Clinical trial NCT01440790: The Effect of Continuous Sipping of a Glucose Solution on Markers of Oxidation in Men and Women
Official title: The Effect of Continuous Sipping of a Glucose Solution on Markers of Oxidation in Men and Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Diabetes
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2011-09-27
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: Inclusion Criteria:

* healthy males or females
* 18 to 75 years

Exclusion Criteria:

* diabetes
* recent hospitalization

Primary outcomes:
measure: Incremental Area Under the Curve over 4 hours in serum TRAP (total peroxyl radical-trapping potential)
timeFrame: Four (4) hours after starting to eat the test meal.
Secondary outcomes:
measure: Change over 6 hours from baseline in Plasma glucose
timeFrame: Baseline and 30, 60, 120, 180, 240, 270, 300 and 360min
measure: Change over 6 hours from baseline in Plasma insulin
timeFrame: Baseline and 30, 60, 120, 180, 240, 270, 300 and 360min
measure: Change over 6 hours from baseline in Plasma free-fatty acids
timeFrame: Baseline and hourly for 6h
measure: Change over 6 hours from baseline in Serum vitamin C
timeFrame: Baseline and 2, 4 and 6h
measure: Change over 6 hours from baseline in C-reactive protein
timeFrame: Baseline and 2, 4 and 6h
measure: Change over 6 hours from baseline in Blood pressure
timeFrame: Baseline and 1, 2, 4, 5 and 6h
measure: Change over 6 hours from baseline in Pulse
timeFrame: Baseline and 1, 2, 4, 5 and 6h
measure: Change over 6 hours from baseline in Pulse pressure
timeFrame: Baseline and 1, 2, 4, 5 and 6h
measure: Change over 6 hours from baseline in Augmentation index
timeFrame: Baseline and 1, 2, 4, 5 and 6h
measure: Change over 6 hours from baseline in Oxidized LDL
timeFrame: Baseline and hourly for 6hr
measure: Change from baseline in serum TRAP over 6 hours
timeFrame: Baseline and 30, 60, 120, 180, 240, 270, 300 and 360min
Other outcomes:
Locations:
Study officials:
affiliation: University of Toronto
name: Thomas MS Wolever, BMBCh PhD DM
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto
name: Shannan Grant, MSc, RD
role: STUDY_DIRECTOR
References: