Blood PressureNCT03691194
The Effects of 8 oz Fresh vs. Commercial Orange Juice on Blood Pressure In Normotensive Males Aged 18-59
A study testing fresh orange juice and concentrated orange juice in people with Blood Pressure, run by Loma Linda University at 1 site in United States.
Trial summary
The purpose of this graduate student research study is to determine the effects of drinking eight ounces of fresh vs. commercial orange juice on blood pressure in males with normal blood pressure. Read more about this study
- Who is it for?
- Ages 18 to 59 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- fresh orange juice and concentrated orange juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 1 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 59 years
- Men only
- Healthy volunteers accepted
- Adult
Inclusion Criteria: Healthy 18-59 years old males, willing to keep the same lifestyle, not taking any medications or antioxidant supplements to control blood pressure, and do not drink any types of orange juice within 30 days.
Exclusion Criteria: Diabetic, smoke cigarettes, marijuana or electronic cigarettes, drink alcohol more than one a week, allergic to oranges, and diagnosed as hypotensive or hypertensive.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this graduate student research study is to determine the effects of drinking eight ounces of fresh vs. commercial orange juice on blood pressure in males with normal blood pressure.
Read the detailed description
Visit 1
-
Beginning of the first four weeks:
Upon arrival, subjects will be given a consent form to sign. The student investigators will go over the layoutof the research study such as the procedures, and compliance with them. Then, subjects will be asked if they agree with drinking orange juice daily for two months. If they agree, they will be asked to relax for five minutes, and the student investigators will take their blood pressure reading three times using a blood pressure monitor. The subjects will complete the Perceived Stress Scale (PSS) survey before leaving. The subject will drink orange juice for 28 days.
•
Visits 2, 3, and 4:
Subjects will meet with the student investigators at a convenient location. Subjects will be asked to rest for five minutes. Student investigators will then take their blood pressure reading three times using a blood pressure monitor. The subjects will complete the PSS survey before leaving.
•
Between visit 2 and 3:
There is a washout period of approximately eight weeks. • During the first and second set of the 4
-week intervention phase, subjects will visit student investigators to retrieve orange juice samples every 3 or 4 days.
- Conditions
- Blood Pressure
- Being tested
- fresh orange juice, concentrated orange juice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fresh orange juiceDietary supplement
The fresh oranges will be bought from Sysco. They will be squeezed at the kitchen of School of Allied Health Professional with a juicer. They will either be squeezed the night before or on the same day. The juice will not be treated with additional preservatives or sugar. The brand of the juicer is Kitchen Aid. Eight ounces of fresh orange juice needs approximately two and half oranges. They will be put into 32 oz water bottles that were bought from Sysco, and then store them in the refrigerator. They will be given to the subjects every three or four days.
concentrated orange juiceDietary supplement
The concentrated orange juice will be bought from Sysco then reconstituted. One part of concentrated orange juice needs four parts of water to reconstitute. Then, it will be measured and the reconstituted orange juice will be put into 32 oz water bottles that we bought from Sysco. They will be stored in the refrigerator. The subjects will need to get the reconstituted orange juice every three or four days.
| Study group | Role | What they receive |
|---|---|---|
| fresh orange juice | Experimental | Subject will take 8 ounces of fresh orange every day for 28 days. Receives: Dietary Supplement: fresh orange juice |
| concentrated orange juice | Active comparator | Subject will take 8 ounces of concentrated orange juice every day for 28 days. Receives: Dietary Supplement: concentrated orange juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure
Three readings will be taken each time and average them. If the subject's blood pressure is considered too high or low at any of the visits, they will be dropped from the study and we will suggest to them to see their primary physician.
Measured: change from baseline to 4 weeks
Secondary outcomes (1)
Perceived Stress Scale (PSS)
The PSS was developed by Sheldon Cohen and his colleagues, and was published in 1983. The PSS is a widely used psychological instrument to measures the level of stress. It has been used in many studies related to stress. The survey takes approximately three minutes to complete. The score ranges from 0-40. A score of 0-13 is considered low stress, 14-26 is moderate stress, and 27-40 is high stress.
Measured: change from baseline to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start1 Oct 2018
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by Loma Linda 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cory Gheen, Loma Linda University
- Investigators
- Cory Gheen, MS RD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03691194
- Sponsor's protocol ID
- 5180291
- Status last verified
- Jul 2019
- First submitted
- 24 Sep 2018
- Last updated
- 18 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of 8 oz Fresh vs. Commercial Orange Juice on Blood Pressure In Normotensive Males Aged 18-59
- ClinicalTrials.gov ID
- NCT03691194
- Acronym / sponsor ID
- 5180291
- Conditions
- Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 1 Oct 2018 (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 purpose of this graduate student research study is to determine the effects of drinking eight ounces of fresh vs. commercial orange juice on blood pressure in males with normal blood pressure.
Detailed description
Visit 1
-
Beginning of the first four weeks:
Upon arrival, subjects will be given a consent form to sign. The student investigators will go over the layoutof the research study such as the procedures, and compliance with them. Then, subjects will be asked if they agree with drinking orange juice daily for two months. If they agree, they will be asked to relax for five minutes, and the student investigators will take their blood pressure reading three times using a blood pressure monitor. The subjects will complete the Perceived Stress Scale (PSS) survey before leaving. The subject will drink orange juice for 28 days.
•
Visits 2, 3, and 4:
Subjects will meet with the student investigators at a convenient location. Subjects will be asked to rest for five minutes. Student investigators will then take their blood pressure reading three times using a blood pressure monitor. The subjects will complete the PSS survey before leaving.
•
Between visit 2 and 3:
There is a washout period of approximately eight weeks. • During the first and second set of the 4
-week intervention phase, subjects will visit student investigators to retrieve orange juice samples every 3 or 4 days.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fresh orange juice | Experimental | Dietary Supplement: fresh orange juiceSubject will take 8 ounces of fresh orange every day for 28 days. |
| concentrated orange juice | Active comparator | Dietary Supplement: concentrated orange juiceSubject will take 8 ounces of concentrated orange juice every day for 28 days. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| fresh orange juiceThe fresh oranges will be bought from Sysco. They will be squeezed at the kitchen of School of Allied Health Professional with a juicer. They will either be squeezed the night before or on the same day. The juice will not be treated with additional preservatives or sugar. The brand of the juicer is Kitchen Aid. Eight ounces of fresh orange juice needs approximately two and half oranges. They will be put into 32 oz water bottles that were bought from Sysco, and then store them in the refrigerator. They will be given to the subjects every three or four days. | Dietary supplement | fresh orange juice |
| concentrated orange juiceThe concentrated orange juice will be bought from Sysco then reconstituted. One part of concentrated orange juice needs four parts of water to reconstitute. Then, it will be measured and the reconstituted orange juice will be put into 32 oz water bottles that we bought from Sysco. They will be stored in the refrigerator. The subjects will need to get the reconstituted orange juice every three or four days. | Dietary supplement | concentrated orange juice |
Primary outcome
blood pressure
Time frame: change from baseline to 4 weeks
Three readings will be taken each time and average them. If the subject's blood pressure is considered too high or low at any of the visits, they will be dropped from the study and we will suggest to them to see their primary physician.
1 secondary outcome
Perceived Stress Scale (PSS)
Time frame: change from baseline to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
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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.
Cory Gheen, MS RD principal investigator
Loma Linda 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 fresh orange juice and concentrated orange juice in people with Blood Pressure, run by Loma Linda 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?
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 18 Jul 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
blood pressure (time frame: change from baseline to 4 weeks). 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 18 Jul 2019.