Metabolic SyndromeNCT02199054
Functional Snack Foods With Safflower Oil and Soy in Postmenopausal Women Having Metabolic Syndrome
A study testing wheat-safflower oil pretzels and soy-safflower oil pretzels in people with Metabolic Syndrome and Overweight, run by Ohio State University at 1 site in United States.
Trial summary
This research study is being done to help researchers develop new dietary options for menopausal women to maintain a healthy weight by developing more nutritious snacks that have health benefits. Read more about this study
- Who is it for?
- Ages 45 to 70 years, women only
- Conditions the study is for
- Metabolic Syndrome, Overweight
- What is being tested?
- wheat-safflower oil pretzels and soy-safflower oil pretzels
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to 10 Apr 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 45 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women 45 to 70 years of age
- Stated to be postmenopausal and has a cessation of menstruation for greater than 12 months
- Have a body mass index ≥25 kg/m2
- Must meet three of the five following criteria12
- Have a waist circumference greater than 35 inches
- Fasting serum triglycerides of greater than 150 mg/dL
Show all 11Show fewer
- Fasting high density lipoprotein (HDL) less than 40 mg/dL
- Fasting blood glucose greater than 100 mg/dL
- Systolic blood pressure greater than 130 mm Hg or diastolic blood pressure greater than 85 mm Hg
- Agree to consume a standardized vitamin/mineral supplement and avoid other nutrition and alternative supplements for the duration of the study
- Agree to follow a legume free diet and to document any accidental consumption of restricted foods each day of the study
Who cannot join
- Have an active metabolic or digestive illness including malabsorptive disorders, renal insufficiency, hepatic insufficiency, or had recent (within the year) gastrointestinal surgery.
- Have a history or have active hormone related diseases of the pituitary, thyroid or pancreas that currently require supplemental hormonal administration thyroid hormones, adrenocorticotropic hormone (ACTH), growth hormone or other endocrine disorders requiring hormone or insulin administration
- Have an active or a recent history of any condition that causes altered immunity such as chronic inflammatory disease, autoimmune disorders, cancer, anemia, and blood dyscrasias
- Are on cholesterol lowering medications which include but not limited to statins, niacin (vitamin B3), bile-acid resins, fibric acid derivatives, or cholesterol absorption inhibitors.
- Have a known allergy or food intolerance to ingredients in study products (wheat, soy, or safflower oil)
- Are strict vegans (no consumption of animal, fish or egg products)
Show all 10Show fewer
- Are heavy alcohol consumers (defined as an average consumption of greater than 14 drinks/week)
- Have a history of cancer or currently undergoing treatment for cancer
- Have been on an antibiotic regime lasting for more than one week in the last 6 months
- Are currently on another study for weight loss or trying to actively lose weight or recently (last 3 months) started medications for weight loss.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center Clinical Research Center
Columbus, Ohio, 43210
About this study
Official title: Evaluation of Functional Snack Foods Containing Safflower Oil and Soy on Endpoints of Energy Metabolism in Postmenopausal Women With Metabolic Syndrome
This research study is being done to help researchers develop new dietary options for menopausal women to maintain a healthy weight by developing more nutritious snacks that have health benefits. From this study, the researchers hope to gain understanding on how menopausal women with metabolic syndrome digest and absorb foods with safflower oil on its own and when combined with soy. The research team hypothesize that the two different types of pretzels may be processed by your body differently and that components in the pretzel snacks may be helpful for preventing diseases like obesity and cancer. Safflower oil and soybeans contain many natural chemicals that may benefit human health. However, this relationship is not well understood. This study will look at the impact of the pretzel snacks on your blood fat and glucose levels as well as a group of chemicals found in soy called "isoflavones". Isoflavones are natural chemicals found commonly in soybeans or foods made from them.
Participants will be screened to determine if they qualify in meeting the study requirements. Participants cannot have a known allergy to dairy, soy, safflower oil, or wheat protein. Also, participants will be asked to stop eating legumes (beans, peas, soy protein, sprouts and peanuts) and to document the oils they eat for the entire 14 weeks of this study. The study will require five visits to the Ohio State University Clinical Research Center (CRC) which part of the Ohio State University's Center for Clinical and Translational Sciences. Once the investigators have determined that you qualify for this study and you decide to participate, you will be consuming three different pretzels each for one month, starting with a control pretzel. After the control pretzel treatment period, you will be randomly assigned (like the "flip of a coin") to start with one of the two pretzel groups (wheat or soy pretzel with safflower oil) for your first treatment period and then switch to the other safflower oil pretzel at your second treatment period.
