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Completed

NCT Number: NCT01440790

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy males or females
  • 18 to 75 years

Exclusion criteria

  • diabetes
  • recent hospitalization

Treatment and study plan

glucose bolus

Dietary Supplement

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

Glucose sipping

Dietary 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 C

Dietary 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 C

Dietary 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.

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

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Acronym: AOGI

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 27, 2011
Registry last updated
Mar 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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