- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03691194
The Effects of 8 oz Fresh vs. Commercial Orange Juice on Blood Pressure In Normotensive Males Aged 18-59
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Loma Linda, California, United States, 92350
- Loma Linda Universtiy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: fresh orange juice
Subject will take 8 ounces of fresh orange every day for 28 days.
|
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.
|
ACTIVE_COMPARATOR: concentrated orange juice
Subject will take 8 ounces of concentrated orange juice every day for 28 days.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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change from baseline to 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived Stress Scale (PSS)
Time Frame: change from baseline to 4 weeks
|
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.
|
change from baseline to 4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Cory Gheen, MS RD, Loma Linda University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 5180291
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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