Read the detailed description
The overarching goal is to develop new dietary strategies to help postmenopausal women maintain a healthy weight by improving the availability of nutritious snacks that contain added health benefits and will be used to assess the impact of a functional snack on snacking behavior. The primary objective is to evaluate safflower oil delivered in a wheat pretzel compared to a wheat pretzel enhanced with soy will have a greater affect on blood triglyceride and glucose levels thereby affecting satiety and snacking behavior. The investigators hypothesize that a functional snack food such as a soft pretzel containing safflower oil either with or without soy compared to the control pretzel (wheat pretzel with no safflower oil) will reduce postprandial blood triglycerides and glucose.
This proposed multidisciplinary study is a randomized cross-over trial involving 20 overweight (BMI > 25 kg/m2) postmenopausal women with metabolic syndrome will participate in a dietary intervention study for a total of 14 weeks (two weeks of washout and three 4 week interventions). The study will require five visits to the Ohio State University Clinical Research Center (CRC), part of the Center for Clinical and Translational Sciences, Figure 5. Women will visit the CRC to be screened (Day-14) and their eligibility will be determined using a health and lifestyle questionnaire and results from a 12 hour fasting lipid panel (total cholesterol, LDL, HDL, triglycerides). Those meeting the National Cholesterol Education Program criteria for metabolic syndrome and having no other excluding conditions will be enrolled. Prior to their oral triglyceride tolerance tests (OTTT), women will be instructed to abstain from a. alcohol consumption for 72 hour, b. consume ≥150g of carbohydrates for 24 hours, c. abstain from vigorous exercise for 24 hours, d. collect urine for 24 hours, e. fast for 12 hours prior to all their clinic visits. When women arrive at the CRC for their clinic visits, weight and vital signs will be collected and a venous catheter placed for timed blood collections. Blood will be collected for serum triglycerides and glucose prior to (-5 minutes) and at 30, 60, 90, 120, 150, 180, 240, 300, and 360 minutes after consumption of the test meal. At their run-in visit (Day 0), subjects will consume a control pretzel with a flavored oil dip containing a standardized quantity of triglycerides (50 g long chain fatty acids). At the first treatment period (Day 28) visit, women will be randomized to one of the two intervention groups (wheat or soy pretzel with safflower oil) and then crossover to the other safflower oil pretzel at their second treatment period visit (Day 56). The two intervention pretzel meals will be accompanied with the same oil dip provided before. At the end of each OTTT visit women will be instructed to continue eating the test pretzels (12 pretzel bites/day) for the next 28 days as a snack. Subjects will be instructed to complete questions pertaining to their satiety during their 7 hour stay. Women will return for their last visit on Day 84 to submit all completed study materials (survey, dietary recall, and daily intake journal), completed 24 hour urine collection, and blood collection.
- Conditions
- Metabolic Syndrome, Overweight
- Being tested
- wheat-safflower oil pretzels, soy-safflower oil pretzels, control wheat pretzels
- Keywords
- Snack Foods, Safflower Oil, Soy, Postmenopausal women, Metabolic Syndrome
- Medical subject headings
- Metabolic Syndrome, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wheat-safflower oil pretzelsOther
Each serving (6 pieces) of the wheat-safflower oil pretzel contains 6 grams of safflower oil. Ingredients in the pretzel are high gluten wheat flour, safflower oil, sugar, yeast, salt, and ascorbic acid.
soy-safflower oil pretzelsOther
Each serving (6 pieces) of the soy-safflower oil pretzel contains 6 grams of safflower oil. Ingredients in the pretzel are high gluten wheat flour, soy flour, soymilk, safflower oil, sugar, yeast, salt, and ascorbic acid.
control wheat pretzelsOther
Each serving (6 pieces) of the control wheat pretzel contains 6 grams of vegetable shortening. Ingredients in the pretzel are high gluten wheat flour, vegetable shortening, sugar, yeast, salt, and ascorbic acid.
| Study group | Role | What they receive |
|---|---|---|
| Run-in Intervention | Placebo comparator | Control wheat pretzel bites (12 pieces total) will be consumed with a flavored oil dip containing a standardized quantity of triglycerides (50 g long chain fatty acids) at the start of a 7 hour clinic visit as well as 6 pieces of control wheat pretzels will be eaten twice a day (total of 12 pieces/day) for 28 days. During these 28 days, participants will monitor their oil consumption and maintain a legume-free diet. Receives: Other: control wheat pretzels |
| Wheat-Safflower Oil Arm | Active comparator | Wheat-safflower oil pretzel bites (12 pieces total) will be consumed with a flavored oil dip containing a standardized quantity of triglycerides (50 g long chain fatty acids) at the start of a 7 hour clinic visit as well as 6 pieces of wheat-safflower oil pretzels will be eaten twice a day (total of 12 pieces/day) for 28 days. During these 28 days, participants will monitor their oil consumption and maintain a legume-free diet. Receives: Other: wheat-safflower oil pretzels |
| Soy-Safflower Oil Arm | Active comparator | Soy-safflower oil pretzel bites (12 pieces total) will be consumed with a flavored oil dip containing a standardized quantity of triglycerides (50 g long chain fatty acids) at the start of a 7 hour clinic visit as well as 6 pieces of soy-safflower oil pretzels will be eaten twice a day (total of 12 pieces/day) for 28 days. During these 28 days, participants will monitor their oil consumption and maintain a legume-free diet. Receives: Other: soy-safflower oil pretzels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants having Serious and Non-serious Adverse Events.
Standardized qualitative and quantitative toxicity criteria (NIH) will be employed to evaluate safety and toxicity of daily safflower oil consumption.
Measured: Up to 3 months
Number of Participants with 80% Adherence to Safflower Oil Pretzels
The daily consumption of safflower oil pretzels with and without soy will be assessed with a daily dietary intake journal as well as with measures of isoflavone and linoleic acid metabolites in urine and blood, respectively.
Measured: Up to 3 months
Secondary outcomes (2)
Number of Participants with Improved Satiety Visual Analogue Scale (VAS) with Safflower Oil Pretzel Snacks Compared to Control Pretzels.
The impact of safflower oil pretzels with and without soy on snacking behavior and satiety will be measured by comparing visual analogue scale surveys, food frequency questionnaires, and total energy intake extracted from 24 hour dietary recalls.
Measured: Up to 3 months
Area Under the Concentration-Time Curve for Serum Triglyceride and Glucose
Postprandial triglycerides and glucose following consumption of a single meal consisting of safflower oil pretzels with or without soy will be compared to a control pretzel having neither safflower oil nor soy.
Measured: Before test meal, 30, 60, 90, 120, 150, 180, 240, 300, and 360 minutes after the test meal on Days 0, 28, and 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2014 (estimated)
- Study startJul 2014
- Primary completion10 Apr 2027 (estimated)
- Study completion10 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yael Vodovotz, Ohio State University
- Investigators
- Yael Vodovotz, Ph.D., Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02199054
- Sponsor's protocol ID
- 2014H0045
- Other IDs
- 2013
- Status last verified
- Apr 2026
- First submitted
- 19 Jul 2014
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Functional Snack Foods Containing Safflower Oil and Soy on Endpoints of Energy Metabolism in Postmenopausal Women With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT02199054
- Acronym / sponsor ID
- 2014H0045
- Conditions
- Metabolic Syndrome, Overweight
- Keywords
- Snack Foods, Safflower Oil, Soy, Postmenopausal women, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Jul 2014 (actual)
- Primary completion
- 10 Apr 2027 (estimated)
- Study completion
- 10 Apr 2027 (estimated)
- First posted
- 24 Jul 2014 (estimated)
- 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.
This research study is being done to help researchers develop new dietary options for menopausal women to maintain a healthy weight by developing more nutritious snacks that have health benefits. From this study, the researchers hope to gain understanding on how menopausal women with metabolic syndrome digest and absorb foods with safflower oil on its own and when combined with soy. The research team hypothesize that the two different types of pretzels may be processed by your body differently and that components in the pretzel snacks may be helpful for preventing diseases like obesity and cancer. Safflower oil and soybeans contain many natural chemicals that may benefit human health. However, this relationship is not well understood. This study will look at the impact of the pretzel snacks on your blood fat and glucose levels as well as a group of chemicals found in soy called "isoflavones". Isoflavones are natural chemicals found commonly in soybeans or foods made from them.
