Effect of Red Raspberry Consumption on Fasting Oxidative Stress Biomarkers

This study has been completed.
Sponsor:
Collaborator:
St. Michael's Hospital, Toronto
Information provided by:
University of Toronto
ClinicalTrials.gov Identifier:
NCT00876811
First received: April 3, 2009
Last updated: October 28, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention Phase
Oxidative Stress
Dietary Supplement: individually quick frozen red raspberries
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Raspberries and Human Health: A Short-term Intervention Trial Investigating the Effect of Daily Red Raspberry Consumption on Fasting Oxidative Stress Biomarkers

Resource links provided by NLM:


Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • serum TBARS [ Time Frame: end of week 1, 3, 5 and 9 ] [ Designated as safety issue: No ]
    an indicator of MDA levels, and therefore, lipid peroxidation


Secondary Outcome Measures:
  • serum antioxidant capacity (AOC) [ Time Frame: end of week 1, 3, 5 and 9 ] [ Designated as safety issue: No ]
    measured using the TEAC-ABTS radical cation assay

  • serum thiols [ Time Frame: end of week 1, 3, 5 and 9 ] [ Designated as safety issue: No ]
    measured using the DTNB assay, as an indicator of antioxidant levels in protein fraction


Enrollment: 24
Study Start Date: March 2009
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: one-cup Dietary Supplement: individually quick frozen red raspberries
Consumption of one-cup frozen red raspberries daily for four weeks, followed by a four week period of non-treatment.
Experimental: two-cups Dietary Supplement: individually quick frozen red raspberries
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.
Experimental: four-cups Dietary Supplement: individually quick frozen red raspberries
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 43 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00876811

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 Department of Nutritional Sciences, 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: NCT00876811     History of Changes
Other Study ID Numbers: 22069
Study First Received: April 3, 2009
Last Updated: October 28, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Toronto:
raspberry
fruit
antioxidants
polyphenols
oxidative stress
dietary intervention

ClinicalTrials.gov processed this record on October 20, 2014