Acute Vascular Response To Meals Varying In Glycemic Index And Glycemic Load

Phase 2

• Conditions: Healthy
• Interventions: Other: Boiled Pasta; Other: Boiled Chickpeas with Oil; Other: Instant Mashed Potatoes; Other: Instant Mashed Potatoes with Egg Whites

• Registration Number: NCT01883700
• Lead Sponsor: Unity Health Toronto

Brief Summary

This study examines the effects of carbohydrate type (high- or low-Glycemic Index (GI)) and amount (high- or low-Glycemic Load (GL)) have on blood glucose levels, blood pressure and arterial stiffness in healthy individuals. It will also determine whether subjective ratings such as test meal palatability and hunger are related to changes in blood glucose. The investigators hypothesize that: (1) High-GI meals, regardless of GL, will increase arterial stiffness; low-GI meals, regardless of GL, will have a neutral or lowering effect on arterial stiffness (augmentation index). (2) High-GI meals, regardless of GL, will have an elevating effect on both central and peripheral blood pressures. (3) The incremental area under the curve for blood glucose will show most significant differences between high-GI, high-GL and low-GI, low-GL meals at 30 and 90 min.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Primary Completion: 2011-09
• Study First Submitted: 2013-02-22
• Status Verified: 2013-06
• Study First Submitted QC: 2013-06-19
• