ObesityNCT02911753
Feasibility and Acceptability of a Beverage Intervention for Hispanic Adults
A study testing Mediterranean Lemonade, Green Tea and Flavored Water in people with Obesity and Hypercholesterolemia, run by University of Arizona at 1 site in United States.
Trial summary
This study aims to 1) assess the feasibility and acceptability of a prescribed beverage intervention in 50 obese Hispanic adults ages 18-64 years over 6 weeks; and 2) assess preliminary effects of the beverage intervention on cholesterol and triglyceride levels as well as other markers of health such as blood… Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Hypercholesterolemia, Hyperglycemia
- What is being tested?
- Mediterranean Lemonade, Green Tea and Flavored Water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Aug 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Self-identify as Hispanic
- 18-64 years of age
- BMI between 30 to 50.0 kg/m²
- Ability to participate in and provide informed consent.
- Speak, read, and write either English and/or Spanish
Who cannot join
- Diagnosis of diabetes mellitus
- History of liver disease
- Current medication for glucose control, cholesterol control; uncontrolled BP
- Current eating disorders such as anorexia nervosa, bulimia, etc. (likely to make adherence to prescribed beverage intake difficult)
- Current alcohol or substance abuse
- Currently treated for psychological issues (i.e. depression, bipolar disorder, etc.), taking psychotropic medications with the previous 12 months, or hospitalized for depression within the previous 5 years
Show all 11Show fewer
- 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
- 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
- Report consumption of ≥ 1 cup of green tea daily and not willing to complete 2 week run-in period
- Report consumption of ≥ 1 cup of citrus fruit daily and not willing to complete 2 week run-in period
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arizona Collaboratory for Metabolic Disease Prevention and Treatment
Tucson, Arizona, 85714
About this study
This study aims to 1) assess the feasibility and acceptability of a prescribed beverage intervention in 50 obese Hispanic adults ages 18-64 years over 6 weeks; and 2) assess preliminary effects of the beverage intervention on cholesterol and triglyceride levels as well as other markers of health such as blood pressure, glucose and markers of inflammation. This project, if successful, will provide early evidence that targeting dietary behavior around beverage intake could be a novel and easily adopted approach to reduce the burden or delay the onset of metabolic abnormalities in obese Hispanic adults. The expected outcome of the proposed project is the identification of feasible and appropriate beverage intervention strategies to improve engagement and adherence to dietary modification approaches for control of metabolic health indicators in this vulnerable ethnic group.
Read the detailed description
In the U.S., Hispanics have the highest rates of overweight and obesity when compared to other racial/ethnic groups placing them at a greater risk for obesity-related disease. Yet, current literature is limited to information on best practices to engage Hispanics in health-promoting lifestyle interventions. Without this information the health consequences associated with obesity, including high blood pressure, elevated blood glucose and high cholesterol, will continue. Evidence exists to support diet-specific behavioral interventions in reducing obesity-related health risks. Among the more adoptable interventions to date are efforts targeting beverage intake. Yet, there are limited data to suggest these approaches are effective for Hispanics despite this being the fastest growing and highest burdened group for obesity-related disease within the U.S. population.
This study aims to 1) assess the feasibility and acceptability of a prescribed beverage intervention in 50 obese Hispanic adults ages 18-64 years over 6 weeks; 2) assess preliminary effects of the beverage intervention on cholesterol and triglyceride levels as well as other markers of health such as blood pressure, glucose and markers of inflammation. This project, if successful, will provide early evidence that targeting dietary behavior around beverage intake could be a novel and easily adopted approach to reduce the burden or delay the onset of metabolic abnormalities in obese Hispanic adults. The expected outcome of the proposed project is the identification of feasible and appropriate beverage intervention strategies to improve engagement and adherence to dietary modification approaches for control of metabolic health indicators in this vulnerable ethnic group.
- Conditions
- Obesity, Hypercholesterolemia, Hyperglycemia, Hypertriglyceridemia
- Being tested
- Mediterranean Lemonade, Green Tea, Flavored Water
- Medical subject headings
- Obesity, Hypercholesterolemia, Hyperglycemia, Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean LemonadeOther
Also called Beverage Consumption Intervention
All participants will be advised to consume all of the beverage assigned (mediterranean lemonade) on a daily basis (rather than save up and consume large amounts on fewer days). The beverages will be prepared in advance by study personnel, refrigerated, and distributed to study participants on a weekly basis. Participants will be provided a daily 32-ounce beverage container for beverage consumption and instructed to clean the container nightly. Participants will also be asked to keep a log of completion of beverage on a daily basis and instructions regarding intake of other beverages will be provided.
Green TeaOther
Also called Beverage Consumption Intervention
All participants will be advised to consume all of the beverage assigned (green tea) on a daily basis (rather than save up and consume large amounts on fewer days). The beverages will be prepared in advance by study personnel, refrigerated, and distributed to study participants on a weekly basis. Participants will be provided a daily 32-ounce beverage container for beverage consumption and instructed to clean the container nightly. Participants will also be asked to keep a log of completion of beverage on a daily basis and instructions regarding intake of other beverages will be provided.
Flavored WaterOther
Also called Beverage Consumption Intervention
All participants will be advised to consume all of the beverage assigned (flavored water) on a daily basis (rather than save up and consume large amounts on fewer days). The beverages will be prepared in advance by study personnel, refrigerated, and distributed to study participants on a weekly basis. Participants will be provided a daily 32-ounce beverage container for beverage consumption and instructed to clean the container nightly. Participants will also be asked to keep a log of completion of beverage on a daily basis and instructions regarding intake of other beverages will be provided.
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean Lemonade Consumption | Experimental | All participants will be asked to consume 32 ounces daily of Mediterranean Lemonade. The beverage will be previously prepared and packaged by study personnel. Participants will receive their beverage supply on a weekly basis for a total of six weeks. Receives: Other: Mediterranean Lemonade |
| Green Tea Consumption | Experimental | All participants will be asked to consume 32 ounces daily of Green Tea. The beverage will be previously prepared and packaged by study personnel. Participants will receive their beverage supply on a weekly basis for a total of six weeks. Receives: Other: Green Tea |
| Flavored Water Consumption | Placebo comparator | All participants will be asked to consume 32 ounces daily of Flavored Water. The beverage will be previously prepared and packaged by study personnel. Participants will receive their beverage supply on a weekly basis for a total of six weeks. Receives: Other: Flavored Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Recruitment: Interest in Participation
The number of Hispanic adults who contact the researchers and express interest in participation.
Measured: Baseline
Study Recruitment: Screened for Eligibility
The number of Hispanic adults screened for eligibility
Measured: Baseline
Study Recruitment: Eligibility
The number of Hispanic adults eligible for study inclusion.
Measured: Baseline
Study Recruitment: Ineligibility
The number of Hispanic adults ineligible for study inclusion.
Measured: Baseline
Enrollment
The number of Hispanic adults enrolled in the study.
Measured: Baseline
Retention
Retention will be measured as the number of participants who remain in the study at 6 weeks.
Measured: Week 6
Treatment Satisfaction
Participants will be asked to rate their overall satisfaction (1- low; 4-high) with the intervention for changing dietary patterns at Week 6 and if they would recommend the program to others.
Measured: Week 6
Secondary outcomes (4)
Change in Total Cholesterol (Baseline and Week 6)
Fasting blood samples (venipuncture) will be collected for the purpose of examining changes in total cholesterol.
Measured: Baseline and Week 6
Change in Fasting Glucose (Baseline and Week 6)
Fasting blood samples (venipuncture) will be collected for the purpose of examining changes in glucose.
Measured: Baseline and Week 6
Change in Hemoglobin A1C (Baseline and Week 6)
Fasting blood samples (venipuncture) were collected for the purpose of examining changes in hemoglobin A1C.
Measured: Baseline and Week 6
Change in Body Weight (Baseline and Week 6)
Body weight was measured on a digital scale to assess change in body weight over the intervention period.
Measured: Baseline and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study startJun 2016
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David O Garcia, PhD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02911753
- Sponsor's protocol ID
- 1606621176
- Status last verified
- Oct 2017
- First submitted
- 19 Sep 2016
- Last updated
- 25 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732.
PubMed 24570244Zheng XX, Xu YL, Li SH, Liu XX, Hui R, Huang XH. Green tea intake lowers fasting serum total and LDL cholesterol in adults: a meta-analysis of 14 randomized controlled trials. Am J Clin Nutr. 2011 Aug;94(2):601-10. doi: 10.3945/ajcn.110.010926. Epub 2011 Jun 29.
PubMed 21715508Hakim IA, Hartz V, Harris RB, Balentine D, Weisgerber UM, Graver E, Whitacre R, Alberts D. Reproducibility and relative validity of a questionnaire to assess intake of black tea polyphenols in epidemiological studies. Cancer Epidemiol Biomarkers Prev. 2001 Jun;10(6):667-78.
PubMed 11401918Garcia DO, Morrill KE, Aceves B, Valdez LA, Rabe BA, Bell ML, Hakim IA, Martinez JA, Thomson CA. Feasibility and acceptability of a beverage intervention for Hispanic adults: results from a pilot randomized controlled trial. Public Health Nutr. 2019 Mar;22(3):542-552. doi: 10.1017/S1368980018003051. Epub 2018 Nov 19.
