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

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Thomas Wolever, University of Toronto
ClinicalTrials.gov Identifier:
NCT01440790
First received: August 3, 2011
Last updated: March 11, 2013
Last verified: March 2013
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change over 6 hours from baseline in Plasma glucose [ Time Frame: Baseline and 30, 60, 120, 180, 240, 270, 300 and 360min ] [ Designated as safety issue: No ]
  • Change over 6 hours from baseline in Plasma insulin [ Time Frame: Baseline and 30, 60, 120, 180, 240, 270, 300 and 360min ] [ Designated as safety issue: No ]
  • Change over 6 hours from baseline in Plasma free-fatty acids [ Time Frame: Baseline and hourly for 6h ] [ Designated as safety issue: No ]
  • Change over 6 hours from baseline in Serum vitamin C [ Time Frame: Baseline and 2, 4 and 6h ] [ Designated as safety issue: No ]
  • Change over 6 hours from baseline in C-reactive protein [ Time Frame: Baseline and 2, 4 and 6h ] [ Designated as safety issue: No ]
  • Change over 6 hours from baseline in Blood pressure [ Time Frame: Baseline and 1, 2, 4, 5 and 6h ] [ Designated as safety issue: No ]
  • Change over 6 hours from baseline in Pulse [ Time Frame: Baseline and 1, 2, 4, 5 and 6h ] [ Designated as safety issue: No ]
  • Change over 6 hours from baseline in Pulse pressure [ Time Frame: Baseline and 1, 2, 4, 5 and 6h ] [ Designated as safety issue: No ]
  • Change over 6 hours from baseline in Augmentation index [ Time Frame: Baseline and 1, 2, 4, 5 and 6h ] [ Designated as safety issue: No ]
  • Change over 6 hours from baseline in Oxidized LDL [ Time Frame: Baseline and hourly for 6hr ] [ Designated as safety issue: No ]
  • Change from baseline in serum TRAP over 6 hours [ Time Frame: Baseline and 30, 60, 120, 180, 240, 270, 300 and 360min ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: August 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy males or females
  • 18 to 75 years

Exclusion Criteria:

  • diabetes
  • recent hospitalization
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Thomas Wolever, Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT01440790     History of Changes
Other Study ID Numbers: 25401TW
Study First Received: August 3, 2011
Last Updated: March 11, 2013
Health Authority: Canada: Ethics Review Committee
Canada: Canadian Institutes of Health Research

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

ClinicalTrials.gov processed this record on October 20, 2014