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

Diabetes Clinical Trial

— AOGI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01440790
• Other study ID #: 25401TW
• Status: Completed
• Phase: N/A
• First received: August 3, 2011
• Last updated: March 11, 2013
• Start date: August 2010
• Est. completion date: June 2011

Study information

• Verified date: March 2013
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review CommitteeCanada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• healthy males or females

• 18 to 75 years

Exclusion Criteria:

• diabetes

• recent hospitalization

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Toronto	Canadian Institutes of Health Research (CIHR)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Change over 6 hours from baseline in Plasma glucose		Baseline and 30, 60, 120, 180, 240, 270, 300 and 360min	No
Secondary	Change over 6 hours from baseline in Plasma insulin		Baseline and 30, 60, 120, 180, 240, 270, 300 and 360min	No
Secondary	Change over 6 hours from baseline in Plasma free-fatty acids		Baseline and hourly for 6h	No
Secondary	Change over 6 hours from baseline in Serum vitamin C		Baseline and 2, 4 and 6h	No
Secondary	Change over 6 hours from baseline in C-reactive protein		Baseline and 2, 4 and 6h	No
Secondary	Change over 6 hours from baseline in Blood pressure		Baseline and 1, 2, 4, 5 and 6h	No
Secondary	Change over 6 hours from baseline in Pulse		Baseline and 1, 2, 4, 5 and 6h	No
Secondary	Change over 6 hours from baseline in Pulse pressure		Baseline and 1, 2, 4, 5 and 6h	No
Secondary	Change over 6 hours from baseline in Augmentation index		Baseline and 1, 2, 4, 5 and 6h	No
Secondary	Change over 6 hours from baseline in Oxidized LDL		Baseline and hourly for 6hr	No
Secondary	Change from baseline in serum TRAP over 6 hours		Baseline and 30, 60, 120, 180, 240, 270, 300 and 360min	No