Participants will be screened to determine if they qualify in meeting the study requirements. Participants cannot have a known allergy to dairy, soy, safflower oil, or wheat protein. Also, participants will be asked to stop eating legumes (beans, peas, soy protein, sprouts and peanuts) and to document the oils they eat for the entire 14 weeks of this study. The study will require five visits to the Ohio State University Clinical Research Center (CRC) which part of the Ohio State University's Center for Clinical and Translational Sciences. Once the investigators have determined that you qualify for this study and you decide to participate, you will be consuming three different pretzels each for one month, starting with a control pretzel. After the control pretzel treatment period, you will be randomly assigned (like the "flip of a coin") to start with one of the two pretzel groups (wheat or soy pretzel with safflower oil) for your first treatment period and then switch to the other safflower oil pretzel at your second treatment period.
Detailed description
The overarching goal is to develop new dietary strategies to help postmenopausal women maintain a healthy weight by improving the availability of nutritious snacks that contain added health benefits and will be used to assess the impact of a functional snack on snacking behavior. The primary objective is to evaluate safflower oil delivered in a wheat pretzel compared to a wheat pretzel enhanced with soy will have a greater affect on blood triglyceride and glucose levels thereby affecting satiety and snacking behavior. The investigators hypothesize that a functional snack food such as a soft pretzel containing safflower oil either with or without soy compared to the control pretzel (wheat pretzel with no safflower oil) will reduce postprandial blood triglycerides and glucose.
This proposed multidisciplinary study is a randomized cross-over trial involving 20 overweight (BMI > 25 kg/m2) postmenopausal women with metabolic syndrome will participate in a dietary intervention study for a total of 14 weeks (two weeks of washout and three 4 week interventions). The study will require five visits to the Ohio State University Clinical Research Center (CRC), part of the Center for Clinical and Translational Sciences, Figure 5. Women will visit the CRC to be screened (Day-14) and their eligibility will be determined using a health and lifestyle questionnaire and results from a 12 hour fasting lipid panel (total cholesterol, LDL, HDL, triglycerides). Those meeting the National Cholesterol Education Program criteria for metabolic syndrome and having no other excluding conditions will be enrolled. Prior to their oral triglyceride tolerance tests (OTTT), women will be instructed to abstain from a. alcohol consumption for 72 hour, b. consume ≥150g of carbohydrates for 24 hours, c. abstain from vigorous exercise for 24 hours, d. collect urine for 24 hours, e. fast for 12 hours prior to all their clinic visits. When women arrive at the CRC for their clinic visits, weight and vital signs will be collected and a venous catheter placed for timed blood collections. Blood will be collected for serum triglycerides and glucose prior to (-5 minutes) and at 30, 60, 90, 120, 150, 180, 240, 300, and 360 minutes after consumption of the test meal. At their run-in visit (Day 0), subjects will consume a control pretzel with a flavored oil dip containing a standardized quantity of triglycerides (50 g long chain fatty acids). At the first treatment period (Day 28) visit, women will be randomized to one of the two intervention groups (wheat or soy pretzel with safflower oil) and then crossover to the other safflower oil pretzel at their second treatment period visit (Day 56). The two intervention pretzel meals will be accompanied with the same oil dip provided before. At the end of each OTTT visit women will be instructed to continue eating the test pretzels (12 pretzel bites/day) for the next 28 days as a snack. Subjects will be instructed to complete questions pertaining to their satiety during their 7 hour stay. Women will return for their last visit on Day 84 to submit all completed study materials (survey, dietary recall, and daily intake journal), completed 24 hour urine collection, and blood collection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Run-in Intervention | Placebo comparator | Other: control wheat pretzelsControl wheat pretzel bites (12 pieces total) will be consumed with a flavored oil dip containing a standardized quantity of triglycerides (50 g long chain fatty acids) at the start of a 7 hour clinic visit as well as 6 pieces of control wheat pretzels will be eaten twice a day (total of 12 pieces/day) for 28 days. During these 28 days, participants will monitor their oil consumption and maintain a legume-free diet. |
| Wheat-Safflower Oil Arm | Active comparator | Other: wheat-safflower oil pretzelsWheat-safflower oil pretzel bites (12 pieces total) will be consumed with a flavored oil dip containing a standardized quantity of triglycerides (50 g long chain fatty acids) at the start of a 7 hour clinic visit as well as 6 pieces of wheat-safflower oil pretzels will be eaten twice a day (total of 12 pieces/day) for 28 days. During these 28 days, participants will monitor their oil consumption and maintain a legume-free diet. |
| Soy-Safflower Oil Arm | Active comparator | Other: soy-safflower oil pretzelsSoy-safflower oil pretzel bites (12 pieces total) will be consumed with a flavored oil dip containing a standardized quantity of triglycerides (50 g long chain fatty acids) at the start of a 7 hour clinic visit as well as 6 pieces of soy-safflower oil pretzels will be eaten twice a day (total of 12 pieces/day) for 28 days. During these 28 days, participants will monitor their oil consumption and maintain a legume-free diet. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Postmenopausal women 45 to 70 years of age
- Stated to be postmenopausal and has a cessation of menstruation for greater than 12 months
- Have a body mass index ≥25 kg/m2
- Must meet three of the five following criteria12
- Agree to consume a standardized vitamin/mineral supplement and avoid other nutrition and alternative supplements for the duration of the study
Key exclusion criteria (10 listed)
- Have an active metabolic or digestive illness including malabsorptive disorders, renal insufficiency, hepatic insufficiency, or had recent (within the year) gastrointestinal surgery.
- Have a history or have active hormone related diseases of the pituitary, thyroid or pancreas that currently require supplemental hormonal administration thyroid hormones, adrenocorticotropic hormone (ACTH), growth hormone or other endocrine disorders requiring hormone or insulin administration
- Have an active or a recent history of any condition that causes altered immunity such as chronic inflammatory disease, autoimmune disorders, cancer, anemia, and blood dyscrasias
- Are on cholesterol lowering medications which include but not limited to statins, niacin (vitamin B3), bile-acid resins, fibric acid derivatives, or cholesterol absorption inhibitors.
- Have a known allergy or food intolerance to ingredients in study products (wheat, soy, or safflower oil)
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 |
|---|---|---|
| wheat-safflower oil pretzelsEach serving (6 pieces) of the wheat-safflower oil pretzel contains 6 grams of safflower oil. Ingredients in the pretzel are high gluten wheat flour, safflower oil, sugar, yeast, salt, and ascorbic acid. | Other | Wheat-Safflower Oil Arm |
| soy-safflower oil pretzelsEach serving (6 pieces) of the soy-safflower oil pretzel contains 6 grams of safflower oil. Ingredients in the pretzel are high gluten wheat flour, soy flour, soymilk, safflower oil, sugar, yeast, salt, and ascorbic acid. | Other | Soy-Safflower Oil Arm |
| control wheat pretzelsEach serving (6 pieces) of the control wheat pretzel contains 6 grams of vegetable shortening. Ingredients in the pretzel are high gluten wheat flour, vegetable shortening, sugar, yeast, salt, and ascorbic acid. | Other | Run-in Intervention |
Primary outcome
Number of Participants having Serious and Non-serious Adverse Events.
Time frame: Up to 3 months
Standardized qualitative and quantitative toxicity criteria (NIH) will be employed to evaluate safety and toxicity of daily safflower oil consumption.
Number of Participants with 80% Adherence to Safflower Oil Pretzels
Time frame: Up to 3 months
The daily consumption of safflower oil pretzels with and without soy will be assessed with a daily dietary intake journal as well as with measures of isoflavone and linoleic acid metabolites in urine and blood, respectively.
2 secondary outcomes
Number of Participants with Improved Satiety Visual Analogue Scale (VAS) with Safflower Oil Pretzel Snacks Compared to Control Pretzels.
Time frame: Up to 3 months
Area Under the Concentration-Time Curve for Serum Triglyceride and Glucose
Time frame: Before test meal, 30, 60, 90, 120, 150, 180, 240, 300, and 360 minutes after the test meal on Days 0, 28, and 56
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 20 Apr 2026.
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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. This study is not recruiting at the moment.
Yael Vodovotz, Ph.D. principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wheat-safflower oil pretzels and soy-safflower oil pretzels in people with Metabolic Syndrome and Overweight, run by Ohio State University 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 11 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: under way, not looking for participants, as of the sponsor's last update on 20 Apr 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 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?
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?
Number of Participants having Serious and Non-serious Adverse Events. (time frame: Up to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2026.