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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01242033
Other study ID # 24774
Secondary ID
Status Completed
Phase N/A
First received November 8, 2010
Last updated December 3, 2010
Start date February 2010
Est. completion date March 2010

Study information

Verified date November 2010
Source University of Toronto
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 30 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
red raspberries
single serving of one, two or four cups red raspberries
bread controls
two slices white bread alone or with 200 mg vitamin C supplement

Locations

Country Name City State
Canada Clinical Nutrition and Risk Factor Modification Centre; St. Michael's Hospital Toronto Ontario

Sponsors (2)

Lead Sponsor Collaborator
University of Toronto St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary change in antioxidant capacity from baseline (-0.25 h) 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 No
Secondary change in lipid peroxidation from baseline (-0.25 h) 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 No
Secondary change in thiols compared to baseline (-0.25 h) 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 No
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