serum triglyceride levels will be measured in mg/dL using the Vitros 350 dry chemistry analyzer (Ortho-Clinical Diagnostics). Higher values indicate greater metabolic risk. |
| Improvement in High-Density Lipoprotein Cholesterol (HDL-C) | From baseline to the end of treatment at 12 weeks | Serum HDL-C levels will be measured in mg/dL using the Vitros 350 dry chemistry analyzer (Ortho-Clinical Diagnostics). Higher values indicate a more favorable lipid profile. |
| Improvement in Low-Density Lipoprotein Cholesterol (LDL-C) | From baseline to the end of treatment at 12 weeks | Serum LDL cholesterol levels will be measured in mg/dL using the Vitros 350 dry chemistry analyzer (Ortho-Clinical Diagnostics). Higher values indicate greater metabolic risk. |
| Improvement in Very Low-Density Lipoprotein Cholesterol (VLDL-C) | From baseline to the end of treatment at 12 weeks | Serum VLDL cholesterol levels will be measured in mg/dL using the Vitros 350 dry chemistry analyzer (Ortho-Clinical Diagnostics). Higher values indicate greater metabolic risk. |
| Improvement in Alanine Aminotransferase (ALT) | From baseline to the end of treatment at 12 weeks | Serum alanine aminotransferase (ALT) levels will be measured in U/L using the Vitros 350 dry chemistry analyzer (Ortho-Clinical Diagnostics). Higher values indicate greater liver injury. |
| Improvement in Aspartate Aminotransferase (AST) | From baseline to the end of treatment at 12 weeks | Serum aspartate aminotransferase (AST) levels will be measured in U/L using the Vitros 350 dry chemistry analyzer (Ortho-Clinical Diagnostics). Higher values indicate greater liver injury. |
| Improvement in Gamma-glutamyl transferase (GGT) | From baseline to the end of treatment at 12 weeks | Serum Gamma-glutamyl transferase (GGT) levels will be measured in U/L using the Vitros 350 dry chemistry analyzer (Ortho-Clinical Diagnostics). Higher values indicate greater liver injury. |
| Improvement in Fasting Glucose | From baseline to the end of treatment at 12 weeks | Fasting serum glucose levels will be measured in mg/dL using the Vitros 350 dry chemistry analyzer (Ortho-Clinical Diagnostics). Higher values indicate poorer glycemic control. |
| Improvement in Fasting Insulin | From baseline to the end of treatment at 12 weeks | Fasting serum insulin concentrations will be measured in µIU/mL by chemiluminescence immunoassay using the Liaison platform (Diasorin). Higher values indicate greater insulin resistance. |
Countries
Mexico
Contacts
PRINCIPAL_INVESTIGATORJuan Armendáriz-Borunda, PhD, FAASLD
University of Guadalajara
Outcome results
None listed