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A Gender and Culturally Specific Approach to Reduce NAFLD in Mexican-American

Men

The safety and scientific validity of this study is the responsibility of the study
sponsor and investigators. Listing a study does not mean it has been evaluated by
the U.S. Federal Government. Know the risks and potential benefits of clinical
studies and talk to your health care provider before participating. Read our
disclaimer for details.

ClinicalTrials.gov Identifier: NCT04186260

Recruitment Status  : Recruiting

First Posted  : December 4, 2019
Last Update Posted  : December 4, 2023

See Contacts and Locations

View this study on the modernized ClinicalTrials.gov

Sponsor:
University of Arizona

Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)

Information provided by (Responsible Party):

University of Arizona

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Study Details Tabular View No Results Posted Disclaimer

How to Read a Study Record

Study Description Go to

Brief Summary:
Using a small Randomized Controlled Trial (RCT) study design, PNPLA3 risk allele carriers (CG/GG genotype)
with NAFLD, will be assigned 2:1 to a tailored NAFLD-specific weight loss intervention compared to a wait-list
control group.

Condition or
Intervention/treatment  Phase 
disease 

NAFLD Behavioral: NAFLD-specific weight loss Not Applicable

intervention

Other: Wait-list control

Detailed Description:
The Mexican-American population accounts for 64.3% of the U.S. Hispanic population and is the fastest
growing Hispanic subgroup. Non-alcoholic fatty liver disease (NAFLD) is a chronic disease associated with
obesity that is highest in the nation for Mexican-American men. NAFLD consists of a spectrum of conditions,
ranging from fatty liver to cirrhosis and liver cancer. Lack of physical activity and sugar-sweetened beverage
consumption are risk factors for NAFLD and are highly evident in the Mexican-American male population.
Additionally, Mexican-American men are at increased risk of NAFLD and liver cancer if they are carriers of a
version of a gene (PNPLA3) found to increase risk and severity of NAFLD. In the absence of prescription
medications, weight loss due to changes in diet and physical activity is recommended for the prevention and
treatment of NAFLD. Changes in lifestyle that result in >5% body weight loss have been shown to improve
levels of liver fat and even reverse the condition. Despite the clear need to develop effective intervention
strategies for Mexican-American men, no studies to date have explored the use of health risk assessment
strategies, including genetic risk, to motivate behavior change to reduce the risk of NAFLD in Mexican-
American men. Consequently, this will be the first weight loss intervention for Mexican-American men to
incorporate genetic predisposition and lifestyle risk factors of NAFLD (e.g., dietary sugar consumption), as a
strategy to improve engagement in weight loss and weight maintenance behaviors.

Study Design Go to

Study Type  : Interventional (Clinical Trial)

Estimated Enrollment  : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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Intervention Model Description:
Masking:
Masking Description:
Primary Purpose:
Official Title:
Estimated Study Start Date  :
Estimated Primary Completion Date  :
Estimated Study Completion Date  :
The pilot study uses a small randomized-controlled trial (RCT)
design that will be conducted in two phases. The first phase
includes recruitment, screening, and baseline assessment
procedures. The second phase will include PNPLA3 risk allele
carriers (CG/GG genotype) with NAFLD, who will be assigned 2:1
to a NAFLD-specific weight loss intervention tailored for Mexican-
American men, including informing them of their lifestyle and
genetic risk, for 12-months compared to a wait-list control group.
Single (Outcomes Assessor)
Assessments will be performed at 0, 6, and 12-months post-
intervention. To minimize the potential for bias, outcome
assessors will be blinded to treatment condition.
Treatment
A Gender and Culturally Specific Approach to Reduce NAFLD in
Mexican-American Men
December 1, 2023
November 30, 2024
December 29, 2024

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Non-alcoholic fatty liver disease

