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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cardiovascular Disease, Diabetes

Intervention / Treatment
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* Dietary Supplement: glucose bolus
* Dietary Supplement: Glucose sipping
* Dietary Supplement: Glucose bolus plus 1g vitamin C
* Dietary Supplement: Glucose sipping plus 1g vitamin C


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy males or females 18 to 75 years Exclusion Criteria: diabetes recent hospitalization

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Glucose bolus alone<br>50g glucose dissolved in water and consumed within 5 minutes. | Dietary Supplement: glucose bolus<br>* 50g anhydrous glucose dissolved in 300ml water consumed within 10min followed by a lunch (cheese sandwich, fruit and milk) at 4h.<br>|
| Experimental: Glucose sipping alone<br>50g glucose dissolved in water and consumed gradually over 3 hours. | Dietary Supplement: Glucose sipping<br>* 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.<br>|
| Active Comparator: Glucose bolus plus 1g vitamin C<br>50g glucose dissolved in water and consumed in 5 minutes with 1g vitamin C | Dietary Supplement: Glucose bolus plus 1g vitamin C<br>* 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.<br>|
| Experimental: Glucose sipping plus 1g vitamin C<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Measures

| Outcome Measure | Measure Description | 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 |