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

Not Applicable

Completed

• Conditions: Cardiovascular Disease; Diabetes

• Registration Number: NCT01440790
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2010-08
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Study First Submitted: 2011-08-03
• Study First Submitted QC: 2011-09-23
• Study First Posted: 2011-09-27
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-11
• Last Update Posted: 2013-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• healthy males or females
• 18 to 75 years

Exclusion Criteria

• diabetes
• recent hospitalization

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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