MedlinePlus related topics: Body Weight Weight Control

Genetic and Rare Diseases Information Center resources: Visceral Steatosis

U.S. FDA Resources

Arms and Interventions Go to

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Arm  Intervention/treatment 

Experimental: NAFLD-specific weight loss Behavioral: NAFLD-specific weight loss intervention

intervention This is a 12-month NAFLD-specific weight
Participants will attend 12 weekly 30-45- loss intervention that is explicitly tailored for
minute individual counseling sessions and Mexican-American men. It will include
receive tailored lesson materials focused on recommendations for diet, physical activity,
behavioral strategies for adopting and and will utilize risk for NAFLD as a mechanism
maintaining healthy eating and physical to engage men in lifestyle modification.
activity (PA) behaviors. Participants will self-
monitor their body weight, eating, and PA
behaviors in a weekly journal. Dietary
recommendations will follow nutritional
guidelines for the treatment of NAFLD. To
facilitate the adoption of the dietary
recommendation, participants will be provided
culturally-tailored meal plans and grocery lists
that allow them to make small, practical
dietary changes of ~100 calories. Participants
will be prescribed weekly exercise goals with
the duration increasing from 15-45 minutes, 5
days/week, over the 12-month program. After
the completion of 12 weekly individual
counseling sessions, participants will
complete a 12-week follow-up including bi-
weekly phone calls, followed by a 6-month
follow-up period in which no intervention
contact is made.

Wait-list control Other: Wait-list control

The wait-list control group will receive the
same intervention strategies described for the
NAFLD-specific weight loss intervention after
study comparisons have been made.
Participants in this condition will not receive
treatment for 12-months until study
comparisons have been made. After 12-
months, participants will receive the 12-month
NAFLD-specific weight loss intervention.

Outcome Measures Go to

Primary Outcome Measures  :

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1. Study Recruitment: Interest in Participation at Baseline [ Time Frame: Baseline ]

The number of Mexican-American men who express interest in participation.

2. Study Recruitment: Screened for Eligibility at Baseline [ Time Frame: Baseline ]

The number of Mexican-American men screened for eligibility.

3. Study Recruitment: Eligibility at Baseline [ Time Frame: Baseline ]

The number of Mexican-American men eligible/ineligible for study inclusion and reason for
ineligibility.

4. Study Recruitment: Enrollment at Baseline [ Time Frame: Baseline ]

The number of Mexican-American men enrolled in the study.

5. Retention at 6-months [ Time Frame: 6-months ]

Retention will be measured as the number of participants who remain in the study at 6-months,
divided by the number enrolled.

6. Retention at 12-months [ Time Frame: 12-months ]

Retention will be measured as the number of participants who remain in the study at 12-months,
divided by the number enrolled.

7. Attendance at weekly counseling sessions at 6-months [ Time Frame: 6-months ]

The investigators will use descriptive analyses to examine attendance at weekly counseling
sessions (% sessions attended) at 6-months.

8. Attendance at weekly counseling sessions at 12-months [ Time Frame: 12-months ]

The investigators will use descriptive analyses to examine attendance at weekly counseling
sessions (% sessions attended) at 12-months.

9. Self-monitoring of dietary intake at 6-months [ Time Frame: 6-months ]

The investigators will use descriptive analyses to examine self-monitoring of dietary intake (%
days completed) at 6-months.

10. Self-monitoring of dietary intake at 12-months [ Time Frame: 12-months ]

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The investigators will use descriptive analyses to examine self-monitoring of dietary intake (%
days completed) at 12-months.

11. Self-monitoring of physical activity at 6-months [ Time Frame: 6-months ]

The investigators will use descriptive analyses to examine self-monitoring of physical activity (%
days completed) at 6-months.

12. Self-monitoring of physical activity at 12-months [ Time Frame: 12-months ]

The investigators will use descriptive analyses to examine self-monitoring of physical activity (%
days completed) at 12-months.

13. Self-weighing behaviors at 6-months [ Time Frame: 6-months ]

The investigators will use descriptive analyses to examine self-weighing behaviors (average
days/week) at 6-months.

14. Self-weighing behaviors at 12-months [ Time Frame: 12-months ]

The investigators will use descriptive analyses to examine self-weighing behaviors (average
days/week) at 12-months.

15. Intervention delivery time at 6-months [ Time Frame: 6-months ]

The investigators will use descriptive analyses to examine intervention delivery time (average
minutes/week) at 6-months.

16. Intervention delivery time at 12-months [ Time Frame: 12-months ]

The investigators will use descriptive analyses to examine intervention delivery time (average
minutes/week) at 12-months.

17. Treatment Satisfaction at 6-months: rating [ Time Frame: 6-months ]

Participants will be asked to rate their overall satisfaction (Treatment Satisfaction Survey;
Minimum Score: 1 = very dissatisfied and Maximum Score: 4 = very satisfied) with the tailored
weight loss intervention at 6-months.

