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

Not Applicable

Completed

• Conditions: Blood Pressure
• Interventions: Dietary Supplement: fresh orange juice; Dietary Supplement: concentrated orange juice

• Registration Number: NCT03691194
• Lead Sponsor: Loma Linda University

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.

Detailed Description

Visit 1

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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.

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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.

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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 Timeline

• Study First Submitted: 2018-09-24
• Study First Submitted QC: 2018-09-26
• Study Start: 2018-10-01
• Study First Posted: 2018-10-01
• Primary Completion: 2019-06-01
• Study Completion: 2019-06-01
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-16
• Last Update Posted: 2019-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 17

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
fresh orange juice	fresh orange juice	Subject will take 8 ounces of fresh orange every day for 28 days.
concentrated orange juice	concentrated orange juice	Subject will take 8 ounces of concentrated orange juice every day for 28 days.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Loma Linda Universtiy; 🇺🇸 Loma Linda, California, United States