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

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ClinicalTrials.gov Identifier: NCT01440790
Recruitment Status : Completed
First Posted : September 27, 2011
Last Update Posted : March 12, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Cardiovascular Disease Diabetes Dietary Supplement: glucose bolus Dietary Supplement: Glucose sipping Dietary Supplement: Glucose bolus plus 1g vitamin C Dietary Supplement: Glucose sipping plus 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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effect of Continuous Sipping of a Glucose Solution on Markers of Oxidation in Men and Women
Study Start Date : August 2010
Primary Completion Date : June 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin C
Drug Information available for: Dextrose
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Glucose bolus alone
50g glucose dissolved in water and consumed within 5 minutes.
Dietary Supplement: glucose bolus
50g anhydrous glucose dissolved in 300ml water consumed within 10min followed by a lunch (cheese sandwich, fruit and milk) at 4h.
Experimental: Glucose sipping alone
50g glucose dissolved in water and consumed gradually over 3 hours.
Dietary Supplement: Glucose 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.
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
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.
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
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.


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy males or females
  • 18 to 75 years

Exclusion Criteria:

  • diabetes
  • recent hospitalization
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01440790


Sponsors and Collaborators
University of Toronto
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Thomas MS Wolever, BMBCh PhD DM University of Toronto
Study Director: Shannan Grant, MSc, RD University of Toronto
More Information

Responsible Party: Thomas Wolever, Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT01440790     History of Changes
Other Study ID Numbers: 25401TW
First Posted: September 27, 2011    Key Record Dates
Last Update Posted: March 12, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Cardiovascular Diseases
Vitamins
Ascorbic Acid
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents