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Effect of Acute Red Raspberry Consumption on Post-prandial Oxidative Stress

This study has been completed.
Sponsor:
Collaborator:
St. Michael's Hospital, Toronto
Information provided by:
University of Toronto
ClinicalTrials.gov Identifier:
NCT01242033
First received: November 8, 2010
Last updated: December 3, 2010
Last verified: November 2010
History of Changes
  Purpose

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.


Condition Intervention
Oxidative Stress
Antioxidants
 Dietary Supplement: red raspberries
Dietary Supplement: bread controls

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: An Acute Intervention Study Investigating the Effect of Red Raspberry Consumption on Post-prandial Oxidative Stress

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • change in antioxidant capacity from baseline (-0.25 h) [ Time Frame: -0.25, 0.25, 0.5, 1, 2, 4 hours post-intake ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • change in lipid peroxidation from baseline (-0.25 h) [ Time Frame: -0.25, 0.25, 0.5, 1, 2, 4 hours post-intake ] [ Designated as safety issue: No ]
    serum thiobarbituric acid reactive substances (TBARS) measured as an indicator of the lipid peroxidation product malondialdehyde (MDA)

  • change in thiols compared to baseline (-0.25 h) [ Time Frame: -025, 0.25, 0.5, 1, 2, 4 hours post-intake ] [ Designated as safety issue: No ]
    plasma thiols quantified by 5,5'-dithiobis-(2-nitrobenzoic acid) (DTNB) assay as an indicator of the level of protection against protein oxidation


Enrollment: 8
Study Start Date: February 2010
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: one cup red raspberries
treatment meal consists of one cup red raspberries
 Dietary Supplement: 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
 Dietary Supplement: 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
 Dietary Supplement: red raspberries
single serving of one, two or four cups red raspberries
Placebo Comparator: bread
treatment meal consists of two slices white bread
 Dietary Supplement: bread controls
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
 Dietary Supplement: bread controls
two slices white bread alone or with 200 mg vitamin C supplement

  Eligibility

Ages Eligible for Study:   20 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01242033

Locations
Canada, Ontario
Clinical Nutrition and Risk Factor Modification Centre; St. Michael's Hospital
Toronto, Ontario, Canada, M5C 2T2
Sponsors and Collaborators
University of Toronto
St. Michael's Hospital, Toronto
Investigators
Principal Investigator: A V Rao, PhD University of Toronto
  More Information

No publications provided

Responsible Party: Dr AV Rao, PhD, Professor Emeritus, Department of Nutritional Sciences, Faculty of Medicine, University of Toronto
ClinicalTrials.gov Identifier: NCT01242033     History of Changes
Other Study ID Numbers: 24774
Study First Received: November 8, 2010
Last Updated: December 3, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Toronto:
red raspberries
post-prandial
oxidative stress
antioxidants
 polyphenols
vitamin C
acute dietary intervention

Additional relevant MeSH terms:
Ascorbic Acid
Vitamins
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 19, 2013