MASLDAncestryNCT07592013
Effect of Ancestry Supplementation in Subjects With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
A study testing Ancestry in people with MASLD, run by University of Guadalajara at 1 site in Mexico.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- MASLD
- What is being tested?
- Ancestry
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteMexico
- Study dates
- 26 Feb 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site
Institute of Molecular Biology in Medicine and Gene Therapy
Guadalajara, Guadalajara, 44340
About this study
Official title: Effect of Ancestry Supplementation on the Abundance of Beneficial Bacterial Genera in the Gut Microbiota in Subjects With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
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?
Read more
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.
Read the 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.
- Conditions
- MASLD
- Being tested
- Ancestry, Placebo
- Keywords
- MASLD, Opuntia ficus indica, Theobroma cacao, Acheta domesticus, Gut Microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AncestryDietary supplement
Also called MexMix
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: From baseline to the end of treatment at 12 weeks
Secondary outcomes (15)
A ≥1 stage liver fibrosis improvement with no hepatic steatosis worsening
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.
Measured: From baseline to the end of treatment at 12 weeks
Reduction in the degree of obesity according to Body Mass Index (BMI)
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.
Measured: From baseline to the end of treatment at 12 weeks
Reduction in the degree of obesity according to Body Fat Percentage
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.
Measured: From baseline to the end of treatment at 12 weeks
Reduction in the degree of obesity according to Visceral Fat Level
Visceral fat level will be evaluated using the InBody 720 bioelectrical impedance analyzer. Higher values indicate greater visceral adiposity.
Measured: From baseline to the end of treatment at 12 weeks
Reduction in the degree of obesity according to Waist Circumference
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.
Measured: From baseline to the end of treatment at 12 weeks
Improvement in total cholesterol levels
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.
Measured: From baseline to the end of treatment at 12 weeks
Improvement in total triglyceride levels
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.
Measured: From baseline to the end of treatment at 12 weeks
Improvement in High-Density Lipoprotein Cholesterol (HDL-C)
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.
Measured: From baseline to the end of treatment at 12 weeks
Improvement in Low-Density Lipoprotein Cholesterol (LDL-C)
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.
Measured: From baseline to the end of treatment at 12 weeks
Improvement in Very Low-Density Lipoprotein Cholesterol (VLDL-C)
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.
Measured: From baseline to the end of treatment at 12 weeks
Improvement in Alanine Aminotransferase (ALT)
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.
Measured: From baseline to the end of treatment at 12 weeks
Improvement in Aspartate Aminotransferase (AST)
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.
Measured: From baseline to the end of treatment at 12 weeks
Improvement in Gamma-glutamyl transferase (GGT)
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.
Measured: From baseline to the end of treatment at 12 weeks
Improvement in Fasting Glucose
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.
Measured: From baseline to the end of treatment at 12 weeks
Improvement in Fasting Insulin
Fasting serum insulin concentrations will be measured in µIU/mL by chemiluminescence immunoassay using the Liaison platform (Diasorin). Higher values indicate greater insulin resistance.
Measured: From baseline to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start26 Feb 2025
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MASLDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Digestiva y Hepatica S.A de C.V., Instituto Tecnologico y de Estudios Superiores de Monterey
- Responsible party
- Principal investigator, Juan Armendáriz-Borunda, PhD, FAASLD, University of Guadalajara
- Investigators
- Juan Armendáriz-Borunda, PhD, FAASLD, Principal investigator, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07592013
- Sponsor's protocol ID
- CI-06624
- Acronym
- Ancestry
- Status last verified
- Nov 2026
- First submitted
- 30 Apr 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD underlying the results reported in publications derived from this study will be shared with investigators interesteted in this area, including demographic, clinical, biochemical, anthropometric, dietary, and microbiota-related data, after de-identification to protect participant confidentiality. A data dictionary will also be provided to facilitate data interpretation.
Publications
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.
PubMed 38929103Rosas-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.
PubMed 36532548
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ancestry Supplementation on the Abundance of Beneficial Bacterial Genera in the Gut Microbiota in Subjects With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
- ClinicalTrials.gov ID
- NCT07592013
- Acronym / sponsor ID
- Ancestry / CI-06624
- Conditions
- MASLD
- Keywords
- MASLD, Opuntia ficus indica, Theobroma cacao, Acheta domesticus, Gut Microbiota
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Collaborators
- Instituto de Salud Digestiva y Hepatica S.A de C.V., Instituto Tecnologico y de Estudios Superiores de Monterey
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ancestry Group | Experimental | Dietary Supplement: AncestryParticipants 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. |
| Placebo Group | Placebo comparator | Other: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AncestryAlso: MexMixThe 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. | Dietary supplement | Ancestry Group |
| PlaceboThe 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. | Other | Placebo Group |
Primary outcome
A ≥1 grade hepatic steatosis improvement with no liver fibrosis worsening
Time frame: 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
Time frame: 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%
Time frame: 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).
15 secondary outcomes
A ≥1 stage liver fibrosis improvement with no hepatic steatosis worsening
Time frame: From baseline to the end of treatment at 12 weeks
Reduction in the degree of obesity according to Body Mass Index (BMI)
Time frame: From baseline to the end of treatment at 12 weeks
Reduction in the degree of obesity according to Body Fat Percentage
Time frame: From baseline to the end of treatment at 12 weeks
Reduction in the degree of obesity according to Visceral Fat Level
Time frame: From baseline to the end of treatment at 12 weeks
Reduction in the degree of obesity according to Waist Circumference
Time frame: From baseline to the end of treatment at 12 weeks
Improvement in total cholesterol levels
Time frame: From baseline to the end of treatment at 12 weeks
Improvement in total triglyceride levels
Time frame: From baseline to the end of treatment at 12 weeks
Improvement in High-Density Lipoprotein Cholesterol (HDL-C)
Time frame: From baseline to the end of treatment at 12 weeks
Improvement in Low-Density Lipoprotein Cholesterol (LDL-C)
Time frame: From baseline to the end of treatment at 12 weeks
Improvement in Very Low-Density Lipoprotein Cholesterol (VLDL-C)
Time frame: From baseline to the end of treatment at 12 weeks
Improvement in Alanine Aminotransferase (ALT)
Time frame: From baseline to the end of treatment at 12 weeks
Improvement in Aspartate Aminotransferase (AST)
Time frame: From baseline to the end of treatment at 12 weeks
Improvement in Gamma-glutamyl transferase (GGT)
Time frame: From baseline to the end of treatment at 12 weeks
Improvement in Fasting Glucose
Time frame: From baseline to the end of treatment at 12 weeks
Improvement in Fasting Insulin
Time frame: From baseline to the end of treatment at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Background: PubMed 38929103Rosas-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.
- Background: PubMed 36532548Rosas-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.
- Individual participant dataSharing planned: Yes. All IPD underlying the results reported in publications derived from this study will be shared with investigators interesteted in this area, including demographic, clinical, biochemical, anthropometric, dietary, and microbiota-related data, after de-identification to protect participant confidentiality. A data dictionary will also be provided to facilitate data interpretation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Juan Armendáriz-Borunda, PhD, FAASLD principal investigator
University of Guadalajara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ancestry in people with MASLD, run by University of Guadalajara at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A ≥1 grade hepatic steatosis improvement with no liver fibrosis worsening (time frame: From enrollment to the end of treatment at 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07592013, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026; AzTrials last refreshed its copy on 6 Nov 2026.