NCT01190319

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2009

Completed
10 months until next milestone

First Posted

Study publicly available on registry

August 27, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

July 13, 2017

Status Verified

July 1, 2017

Enrollment Period

4.1 years

First QC Date

October 20, 2009

Last Update Submit

July 11, 2017

Conditions

Pre-hypertension

Keywords

blood pressurestrawberryfruit phenolicsLDL oxidationFlow mediated dilation (FMD)

Outcome Measures

Primary Outcomes (1)

  • Change in blood pressure

    8 weeks

Secondary Outcomes (2)

  • Change in low density lipoprotein (LDL) oxidation

    8 weeks

  • Change in flow mediated dilation (FMD)

    8 weeks

Study Arms (2)

Placebo Beverage

PLACEBO COMPARATOR

The placebo beverage is matched in energy, macronutrient composition and sensory properties to the active beverage, but is devoid of strawberry polyphenols.

Other: Placebo

Strawberry Beverage

EXPERIMENTAL

The strawberry beverage is matched in energy, macronutrient composition and sensory properties to the placebo beverage, but contains strawberry polyphenols.

Other: Strawberry Beverage

Interventions

Strawberry BeverageOTHER

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

Also known as: Strawberry powder made from a mix of California strawberries.
Strawberry Beverage
PlaceboOTHER

Placebo beverage, 8 weeks

Also known as: Beverage
Placebo Beverage

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Davis (Ragle Hall)

Davis, California, 95616, United States

Location

MeSH Terms

Conditions

Prehypertension

Interventions

Beverages

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Chulani T Kappagoda, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

  • Britt Burton-Freeman, Ph.D

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2009

First Posted

August 27, 2010

Study Start

September 1, 2007

Primary Completion

October 1, 2011

Study Completion

December 1, 2015

Last Updated

July 13, 2017

Record last verified: 2017-07

Locations

US(1)