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

赞助:

合作者:

信息的提供 (责任方):

Cory Gheen，Loma Linda University

追踪信息

首次提交日期 ^ICMJE

September 24, 2018

首次发布日期e ^ICMJE

October 1, 2018

最后更新发布日期

October 1, 2018

预计研究开始日期 ^ICMJE

October 2018

预计主要完成日期

June 2019 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

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.

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

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.

描述性信息

简略标题 ^ICMJE

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

正式标题 ^ICMJE

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

简要概况

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.

详细说明

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.

研究类型 ^ICMJE

Interventional

研究阶段

N/A

研究设计 ^ICMJE

分配: Randomized
干预模型: Crossover Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Other

适用条件 ^ICMJE

干预项目 ^ICMJE

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.
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.

研究工具

Experimental: fresh orange juice
Subject will take 8 ounces of fresh orange every day for 28 days.
Active Comparator: concentrated orange juice
Subject will take 8 ounces of concentrated orange juice every day for 28 days.

招募信息

招募状态 ^ICMJE

Recruiting

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

June 2019

预计主要完成日期

June 2019 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

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.

性别

参与研究的性别:

Male

年龄

最小年龄：18 Years ，最大年龄：59 Years

接受健康的志愿者

没有

可入组国家 ^ICMJE

United States

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

Cory Gheen，Loma Linda University

研究赞助商 ^ICMJE

Loma Linda University

合作者 ^ICMJE

研究员 ^ICMJE

Principal Investigator: Cory Gheen, MS RD Loma Linda University

PRS 账户

Loma Linda University

验证日期

September 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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