Cardiovascular DiseaseAOGINCT01440790
The Effect of Continuous Sipping of a Glucose Solution on Markers of Oxidation in Men and Women
A study testing glucose bolus, Glucose sipping and Glucose bolus plus 1g vitamin C in people with Cardiovascular Disease and Diabetes, run by University of Toronto.
Trial summary
The objective of this study is to determine the effect of reducing the rate of glucose absorption on oxidative stress after eating and to compare it with the effects of vitamin C. The hypothesis is that reducing the rate of glucose absorption will reduce oxidative stress to a similar extent as 1g vitamin C. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, Diabetes
- What is being tested?
- glucose bolus, Glucose sipping and Glucose bolus plus 1g vitamin C
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Jun 2011
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy males or females
- 18 to 75 years
Who cannot join
- diabetes
- recent hospitalization
About this study
The objective of this study is to determine the effect of reducing the rate of glucose absorption on oxidative stress after eating and to compare it with the effects of vitamin C. The hypothesis is that reducing the rate of glucose absorption will reduce oxidative stress to a similar extent as 1g vitamin C.
Read the detailed description
Recently, much attention has been paid to evidence that abnormalities of the postprandial state (hyperglycemia) are important contributing factors to the development of chronic disease. This attention has increased interest in the role low glycemic index (GI) foods could potentially play in preventing postprandial oxidative burst/stress. GI is a means by which to categorize carbohydrate according to their postprandial glycemic response. Low GI foods promote slow intestinal absorption, prolonged and less pronounced postprandial glycemia, may decrease risk of chronic disease, as well as provide metabolic benefit to people living with glucose abnormalities as well as those with normal glucose. Few studies have been conducted looking at the potential relationship between GI and oxidation and are limited by dietary/lifestyle confounders. The proposed study has been developed to eliminate these confounders. Hypotheses (3): 1. Sipping glucose slowly over 3h will result in less oxidative stress than ingesting the same amount of glucose as a bolus over 5min. 2. Sipping glucose will reduce oxidative stress to the same extent as 1g of oral vitamin C. 3. The effect of sipping glucose on oxidative stress will occur sooner than that of vitamin C.
- Conditions
- Cardiovascular Disease, Diabetes
- Being tested
- glucose bolus, Glucose sipping, Glucose bolus plus 1g vitamin C, Glucose sipping plus 1g vitamin C
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glucose bolusDietary supplement
50g anhydrous glucose dissolved in 300ml water consumed within 10min followed by a lunch (cheese sandwich, fruit and milk) at 4h.
Glucose sippingDietary supplement
50g anhydrous glucose dissolved in 300ml water consumed at rate of 25ml per 15min followed by a lunch (cheese sandwich, fruit and milk) at 4h.
Glucose bolus plus 1g vitamin CDietary supplement
50g anhydrous glucose dissolved in 300ml water consumed within 10min with 1g vitamin C followed by a lunch (cheese sandwich, fruit and milk) at 4h.
Glucose sipping plus 1g vitamin CDietary supplement
50g anhydrous glucose dissolved in 300ml water consumed at rate of 25ml per 15min. 1g vitamin C taken with first 25ml. Followed by a lunch (cheese sandwich, fruit and milk) at 4h.
| Study group | Role | What they receive |
|---|---|---|
| Glucose bolus alone | Placebo comparator | 50g glucose dissolved in water and consumed within 5 minutes. Receives: Dietary Supplement: glucose bolus |
| Glucose sipping alone | Experimental | 50g glucose dissolved in water and consumed gradually over 3 hours. Receives: Dietary Supplement: Glucose sipping |
| Glucose bolus plus 1g vitamin C | Active comparator | 50g glucose dissolved in water and consumed in 5 minutes with 1g vitamin C Receives: Dietary Supplement: Glucose bolus plus 1g vitamin C |
| Glucose sipping plus 1g vitamin C | Experimental | 50g glucose dissolved in water and consumed gradually of 3 hours. In addition 1g vitamin C will be taken with the first mouthful of glucose solution. Receives: Dietary Supplement: Glucose sipping plus 1g vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental Area Under the Curve over 4 hours in serum TRAP (total peroxyl radical-trapping potential)
Measured: Four (4) hours after starting to eat the test meal.
