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

NCT01440790 | Completed

• 1 other identifier: 25401TW
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cardiovascular Disease; Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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

Study Arms (4)

Glucose bolus alone

PLACEBO COMPARATOR

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

Dietary Supplement: glucose bolus

Glucose sipping alone

EXPERIMENTAL

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

Dietary Supplement: Glucose sipping

Glucose bolus plus 1g vitamin C

ACTIVE COMPARATOR

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

Dietary Supplement: Glucose bolus plus 1g vitamin C

Glucose sipping plus 1g vitamin C

EXPERIMENTAL

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

Interventions

glucose bolus DIETARY_SUPPLEMENT

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

Glucose bolus alone

Glucose sipping DIETARY_SUPPLEMENT

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 sipping alone

Glucose bolus plus 1g vitamin C DIETARY_SUPPLEMENT

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 bolus plus 1g vitamin C

Glucose sipping plus 1g vitamin C DIETARY_SUPPLEMENT

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.

Glucose sipping plus 1g vitamin C

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy males or females
• to 75 years

You may not qualify if:

• diabetes
• recent hospitalization

Sponsors & Collaborators

• University of Toronto: lead
• Canadian Institutes of Health Research (CIHR): collaborator

MeSH Terms

Conditions

Cardiovascular Diseases; Diabetes Mellitus

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Thomas MS Wolever, BMBCh PhD DM

  University of Toronto

  PRINCIPAL INVESTIGATOR

• Shannan Grant, MSc, RD

  University of Toronto

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 3, 2011
• First Posted: September 27, 2011
• Study Start: August 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: March 12, 2013

Record last verified: 2013-03