Oxidative StressNCT01242033
Effect of Acute Red Raspberry Consumption on Post-prandial Oxidative Stress
A study testing red raspberries in people with Oxidative Stress and Antioxidants, run by University of Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress, Antioxidants
- What is being tested?
- red raspberries
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2010to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy adults
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Clinical Nutrition and Risk Factor Modification Centre; St. Michael's Hospital
Toronto, Ontario, M5C 2T2
About this study
Official title: An Acute Intervention Study Investigating the Effect of Red Raspberry Consumption on Post-prandial Oxidative Stress
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.
- Conditions
- Oxidative Stress, Antioxidants
- Being tested
- red raspberries, bread controls
- Keywords
- red raspberries, post-prandial, oxidative stress, antioxidants, polyphenols, vitamin C, acute dietary intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
red raspberriesDietary supplement
single serving of one, two or four cups red raspberries
bread controlsDietary supplement
two slices white bread alone or with 200 mg vitamin C supplement
| Study group | Role | What they receive |
|---|---|---|
| one cup red raspberries | Experimental | treatment meal consists of one cup red raspberries Receives: Dietary Supplement: red raspberries |
| two cups red raspberries | Experimental | treatment meal consists of two cups red raspberries Receives: Dietary Supplement: red raspberries |
| four cups red raspberries | Experimental | treatment meal consists of four cups red raspberries Receives: Dietary Supplement: red raspberries |
| bread | Placebo comparator | treatment meal consists of two slices white bread Receives: 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 Receives: Dietary Supplement: bread controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: -0.25, 0.25, 0.5, 1, 2, 4 hours post-intake
Secondary outcomes (2)
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)
Measured: -0.25, 0.25, 0.5, 1, 2, 4 hours post-intake
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
Measured: -025, 0.25, 0.5, 1, 2, 4 hours post-intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2010 (estimated)
- Study startFeb 2010
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Unity Health Toronto
- Investigators
- A V Rao, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01242033
- Sponsor's protocol ID
- 24774
- Status last verified
- Nov 2010
- First submitted
- 8 Nov 2010
- Last updated
- 6 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Acute Intervention Study Investigating the Effect of Red Raspberry Consumption on Post-prandial Oxidative Stress
- ClinicalTrials.gov ID
- NCT01242033
- Acronym / sponsor ID
- 24774
- Conditions
- Oxidative Stress, Antioxidants
- Keywords
- red raspberries, post-prandial, oxidative stress, antioxidants, polyphenols, vitamin C, acute dietary intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Unity Health Toronto
- Study start
- Feb 2010
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 16 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| one cup red raspberries | Experimental | Dietary Supplement: red raspberriestreatment meal consists of one cup red raspberries |
| two cups red raspberries | Experimental | Dietary Supplement: red raspberriestreatment meal consists of two cups red raspberries |
| four cups red raspberries | Experimental | Dietary Supplement: red raspberriestreatment meal consists of four cups red raspberries |
| bread | Placebo comparator | Dietary Supplement: bread controlstreatment meal consists of two slices white bread |
| vitamin C | Active comparator | Dietary Supplement: bread controlstreatment meal consists of two slices white bread and 200 mg vitamin C in the form of supplemental ascorbic acid |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy adults
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| red raspberriessingle serving of one, two or four cups red raspberries | Dietary supplement | four cups red raspberries, one cup red raspberries, two cups red raspberries |
| bread controlstwo slices white bread alone or with 200 mg vitamin C supplement | Dietary supplement | bread, vitamin C |
Primary outcome
change in antioxidant capacity from baseline (-0.25 h)
Time frame: -0.25, 0.25, 0.5, 1, 2, 4 hours post-intake
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)
2 secondary outcomes
change in lipid peroxidation from baseline (-0.25 h)
Time frame: -0.25, 0.25, 0.5, 1, 2, 4 hours post-intake
change in thiols compared to baseline (-0.25 h)
Time frame: -025, 0.25, 0.5, 1, 2, 4 hours post-intake
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2010.
Related trials for Oxidative Stress
Active, not recruitingPhase 2
Effect of a Parenteral Emulsion With Omega3 on Neonates With PPHN and CDH
Pulmonary Hypertension of Newborn, Diaphragm Defect
Active, not recruiting
Efficacy of MAGNESIO TOTAL on Sleep Quality and Quality of Life in Adults
Sleep Quality, Magnesium Deficiency
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
Not yet recruitingObservational study
Vascular Health and Function in Cystic Fibrosis
Cystic Fibrosis, Endothelial Dysfunction
Not yet recruiting
The Effects of Manual Acupuncture on Superoxide Dismutase Enzyme Activity and Questionnaire of Smoking Urges-Brief Scores in Active Smokers: A Randomized Controlled Trial
Superoxide Dismutase, Acupuncture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A V Rao, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing red raspberries in people with Oxidative Stress and Antioxidants, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in antioxidant capacity from baseline (-0.25 h) (time frame: -0.25, 0.25, 0.5, 1, 2, 4 hours post-intake). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2010.