PubMed 30451147Morrill KE, Aceves B, Valdez LA, Thomson CA, Hakim IA, Bell ML, Martinez JA, Garcia DO. Feasibility and acceptability of a beverage intervention for Hispanic adults: a protocol for a pilot randomized controlled trial. Nutr J. 2018 Feb 9;17(1):16. doi: 10.1186/s12937-018-0329-y.
PubMed 29426328
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of a Beverage Intervention for Hispanic Adults
- ClinicalTrials.gov ID
- NCT02911753
- Acronym / sponsor ID
- 1606621176
- Conditions
- Obesity, Hypercholesterolemia, Hyperglycemia, Hypertriglyceridemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 22 Sep 2016 (estimated)
- Results
- Posted 25 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to 1) assess the feasibility and acceptability of a prescribed beverage intervention in 50 obese Hispanic adults ages 18-64 years over 6 weeks; and 2) assess preliminary effects of the beverage intervention on cholesterol and triglyceride levels as well as other markers of health such as blood pressure, glucose and markers of inflammation. This project, if successful, will provide early evidence that targeting dietary behavior around beverage intake could be a novel and easily adopted approach to reduce the burden or delay the onset of metabolic abnormalities in obese Hispanic adults. The expected outcome of the proposed project is the identification of feasible and appropriate beverage intervention strategies to improve engagement and adherence to dietary modification approaches for control of metabolic health indicators in this vulnerable ethnic group.
Detailed description
In the U.S., Hispanics have the highest rates of overweight and obesity when compared to other racial/ethnic groups placing them at a greater risk for obesity-related disease. Yet, current literature is limited to information on best practices to engage Hispanics in health-promoting lifestyle interventions. Without this information the health consequences associated with obesity, including high blood pressure, elevated blood glucose and high cholesterol, will continue. Evidence exists to support diet-specific behavioral interventions in reducing obesity-related health risks. Among the more adoptable interventions to date are efforts targeting beverage intake. Yet, there are limited data to suggest these approaches are effective for Hispanics despite this being the fastest growing and highest burdened group for obesity-related disease within the U.S. population.
This study aims to 1) assess the feasibility and acceptability of a prescribed beverage intervention in 50 obese Hispanic adults ages 18-64 years over 6 weeks; 2) assess preliminary effects of the beverage intervention on cholesterol and triglyceride levels as well as other markers of health such as blood pressure, glucose and markers of inflammation. This project, if successful, will provide early evidence that targeting dietary behavior around beverage intake could be a novel and easily adopted approach to reduce the burden or delay the onset of metabolic abnormalities in obese Hispanic adults. The expected outcome of the proposed project is the identification of feasible and appropriate beverage intervention strategies to improve engagement and adherence to dietary modification approaches for control of metabolic health indicators in this vulnerable ethnic group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mediterranean Lemonade Consumption | Experimental | Other: Mediterranean LemonadeAll participants will be asked to consume 32 ounces daily of Mediterranean Lemonade. The beverage will be previously prepared and packaged by study personnel. Participants will receive their beverage supply on a weekly basis for a total of six weeks. |
| Green Tea Consumption | Experimental | Other: Green TeaAll participants will be asked to consume 32 ounces daily of Green Tea. The beverage will be previously prepared and packaged by study personnel. Participants will receive their beverage supply on a weekly basis for a total of six weeks. |
| Flavored Water Consumption | Placebo comparator | Other: Flavored WaterAll participants will be asked to consume 32 ounces daily of Flavored Water. The beverage will be previously prepared and packaged by study personnel. Participants will receive their beverage supply on a weekly basis for a total of six weeks. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Self-identify as Hispanic
- 18-64 years of age
- BMI between 30 to 50.0 kg/m²
- Ability to participate in and provide informed consent.
