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

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

Sponsors

Lead Sponsor: University of Toronto

Collaborator: Canadian Institutes of Health Research (CIHR)

Source University of Toronto
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.

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.

Overall Status Completed
Start Date August 2010
Completion Date June 2011
Primary Completion Date June 2011
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Incremental Area Under the Curve over 4 hours in serum TRAP (total peroxyl radical-trapping potential) Four (4) hours after starting to eat the test meal.
Secondary Outcome
Measure Time Frame
Change over 6 hours from baseline in Plasma glucose Baseline and 30, 60, 120, 180, 240, 270, 300 and 360min
Change over 6 hours from baseline in Plasma insulin Baseline and 30, 60, 120, 180, 240, 270, 300 and 360min
Change over 6 hours from baseline in Plasma free-fatty acids Baseline and hourly for 6h
Change over 6 hours from baseline in Serum vitamin C Baseline and 2, 4 and 6h
Change over 6 hours from baseline in C-reactive protein Baseline and 2, 4 and 6h
Change over 6 hours from baseline in Blood pressure Baseline and 1, 2, 4, 5 and 6h
Change over 6 hours from baseline in Pulse Baseline and 1, 2, 4, 5 and 6h
Change over 6 hours from baseline in Pulse pressure Baseline and 1, 2, 4, 5 and 6h
Change over 6 hours from baseline in Augmentation index Baseline and 1, 2, 4, 5 and 6h
Change over 6 hours from baseline in Oxidized LDL Baseline and hourly for 6hr
Change from baseline in serum TRAP over 6 hours Baseline and 30, 60, 120, 180, 240, 270, 300 and 360min
Enrollment 18
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: glucose bolus

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

Arm Group Label: Glucose bolus alone

Intervention Type: Dietary Supplement

Intervention Name: Glucose sipping

Description: 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.

Arm Group Label: Glucose sipping alone

Intervention Type: Dietary Supplement

Intervention Name: Glucose bolus plus 1g vitamin C

Description: 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.

Arm Group Label: Glucose bolus plus 1g vitamin C

Intervention Type: Dietary Supplement

Intervention Name: Glucose sipping plus 1g vitamin C

Description: 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.

Arm Group Label: Glucose sipping plus 1g vitamin C

Eligibility

Criteria:

Inclusion Criteria:

- healthy males or females

- 18 to 75 years

Exclusion Criteria:

- diabetes

- recent hospitalization

Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Verification Date

March 2013

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Toronto

Investigator Full Name: Thomas Wolever

Investigator Title: Professor

Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: Glucose bolus alone

Type: Placebo Comparator

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

Label: Glucose sipping alone

Type: Experimental

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

Label: Glucose bolus plus 1g vitamin C

Type: Active Comparator

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

Label: Glucose sipping plus 1g vitamin C

Type: Experimental

Description: 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.

Acronym AOGI
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Basic Science

Masking: None (Open Label)

Source: ClinicalTrials.gov