18. Treatment Satisfaction at 12-months: rating [ Time Frame: 12-months ]

Participants will be asked to rate their overall satisfaction (Treatment Satisfaction Survey;
Minimum Score: 1 = very dissatisfied and Maximum Score: 4 = very satisfied) with the tailored
weight loss intervention at 12-months.

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Secondary Outcome Measures  :

1. Change in body weight at 6-months [ Time Frame: 6-months ]

Body weight (kg) will be measured on a digital scale to assess change in body weight at 6-
months over the intervention period.

2. Change in body weight at 12-months [ Time Frame: 12-months ]

Body weight (kg) will be measured on a digital scale to assess change in body weight at 12-
months over the intervention period.

3. Change in waist circumference at 6-months [ Time Frame: 6-months ]

Waist circumference (cm) will be assessed using a standardized protocol at 6-months.

4. Change in waist circumference at 12-months [ Time Frame: 12-months ]

Waist circumference (cm) will be assessed using a standardized protocol at 12-months.

5. Change in liver steatosis at 6-months [ Time Frame: 6-months ]

A non-invasive transient elastography (FibroScan®, TE) will be used to measure the amount of
fat (steatosis) present in the liver at 6-months based on controlled attenuation parameters
(CAP).

6. Change in liver steatosis at 12-months [ Time Frame: 12-months ]

A non-invasive transient elastography (FibroScan®, TE) will be used to measure the amount of
fat (steatosis) present in the liver at 12-months based on controlled attenuation parameters
(CAP).

7. Change in liver fibrosis at 6-months [ Time Frame: 6-months ]

A non-invasive transient elastography (FibroScan®, TE) will be used to measure the amount of
liver fibrosis (scaring) present in the liver at 6-months based on kilopascals (kPa).

8. Change in liver fibrosis at 12-months [ Time Frame: 12-months ]

A non-invasive transient elastography (FibroScan®, TE) will be used to measure the amount of
liver fibrosis (scaring) present in the liver at 12-months based on kilopascals (kPa).

9. Change in alanine aminotransferase (ALT) at 6-months [ Time Frame: 6-months ]

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Fasting blood samples will be collected to examine changes in alanine aminotransferase (ALT)
in Units/Liter (U/L) at 6-months.

10. Change in alanine aminotransferase (ALT) at 12-months [ Time Frame: 12-months ]

Fasting blood samples will be collected to examine changes in alanine aminotransferase (ALT)
in Units/Liter (U/L) at 12-months.

11. Change in aspartate aminotransferase (AST) at 6-months [ Time Frame: 6-months ]

Fasting blood samples will be collected to examine changes in aspartate aminotransferase

(AST) in Units/Liter (U/L) at 6-months.

12. Change in aspartate aminotransferase (AST) at 12-months [ Time Frame: 12-months ]

Fasting blood samples will be collected to examine changes in aspartate aminotransferase

(AST) in Units/Liter (U/L) at 12-months.

13. Change in physical activity at 6-months [ Time Frame: 6-months ]

An Actigraph will be used to objectively measure and quantify energy expenditure from
physical activity at 6-months.

14. Change in physical activity at 12-months [ Time Frame: 12-months ]

An Actigraph will be used to objectively measure and quantify energy expenditure from
physical activity at 12-months.

15. Change in dietary intake at 6-months [ Time Frame: 6-months ]

24-hr recalls will be used to assess self reported food intake (kcal/day) at 6-months. This will
be used to estimate calories, dietary fat, protein, and carbohydrates consumed.

16. Change in dietary intake at 12-months [ Time Frame: 12-months ]

24-hr recalls will be used to assess self reported food intake (kcal/day) at 12-months. This will
be used to estimate calories, dietary fat, protein, and carbohydrates consumed.

17. Change in weight loss self-efficacy at 6-months: questionnaire [ Time Frame: 6-months ]

Change in weight loss self-efficacy at 6-months will be measured using a reliable and validated
self reported questionnaire (Weight Efficacy Lifestyle Questionnaire; 10-point Likert scale from
0 (not confident) to 9 (very confident)).

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18. Change in weight loss self-efficacy at 12-months: questionnaire [ Time Frame: 12-months ]

Change in weight loss self-efficacy at 12-months will be measured using a reliable and
validated self reported questionnaire (Weight Efficacy Lifestyle Questionnaire; 10-point Likert
scale from 0 (not confident) to 9 (very confident)).

Eligibility Criteria Go to

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with

your doctor and family members or friends about deciding to join a study. To
learn more about this study, you or your doctor may contact the study research
staff using the contacts provided below. For general information, Learn About
Clinical Studies.

Ages Eligible for Study: 18 Years to 64 Years (Adult)

Sexes Eligible for Study: Male
Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

Self-identify as a Mexican or Mexican-American man

18-64 years of age

BMI between 30 to 50.0 kg/m²

Have a CAP score ≥248 at screening

Be identified as PNPLA3 risk allele carriers (CG/GG genotype) at screening

Be able to provide informed consent
Speak, read, and write either English and/or Spanish.

Exclusion Criteria:

Have active, chronic gastrointestinal disorder (e.g. inflammatory bowel disease, ulcerative colitis,
Chron's disease, celiac disease)
Been previously diagnosed with viral hepatitis, liver disease or liver cancer
Have a history of bariatric surgery

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Report medical condition or treatment for a medical condition that could affect body weight or
ability to engage in structured physical activity that is consistent with the intervention for this study
Have current congestive heart failure, angina, uncontrolled arrhythmia, or other symptoms
indicative of an increased acute risk for a cardiovascular event

Have a resting systolic blood pressure of ≥150 mmHg or resting diastolic blood pressure of ≥100
mmHg
Have an eating disorders that would contraindicate weight loss or physical activity

Report significant alcohol consumption (e.g., drinking ≥ 21 standard drinks/week, binge drinkers, or
those with previous heavy alcohol consumption) identified by the Alcohol Use Disorders
Identification Test
Currently treated for psychological issues (e.g., depression, bipolar disorder, etc.), taking
psychotropic medications with the previous 12 months, or hospitalized for depression within the
previous 5 years

Report exercise on ≥3 days per week for ≥ 20 minutes per day over the past 3 months
Report weight loss of ≥5% or participating in a weight reduction diet program in the past 3 months
Taking any medication or supplement known to affect body composition or history of exposure to
hepatotoxic drugs

Report plans to relocate to a location that limits their access to the study site or having
employment, personal, or travel commitments that prohibit attendance to all of the scheduled
assessments.

Contacts and Locations Go to

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study
research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number):

NCT04186260

Contacts

Contact: Paul Sandoval 520-626-6000 sponsor@email.arizona.edu

Locations

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United States, Arizona

University of Arizona Collaboratory for Metabolic Disease Prevention and Treatment Recruiting

Tucson, Arizona, United States, 85714

Contact: Rosi Vogel 520-626-7279 rosimvogel@email.arizona.edu
Contact: Edgar Villavicencio 520-626-7279 evillavicencio@email.arizona.edu
Principal Investigator: David O. Garcia, PhD

Sponsors and Collaborators

University of Arizona

National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

Principal Investigator: David O Garcia, PhD University of Arizona, Mel & Enid Zuckerman College of P

More Information Go to

Publications:

Kallwitz ER, Daviglus ML, Allison MA, Emory KT, Zhao L, Kuniholm MH, Chen J, Gouskova N, Pirzada
A, Talavera GA, Youngblood ME, Cotler SJ. Prevalence of suspected nonalcoholic fatty liver disease in
Hispanic/Latino individuals differs by heritage. Clin Gastroenterol Hepatol. 2015 Mar;13(3):569-76. doi:
10.1016/j.cgh.2014.08.037. Epub 2014 Sep 15.

Lazo M, Bilal U, Perez-Escamilla R. Epidemiology of NAFLD and Type 2 Diabetes: Health Disparities
Among Persons of Hispanic Origin. Curr Diab Rep. 2015 Dec;15(12):116. doi: 10.1007/s11892-015-
0674-6.

Saab S, Manne V, Nieto J, Schwimmer JB, Chalasani NP. Nonalcoholic Fatty Liver Disease in Latinos.
Clin Gastroenterol Hepatol. 2016 Jan;14(1):5-12; quiz e9-10. doi: 10.1016/j.cgh.2015.05.001. Epub
2015 May 11.

Romeo S, Kozlitina J, Xing C, Pertsemlidis A, Cox D, Pennacchio LA, Boerwinkle E, Cohen JC, Hobbs
HH. Genetic variation in PNPLA3 confers susceptibility to nonalcoholic fatty liver disease. Nat Genet.
2008 Dec;40(12):1461-5. doi: 10.1038/ng.257. Epub 2008 Sep 25.

Severson TJ, Besur S, Bonkovsky HL. Genetic factors that affect nonalcoholic fatty liver disease: A
systematic clinical review. World J Gastroenterol. 2016 Aug 7;22(29):6742-56. doi:
10.3748/wjg.v22.i29.6742.

Tilg H, Moschen A. Weight loss: cornerstone in the treatment of non-alcoholic fatty liver disease.
Minerva Gastroenterol Dietol. 2010 Jun;56(2):159-67.

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4/22/24, 10:46 PM A Gender and Culturally Specific Approach to Reduce NAFLD in Mexican-American Men - Full Text View - ClinicalTrials.gov

Martinez LA, Larrieta E, Kershenobich D, Torre A. The Expression of PNPLA3 Polymorphism could be
the Key for Severe Liver Disease in NAFLD in Hispanic Population. Ann Hepatol. 2017 November-
December,;16(6):909-915. doi: 10.5604/01.3001.0010.5282.

Chalasani N, Younossi Z, Lavine JE, Charlton M, Cusi K, Rinella M, Harrison SA, Brunt EM, Sanyal AJ.
The diagnosis and management of nonalcoholic fatty liver disease: Practice guidance from the
American Association for the Study of Liver Diseases. Hepatology. 2018 Jan;67(1):328-357. doi:
10.1002/hep.29367. Epub 2017 Sep 29. No abstract available.

Jensen MD, Ryan DH, Apovian CM, Ard JD, Comuzzie AG, Donato KA, Hu FB, Hubbard VS, Jakicic
JM, Kushner RF, Loria CM, Millen BE, Nonas CA, Pi-Sunyer FX, Stevens J, Stevens VJ, Wadden TA,
Wolfe BM, Yanovski SZ; American College of Cardiology/American Heart Association Task Force on
Practice Guidelines; Obesity Society. 2013 AHA/ACC/TOS guideline for the management of overweight
and obesity in adults: a report of the American College of Cardiology/American Heart Association Task
Force on Practice Guidelines and The Obesity Society. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):2985-
3023. doi: 10.1016/j.jacc.2013.11.004. Epub 2013 Nov 12. No abstract available. Erratum In: J Am Coll
Cardiol. 2014 Jul 1;63(25 Pt B):3029-3030.

Musso G, Cassader M, Rosina F, Gambino R. Impact of current treatments on liver disease, glucose
metabolism and cardiovascular risk in non-alcoholic fatty liver disease (NAFLD): a systematic review
and meta-analysis of randomised trials. Diabetologia. 2012 Apr;55(4):885-904. doi: 10.1007/s00125-
011-2446-4. Epub 2012 Jan 27.

Responsible Party: University of Arizona

ClinicalTrials.gov Identifier: NCT04186260 History of Changes
Other Study ID Numbers: 1911187047
KMD014761A ( Other Grant/Funding Number: NIMHD )
First Posted: December 4, 2019 Key Record Dates
Last Update Posted: December 4, 2023
Last Verified: October 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD: Yes
Plan Description: The final dataset will be stripped of identifiers prior to release for sharing. Dr.
Garcia will make the data and associated documentation available to users
under a data-sharing agreement that provides for: (1) a commitment to using
the data only for research purposes and not to identify any individual
participant; (2) a commitment to securing the data using appropriate
computer technology; and (3) a commitment to destroying or returning the
data after analyses are completed. The final dataset, including all study

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variables, will be developed for import into standard statistical software

programs including SPSS, SASS and STATA.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: The final dataset will be cleaned and organized during the final study year
and will be available only to the study PI or designees (Co-Investigators,
Collaborators) for 36-months post-study completion. At that time the
dataset then will be made more widely available through data use
agreements with the PI/University of Arizona. Access will require registration
including investigator name, credentials, and academic affiliation.
Access Criteria: Dr. Garcia will make the data and associated documentation available to
users under a data-sharing agreement that provides for: (1) a commitment to
using the data only for research purposes and not to identify any individual
participant; (2) a commitment to securing the data using appropriate
computer technology; and (3) a commitment to destroying or returning the
data after analyses are completed. All study data collection forms will be
made available as pdf files; data collection time-points and dictionary of
data definitions also will be made available.

Studies a U.S. FDA-regulated Drug Product: No

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Arizona:

obesity Mexican-American
overweight men
Mexican weight loss

Additional relevant MeSH terms:

Non-alcoholic Fatty Liver Disease
Fatty Liver
Liver Diseases
Digestive System Diseases

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