NCT01242033

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 16, 2010

Completed
Last Updated

December 6, 2010

Status Verified

November 1, 2010

Enrollment Period

28 days

First QC Date

November 8, 2010

Last Update Submit

December 3, 2010

Conditions

Keywords

red raspberriespost-prandialoxidative stressantioxidantspolyphenolsvitamin Cacute dietary intervention

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • change in lipid peroxidation from baseline (-0.25 h)

    -0.25, 0.25, 0.5, 1, 2, 4 hours post-intake

  • change in thiols compared to baseline (-0.25 h)

    -025, 0.25, 0.5, 1, 2, 4 hours post-intake

Study Arms (5)

one cup red raspberries

EXPERIMENTAL

treatment meal consists of one cup red raspberries

Dietary Supplement: red raspberries

two cups red raspberries

EXPERIMENTAL

treatment meal consists of two cups red raspberries

Dietary Supplement: red raspberries

four cups red raspberries

EXPERIMENTAL

treatment meal consists of four cups red raspberries

Dietary Supplement: red raspberries

bread

PLACEBO COMPARATOR

treatment meal consists of two slices white bread

Dietary Supplement: bread controls

vitamin C

ACTIVE COMPARATOR

treatment meal consists of two slices white bread and 200 mg vitamin C in the form of supplemental ascorbic acid

Dietary Supplement: bread controls

Interventions

red raspberriesDIETARY_SUPPLEMENT

single serving of one, two or four cups red raspberries

four cups red raspberriesone cup red raspberriestwo cups red raspberries
bread controlsDIETARY_SUPPLEMENT

two slices white bread alone or with 200 mg vitamin C supplement

breadvitamin C

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy adults

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Nutrition and Risk Factor Modification Centre; St. Michael's Hospital

Toronto, Ontario, M5C 2T2, Canada

Location

Study Officials

  • A V Rao, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 8, 2010

First Posted

November 16, 2010

Study Start

February 1, 2010

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

December 6, 2010

Record last verified: 2010-11

Locations