- Speak, read, and write either English and/or Spanish
Key exclusion criteria (11 listed)
- Diagnosis of diabetes mellitus
- History of liver disease
- Current medication for glucose control, cholesterol control; uncontrolled BP
- Current eating disorders such as anorexia nervosa, bulimia, etc. (likely to make adherence to prescribed beverage intake difficult)
- Current alcohol or substance abuse
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 |
|---|---|---|
| Mediterranean LemonadeAlso: Beverage Consumption InterventionAll participants will be advised to consume all of the beverage assigned (mediterranean lemonade) on a daily basis (rather than save up and consume large amounts on fewer days). The beverages will be prepared in advance by study personnel, refrigerated, and distributed to study participants on a weekly basis. Participants will be provided a daily 32-ounce beverage container for beverage consumption and instructed to clean the container nightly. Participants will also be asked to keep a log of completion of beverage on a daily basis and instructions regarding intake of other beverages will be provided. | Other | Mediterranean Lemonade Consumption |
| Green TeaAlso: Beverage Consumption InterventionAll participants will be advised to consume all of the beverage assigned (green tea) on a daily basis (rather than save up and consume large amounts on fewer days). The beverages will be prepared in advance by study personnel, refrigerated, and distributed to study participants on a weekly basis. Participants will be provided a daily 32-ounce beverage container for beverage consumption and instructed to clean the container nightly. Participants will also be asked to keep a log of completion of beverage on a daily basis and instructions regarding intake of other beverages will be provided. | Other | Green Tea Consumption |
| Flavored WaterAlso: Beverage Consumption InterventionAll participants will be advised to consume all of the beverage assigned (flavored water) on a daily basis (rather than save up and consume large amounts on fewer days). The beverages will be prepared in advance by study personnel, refrigerated, and distributed to study participants on a weekly basis. Participants will be provided a daily 32-ounce beverage container for beverage consumption and instructed to clean the container nightly. Participants will also be asked to keep a log of completion of beverage on a daily basis and instructions regarding intake of other beverages will be provided. | Other | Flavored Water Consumption |
Primary outcome
Study Recruitment: Interest in Participation
Time frame: Baseline
The number of Hispanic adults who contact the researchers and express interest in participation.
Study Recruitment: Screened for Eligibility
Time frame: Baseline
The number of Hispanic adults screened for eligibility
Study Recruitment: Eligibility
Time frame: Baseline
The number of Hispanic adults eligible for study inclusion.
Study Recruitment: Ineligibility
Time frame: Baseline
The number of Hispanic adults ineligible for study inclusion.
Enrollment
Time frame: Baseline
The number of Hispanic adults enrolled in the study.
Retention
Time frame: Week 6
Retention will be measured as the number of participants who remain in the study at 6 weeks.
Treatment Satisfaction
Time frame: Week 6
Participants will be asked to rate their overall satisfaction (1- low; 4-high) with the intervention for changing dietary patterns at Week 6 and if they would recommend the program to others.
4 secondary outcomes
Change in Total Cholesterol (Baseline and Week 6)
Time frame: Baseline and Week 6
Change in Fasting Glucose (Baseline and Week 6)
Time frame: Baseline and Week 6
Change in Hemoglobin A1C (Baseline and Week 6)
Time frame: Baseline and Week 6
Change in Body Weight (Baseline and Week 6)
Time frame: Baseline and Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24570244Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732.
- Background: PubMed 21715508Zheng XX, Xu YL, Li SH, Liu XX, Hui R, Huang XH. Green tea intake lowers fasting serum total and LDL cholesterol in adults: a meta-analysis of 14 randomized controlled trials. Am J Clin Nutr. 2011 Aug;94(2):601-10. doi: 10.3945/ajcn.110.010926. Epub 2011 Jun 29.
- Background: PubMed 11401918Hakim IA, Hartz V, Harris RB, Balentine D, Weisgerber UM, Graver E, Whitacre R, Alberts D. Reproducibility and relative validity of a questionnaire to assess intake of black tea polyphenols in epidemiological studies. Cancer Epidemiol Biomarkers Prev. 2001 Jun;10(6):667-78.
- Derived from this study: PubMed 30451147Garcia DO, Morrill KE, Aceves B, Valdez LA, Rabe BA, Bell ML, Hakim IA, Martinez JA, Thomson CA. Feasibility and acceptability of a beverage intervention for Hispanic adults: results from a pilot randomized controlled trial. Public Health Nutr. 2019 Mar;22(3):542-552. doi: 10.1017/S1368980018003051. Epub 2018 Nov 19.
- Derived from this study: PubMed 29426328Morrill KE, Aceves B, Valdez LA, Thomson CA, Hakim IA, Bell ML, Martinez JA, Garcia DO. Feasibility and acceptability of a beverage intervention for Hispanic adults: a protocol for a pilot randomized controlled trial. Nutr J. 2018 Feb 9;17(1):16. doi: 10.1186/s12937-018-0329-y.
- Individual participant dataSharing planned: No
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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. This study is not recruiting at the moment.
David O Garcia, PhD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean Lemonade, Green Tea and Flavored Water in people with Obesity and Hypercholesterolemia, run by University of Arizona at 1 site in United States.
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 5 inclusion and 11 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: finished, as of the sponsor's last update on 25 Oct 2019. 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 United States. 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?
Yes. Results are posted in the registry (first posted 25 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Study Recruitment: Interest in Participation (time frame: Baseline). The study lists 7 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 NCT02911753, which also lists 5 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 25 Oct 2019.