Effect of Red Raspberry Consumption on Fasting Oxidative Stress Biomarkers

Oxidative Stress Clinical Trial

Official title:

Raspberries and Human Health: A Short-term Intervention Trial Investigating the Effect of Daily Red Raspberry Consumption on Fasting Oxidative Stress Biomarkers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00876811
• Other study ID #: 22069
• Status: Completed
• Phase: Phase 1
• First received: April 3, 2009
• Last updated: October 28, 2010
• Start date: March 2009
• Est. completion date: May 2009

Study information

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

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 43 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Oxidative Stress

Intervention

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.
• 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.
• 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.

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	serum TBARS	an indicator of MDA levels, and therefore, lipid peroxidation	end of week 1, 3, 5 and 9	No
Secondary	serum antioxidant capacity (AOC)	measured using the TEAC-ABTS radical cation assay	end of week 1, 3, 5 and 9	No
Secondary	serum thiols	measured using the DTNB assay, as an indicator of antioxidant levels in protein fraction	end of week 1, 3, 5 and 9	No