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Completed

NCT Number: NCT01190319

Study: Effects of Strawberries on Blood Pressure

The specific aim of the study is to determine whether a freeze dried powder provided by the California Strawberries Commission, can reduce blood pressure in patients with pre-hypertension. The powder is prepared by the California Strawberry Commission (CSC).

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Key information

Conditions

Pre-Hypertension Cardiovascular Diseases Prehypertension Vascular Diseases

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California Davis (Ragle Hall)

Davis, California, 95616, United States

About this study

Primarily, we would like to find out whether freeze dried strawberry powder lowers blood pressure. In addition we would like to know if the strawberry alters the subject's blood cholesterol and the ability of the subject's blood vessels to relax.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pre-hypertensive men and women (JNC 7 [The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure] criteria) between the ages of 25 and 65 years who have no clinical evidence/history of cardiovascular, respiratory, renal, gastrointestinal or hepatic disease.

Exclusion criteria

  • Subjects who:
  • are taking over the counter anti-oxidant supplements,
  • are taking prescription medications that may interfere with study procedures or endpoints,
  • have unusual dietary habits (eg., pica),
  • are actively losing weight or trying to lose weight,
  • are addicted to drugs or alcohol,
  • present with significant psychiatric or neurological disturbances,
  • have known allergies to strawberry, will be excluded from participating in this study.
  • Patients known to have glaucoma
  • Pregnant and/or lactating females

Treatment and study plan

Strawberry Beverage

Other

Beverage, daily for 8 weeks, 12g freeze-dried strawberry powder

Other names: Strawberry powder made from a mix of California strawberries.

Placebo

Other

Placebo beverage, 8 weeks

Other names: Beverage

Primary outcomes

  1. Change in blood pressure

    Time frame: 8 weeks

Secondary outcomes

  1. Change in low density lipoprotein (LDL) oxidation

    Time frame: 8 weeks

  2. Change in flow mediated dilation (FMD)

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • California Strawberry Commission

Registry information

Official study title

Effect of Strawberry Powder on Blood Pressure in Individuals With Pre-Hypertension

Acronym: CSCBP

Important dates

Study start
2007
Primary completion
2011
Study completion
2015
First posted
Aug 27, 2010
Registry last updated
Jul 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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