Secondary outcomes (11)
Change over 6 hours from baseline in Plasma glucose
Measured: Baseline and 30, 60, 120, 180, 240, 270, 300 and 360min
Change over 6 hours from baseline in Plasma insulin
Measured: Baseline and 30, 60, 120, 180, 240, 270, 300 and 360min
Change over 6 hours from baseline in Plasma free-fatty acids
Measured: Baseline and hourly for 6h
Change over 6 hours from baseline in Serum vitamin C
Measured: Baseline and 2, 4 and 6h
Change over 6 hours from baseline in C-reactive protein
Measured: Baseline and 2, 4 and 6h
Change over 6 hours from baseline in Blood pressure
Measured: Baseline and 1, 2, 4, 5 and 6h
Change over 6 hours from baseline in Pulse
Measured: Baseline and 1, 2, 4, 5 and 6h
Change over 6 hours from baseline in Pulse pressure
Measured: Baseline and 1, 2, 4, 5 and 6h
Change over 6 hours from baseline in Augmentation index
Measured: Baseline and 1, 2, 4, 5 and 6h
Change over 6 hours from baseline in Oxidized LDL
Measured: Baseline and hourly for 6hr
Change from baseline in serum TRAP over 6 hours
Measured: Baseline and 30, 60, 120, 180, 240, 270, 300 and 360min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2011 (estimated)
- Study startAug 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Thomas Wolever, University of Toronto
- Investigators
- Thomas MS Wolever, BMBCh PhD DM, Principal investigator, University of TorontoShannan Grant, MSc, RD, Study director, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01440790
- Sponsor's protocol ID
- 25401TW
- Acronym
- AOGI
- Status last verified
- Mar 2013
- First submitted
- 3 Aug 2011
- Last updated
- 12 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Continuous Sipping of a Glucose Solution on Markers of Oxidation in Men and Women
- ClinicalTrials.gov ID
- NCT01440790
- Acronym / sponsor ID
- AOGI / 25401TW
- Conditions
- Cardiovascular Disease, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Aug 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 27 Sep 2011 (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.
The objective of this study is to determine the effect of reducing the rate of glucose absorption on oxidative stress after eating and to compare it with the effects of vitamin C. The hypothesis is that reducing the rate of glucose absorption will reduce oxidative stress to a similar extent as 1g vitamin C.
Detailed description
Recently, much attention has been paid to evidence that abnormalities of the postprandial state (hyperglycemia) are important contributing factors to the development of chronic disease. This attention has increased interest in the role low glycemic index (GI) foods could potentially play in preventing postprandial oxidative burst/stress. GI is a means by which to categorize carbohydrate according to their postprandial glycemic response. Low GI foods promote slow intestinal absorption, prolonged and less pronounced postprandial glycemia, may decrease risk of chronic disease, as well as provide metabolic benefit to people living with glucose abnormalities as well as those with normal glucose. Few studies have been conducted looking at the potential relationship between GI and oxidation and are limited by dietary/lifestyle confounders. The proposed study has been developed to eliminate these confounders. Hypotheses (3): 1. Sipping glucose slowly over 3h will result in less oxidative stress than ingesting the same amount of glucose as a bolus over 5min. 2. Sipping glucose will reduce oxidative stress to the same extent as 1g of oral vitamin C. 3. The effect of sipping glucose on oxidative stress will occur sooner than that of vitamin C.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Glucose bolus alone | Placebo comparator | Dietary Supplement: glucose bolus50g glucose dissolved in water and consumed within 5 minutes. |
| Glucose sipping alone | Experimental | Dietary Supplement: Glucose sipping50g glucose dissolved in water and consumed gradually over 3 hours. |
