The Effects of 8 oz Fresh vs. Commercial Orange Juice on Blood Pressure In Normotensive Males Aged 18-59

Sponsor

Loma Linda University (Other)

Overall Status

Completed

CT.gov ID

NCT03691194

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Blood Pressure	Dietary Supplement: fresh orange juice Dietary Supplement: concentrated orange juice	N/A

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

Study Type:

Interventional

Actual Enrollment :

17 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

The Effects of 8 oz Fresh vs. Commercial Orange Juice on Blood Pressure In Normotensive Males Aged 18-59

Actual Study Start Date :

Oct 1, 2018

Actual Primary Completion Date :

Jun 1, 2019

Actual Study Completion Date :

Jun 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: fresh orange juice Subject will take 8 ounces of fresh orange every day for 28 days.	Dietary Supplement: fresh orange juice 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.	Dietary Supplement: concentrated orange juice 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.

Arm

Intervention/Treatment

Experimental: fresh orange juice

Subject will take 8 ounces of fresh orange every day for 28 days.

Dietary Supplement: fresh orange juice

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.

Dietary Supplement: concentrated orange juice

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.

Outcome Measures

Primary Outcome Measures

blood pressure [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.

Secondary Outcome Measures

Perceived Stress Scale (PSS) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 59 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Loma Linda Universtiy	Loma Linda	California	United States	92350

Sponsors and Collaborators

Loma Linda University

Investigators

Principal Investigator: Cory Gheen, MS RD, Loma Linda University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cory Gheen, Assistant Professor, Loma Linda University

ClinicalTrials.gov Identifier:

NCT03691194

Other Study ID Numbers:

5180291

First Posted:

Oct 1, 2018

Last Update Posted:

Jul 18, 2019

Last Verified:

Jul 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 18, 2019