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

Loma Linda University (LLU)

Status: Completed

Conditions: Blood Pressure

Treatments: Dietary Supplement: fresh orange juice; Dietary Supplement: concentrated orange juice

Study type: Interventional

Funder types: Other

Identifiers

NCT03691194

5180291

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: Male

Ages: 18 to 59 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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 design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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17 participants in 2 patient groups

fresh orange juice

Experimental group

Description:

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

Treatment:

Dietary Supplement: fresh orange juice

concentrated orange juice

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: concentrated orange juice