| Glucose bolus plus 1g vitamin C | Active comparator | Dietary Supplement: Glucose bolus plus 1g vitamin C50g glucose dissolved in water and consumed in 5 minutes with 1g vitamin C |
| Glucose sipping plus 1g vitamin C | Experimental | Dietary Supplement: Glucose sipping plus 1g vitamin C50g glucose dissolved in water and consumed gradually of 3 hours. In addition 1g vitamin C will be taken with the first mouthful of glucose solution. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy males or females
- 18 to 75 years
Key exclusion criteria (2 listed)
- diabetes
- recent hospitalization
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 |
|---|---|---|
| glucose bolus50g anhydrous glucose dissolved in 300ml water consumed within 10min followed by a lunch (cheese sandwich, fruit and milk) at 4h. | Dietary supplement | Glucose bolus alone |
| Glucose sipping50g anhydrous glucose dissolved in 300ml water consumed at rate of 25ml per 15min followed by a lunch (cheese sandwich, fruit and milk) at 4h. | Dietary supplement | Glucose sipping alone |
| Glucose bolus plus 1g vitamin C50g anhydrous glucose dissolved in 300ml water consumed within 10min with 1g vitamin C followed by a lunch (cheese sandwich, fruit and milk) at 4h. | Dietary supplement | Glucose bolus plus 1g vitamin C |
| Glucose sipping plus 1g vitamin C50g anhydrous glucose dissolved in 300ml water consumed at rate of 25ml per 15min. 1g vitamin C taken with first 25ml. Followed by a lunch (cheese sandwich, fruit and milk) at 4h. | Dietary supplement | Glucose sipping plus 1g vitamin C |
Primary outcome
Incremental Area Under the Curve over 4 hours in serum TRAP (total peroxyl radical-trapping potential)
Time frame: Four (4) hours after starting to eat the test meal.
11 secondary outcomes
Change over 6 hours from baseline in Plasma glucose
Time frame: Baseline and 30, 60, 120, 180, 240, 270, 300 and 360min
Change over 6 hours from baseline in Plasma insulin
Time frame: Baseline and 30, 60, 120, 180, 240, 270, 300 and 360min
Change over 6 hours from baseline in Plasma free-fatty acids
Time frame: Baseline and hourly for 6h
Change over 6 hours from baseline in Serum vitamin C
Time frame: Baseline and 2, 4 and 6h
Change over 6 hours from baseline in C-reactive protein
Time frame: Baseline and 2, 4 and 6h
Change over 6 hours from baseline in Blood pressure
Time frame: Baseline and 1, 2, 4, 5 and 6h
Change over 6 hours from baseline in Pulse
Time frame: Baseline and 1, 2, 4, 5 and 6h
Change over 6 hours from baseline in Pulse pressure
Time frame: Baseline and 1, 2, 4, 5 and 6h
Change over 6 hours from baseline in Augmentation index
Time frame: Baseline and 1, 2, 4, 5 and 6h
Change over 6 hours from baseline in Oxidized LDL
Time frame: Baseline and hourly for 6hr
Change from baseline in serum TRAP over 6 hours
Time frame: Baseline and 30, 60, 120, 180, 240, 270, 300 and 360min
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 12 Mar 2013.
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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.
Thomas MS Wolever, BMBCh PhD DM principal investigator
University of Toronto
Shannan Grant, MSc, RD study director
University of Toronto
Questions about this trial
What is this clinical trial studying?
A study testing glucose bolus, Glucose sipping and Glucose bolus plus 1g vitamin C in people with Cardiovascular Disease and Diabetes, run by University of Toronto.
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 2 inclusion and 2 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 12 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Incremental Area Under the Curve over 4 hours in serum TRAP (total peroxyl radical-trapping potential) (time frame: Four (4) hours after starting to eat the test meal.). 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 12 Mar 2013.