- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00876811
Effect of Red Raspberry Consumption on Fasting Oxidative Stress Biomarkers
October 28, 2010 updated by: University of Toronto
Raspberries and Human Health: A Short-term Intervention Trial Investigating the Effect of Daily Red Raspberry Consumption on Fasting Oxidative Stress Biomarkers
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5C 2T2
- Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 43 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: one-cup
|
Consumption of one-cup frozen red raspberries daily for four weeks, followed by a four week period of non-treatment.
Consumption of one-cup frozen red raspberries for two weeks, then consumption of two-cups frozen red raspberries for an additional two weeks, followed by four weeks of non-treatment.
Consumption of one-cup frozen red raspberries for two weeks, then consumption of four-cups frozen red raspberries for an addition two weeks, followed by four weeks of non-treatment.
|
Experimental: two-cups
|
Consumption of one-cup frozen red raspberries daily for four weeks, followed by a four week period of non-treatment.
Consumption of one-cup frozen red raspberries for two weeks, then consumption of two-cups frozen red raspberries for an additional two weeks, followed by four weeks of non-treatment.
Consumption of one-cup frozen red raspberries for two weeks, then consumption of four-cups frozen red raspberries for an addition two weeks, followed by four weeks of non-treatment.
|
Experimental: four-cups
|
Consumption of one-cup frozen red raspberries daily for four weeks, followed by a four week period of non-treatment.
Consumption of one-cup frozen red raspberries for two weeks, then consumption of two-cups frozen red raspberries for an additional two weeks, followed by four weeks of non-treatment.
Consumption of one-cup frozen red raspberries for two weeks, then consumption of four-cups frozen red raspberries for an addition two weeks, followed by four weeks of non-treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
serum TBARS
Time Frame: end of week 1, 3, 5 and 9
|
an indicator of MDA levels, and therefore, lipid peroxidation
|
end of week 1, 3, 5 and 9
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
serum antioxidant capacity (AOC)
Time Frame: end of week 1, 3, 5 and 9
|
measured using the TEAC-ABTS radical cation assay
|
end of week 1, 3, 5 and 9
|
serum thiols
Time Frame: end of week 1, 3, 5 and 9
|
measured using the DTNB assay, as an indicator of antioxidant levels in protein fraction
|
end of week 1, 3, 5 and 9
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: A V Rao, PhD, Department of Nutritional Sciences, University of Toronto
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Primary Completion (Actual)
May 1, 2009
Study Completion (Actual)
May 1, 2009
Study Registration Dates
First Submitted
April 3, 2009
First Submitted That Met QC Criteria
April 3, 2009
First Posted (Estimate)
April 7, 2009
Study Record Updates
Last Update Posted (Estimate)
October 29, 2010
Last Update Submitted That Met QC Criteria
October 28, 2010
Last Verified
October 1, 2010
More Information
Terms related to this study
Other Study ID Numbers
- 22069
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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