- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01242033
Effect of Acute Red Raspberry Consumption on Post-prandial Oxidative Stress
December 3, 2010 updated by: University of Toronto
An Acute Intervention Study Investigating the Effect of Red Raspberry Consumption on Post-prandial Oxidative Stress
Eight healthy adult subjects will be given a meal of one, two or four cups red raspberries, or two slices white bread with or without 200 mg vitamin C, after an overnight fast and consumption of a low polyphenol diet for two days.
Blood samples will be taken at various time points over an eight hour period to measure oxidative stress and antioxidant levels in the blood.
Each subject will attend 5 study visits with one week intervals and be given each meal in a random order.
It is hypothesized that raspberry consumption at higher doses will greater protect against meal-induced oxidative stress compared to bread controls.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Not Applicable
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
20 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- healthy adults
Exclusion Criteria:
- blood pressure greater than 120/80 mm Hg
- body mass index greater than 24.9 kg/m^2
- history of any chronic disease
- currently taking medications
- allergy to fruit
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: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: one cup red raspberries
treatment meal consists of one cup red raspberries
|
single serving of one, two or four cups red raspberries
|
Experimental: two cups red raspberries
treatment meal consists of two cups red raspberries
|
single serving of one, two or four cups red raspberries
|
Experimental: four cups red raspberries
treatment meal consists of four cups red raspberries
|
single serving of one, two or four cups red raspberries
|
Placebo Comparator: bread
treatment meal consists of two slices white bread
|
two slices white bread alone or with 200 mg vitamin C supplement
|
Active Comparator: vitamin C
treatment meal consists of two slices white bread and 200 mg vitamin C in the form of supplemental ascorbic acid
|
two slices white bread alone or with 200 mg vitamin C supplement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in antioxidant capacity from baseline (-0.25 h)
Time Frame: -0.25, 0.25, 0.5, 1, 2, 4 hours post-intake
|
plasma antioxidant capacity measured using the 2,2'-azino-bis(3-ethylbenzthiazoline-6-sulphonic acid) (ABTS) radical cation assay and expressed in Trolox Equivalents (TE)
|
-0.25, 0.25, 0.5, 1, 2, 4 hours post-intake
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in lipid peroxidation from baseline (-0.25 h)
Time Frame: -0.25, 0.25, 0.5, 1, 2, 4 hours post-intake
|
serum thiobarbituric acid reactive substances (TBARS) measured as an indicator of the lipid peroxidation product malondialdehyde (MDA)
|
-0.25, 0.25, 0.5, 1, 2, 4 hours post-intake
|
change in thiols compared to baseline (-0.25 h)
Time Frame: -025, 0.25, 0.5, 1, 2, 4 hours post-intake
|
plasma thiols quantified by 5,5'-dithiobis-(2-nitrobenzoic acid) (DTNB) assay as an indicator of the level of protection against protein oxidation
|
-025, 0.25, 0.5, 1, 2, 4 hours post-intake
|
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, 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
February 1, 2010
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
November 8, 2010
First Submitted That Met QC Criteria
November 12, 2010
First Posted (Estimate)
November 16, 2010
Study Record Updates
Last Update Posted (Estimate)
December 6, 2010
Last Update Submitted That Met QC Criteria
December 3, 2010
Last Verified
November 1, 2010
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 24774
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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