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Clinical Trials/NCT00876811
NCT00876811CompletedPhase 1

Raspberries and Human Health: A Short-term Intervention Trial Investigating the Effect of Daily Red Raspberry Consumption on Fasting Oxidative Stress Biomarkers

University of Toronto1 site in 1 country24 target enrollmentStarted: March 1, 2009Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
24
Locations
1
Primary Endpoint
serum TBARS

Study Overview

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.

Detailed Description

Red raspberries are an excellent source of numerous polyphenolic antioxidants. The bioactivity of these compounds have been implicated in many biological pathways and may function to reduce the risk of numerous chronic diseases. We are conducting an intervention study with frozen red raspberries on a healthy adult population in order to determine if raspberry polyphenols are bioavailable and bioactive in vivo. Twenty-four subjects (12 male and 12 female) will be recruited to participate and consume one-cup frozen red raspberries daily for two weeks, they then will randomly be assigned to consume either one, two or four cups of raspberries for another two weeks, this will be followed by four weeks of non-treatment. Blood samples and 12-hour urine collections will be taken in order to measure the concentration of raspberry polyphenols in response to treatment dose. Dose-dependent treatment effects on blood biomarkers for antioxidant capacity, oxidative stress, inflammation and other chronic disease risk factors will also be measured.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 43 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •healthy adults

Exclusion Criteria

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

Arms & Interventions

four-cups

Experimental

Intervention: individually quick frozen red raspberries (Dietary Supplement)

one-cup

Experimental

Intervention: individually quick frozen red raspberries (Dietary Supplement)

two-cups

Experimental

Intervention: individually quick frozen red raspberries (Dietary Supplement)

Outcomes

Primary Outcomes

serum TBARS

Time Frame: end of week 1, 3, 5 and 9

an indicator of MDA levels, and therefore, lipid peroxidation

Secondary Outcomes

  • serum antioxidant capacity (AOC)(end of week 1, 3, 5 and 9)
  • serum thiols(end of week 1, 3, 5 and 9)

Investigators

Sponsor Class
Other

Study Sites (1)

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