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CompletedNCT01440790AOGIUpdated Mar 12, 2013

The Effect of Continuous Sipping of a Glucose Solution on Markers of Oxidation in Men and Women

An interventional study of glucose bolus and Glucose sipping in Cardiovascular Disease and Diabetes, sponsored by University of Toronto. Completed. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-03-12.

Sponsored by University of Toronto · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Cardiovascular Disease
  • Diabetes
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's enrollment of 18 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

University of Toronto is the lead sponsor of 397 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • healthy males or females
  • 18 to 75 years

Exclusion criteria

Exclusion Criteria:

  • diabetes
  • recent hospitalization
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Placebo comparator
    Glucose bolus alone

    50g glucose dissolved in water and consumed within 5 minutes.

    Dietary Supplement: glucose bolus

  • Experimental
    Glucose sipping alone

    50g glucose dissolved in water and consumed gradually over 3 hours.

    Dietary Supplement: Glucose sipping

  • Active comparator
    Glucose bolus plus 1g vitamin C

    50g glucose dissolved in water and consumed in 5 minutes with 1g vitamin C

    Dietary Supplement: Glucose bolus plus 1g vitamin C

  • Experimental
    Glucose sipping plus 1g vitamin C

    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.

    Dietary Supplement: Glucose sipping plus 1g vitamin C

Interventions

  • Dietary supplementglucose bolus

    50g anhydrous glucose dissolved in 300ml water consumed within 10min followed by a lunch (cheese sandwich, fruit and milk) at 4h.

  • Dietary supplementGlucose sipping

    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.

  • Dietary supplementGlucose bolus plus 1g vitamin C

    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.

  • Dietary supplementGlucose sipping plus 1g vitamin C

    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.

06

What researchers measure

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change over 6 hours from baseline in Plasma glucose

    Time frame: Baseline and 30, 60, 120, 180, 240, 270, 300 and 360min

  2. Change over 6 hours from baseline in Plasma insulin

    Time frame: Baseline and 30, 60, 120, 180, 240, 270, 300 and 360min

  3. Change over 6 hours from baseline in Plasma free-fatty acids

    Time frame: Baseline and hourly for 6h

  4. Change over 6 hours from baseline in Serum vitamin C

    Time frame: Baseline and 2, 4 and 6h

  5. Change over 6 hours from baseline in C-reactive protein

    Time frame: Baseline and 2, 4 and 6h

  6. Change over 6 hours from baseline in Blood pressure

    Time frame: Baseline and 1, 2, 4, 5 and 6h

  7. Change over 6 hours from baseline in Pulse

    Time frame: Baseline and 1, 2, 4, 5 and 6h

  8. Change over 6 hours from baseline in Pulse pressure

    Time frame: Baseline and 1, 2, 4, 5 and 6h

  9. Change over 6 hours from baseline in Augmentation index

    Time frame: Baseline and 1, 2, 4, 5 and 6h

  10. Change over 6 hours from baseline in Oxidized LDL

    Time frame: Baseline and hourly for 6hr

  11. Change from baseline in serum TRAP over 6 hours

    Time frame: Baseline and 30, 60, 120, 180, 240, 270, 300 and 360min

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01440790
Lead sponsor
University of Toronto
Collaborators
Canadian Institutes of Health Research (CIHR)
Responsible party
Thomas Wolever (Professor, University of Toronto) — Principal investigator
First posted
Sep 27, 2011
Start date
Aug 2010
Primary completion
Jun 2011
Completion
Jun 2011
Last update
Mar 12, 2013

Study contacts

Thomas MS Wolever, BMBCh PhD DM
principal investigator · University of Toronto
Shannan Grant, MSc, RD
study director · University of Toronto

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

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