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

NCT03691194 | Completed

• 1 other identifier: 5180291
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

• 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.

  change from baseline to 4 weeks

Secondary Outcomes (1)

• Perceived Stress Scale (PSS)

  change from baseline to 4 weeks

Study Arms (2)

fresh orange juice

EXPERIMENTAL

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

Dietary Supplement: fresh orange juice

concentrated orange juice

ACTIVE COMPARATOR

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

Dietary Supplement: concentrated orange juice

Interventions

fresh orange juice DIETARY_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.

fresh orange juice

concentrated orange juice DIETARY_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.

concentrated orange juice

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda Universtiy

Loma Linda, California, 92350, United States

Location

Study Officials

• Cory Gheen, MS RD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 24, 2018
• First Posted: October 1, 2018
• Study Start: October 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: July 18, 2019

Record last verified: 2019-07

Locations

US (1)