NCT00876811

Brief Summary

The purpose of this study is determine whether daily consumption of frozen red raspberries can improve the antioxidant capacity of the blood and reduce the effects of oxidative stress, dose-dependently, in a healthy adult population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2009

Shorter than P25 for phase_1

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 3, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 7, 2009

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

October 29, 2010

Status Verified

October 1, 2010

Enrollment Period

2 months

First QC Date

April 3, 2009

Last Update Submit

October 28, 2010

Conditions

Keywords

raspberryfruitantioxidantspolyphenolsoxidative stressdietary intervention

Outcome Measures

Primary Outcomes (1)

  • serum TBARS

    an indicator of MDA levels, and therefore, lipid peroxidation

    end of week 1, 3, 5 and 9

Secondary Outcomes (2)

  • serum antioxidant capacity (AOC)

    end of week 1, 3, 5 and 9

  • serum thiols

    end of week 1, 3, 5 and 9

Study Arms (3)

one-cup

EXPERIMENTAL
Dietary Supplement: individually quick frozen red raspberries

two-cups

EXPERIMENTAL
Dietary Supplement: individually quick frozen red raspberries

four-cups

EXPERIMENTAL
Dietary Supplement: individually quick frozen red raspberries

Interventions

Consumption of one-cup frozen red raspberries daily for four weeks, followed by a four week period of non-treatment.

one-cup

Eligibility Criteria

Age18 Years - 43 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy adults

You may not qualify if:

  • obese (\>30kg/m2)
  • high blood pressure (140/90mmHg)
  • allergic to raspberries
  • pregnant or lactating
  • history of chronic disease
  • currently taking medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital

Toronto, Ontario, M5C 2T2, Canada

Location

Study Officials

  • A V Rao, PhD

    Department of Nutritional Sciences, University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 3, 2009

First Posted

April 7, 2009

Study Start

March 1, 2009

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

October 29, 2010

Record last verified: 2010-10

Locations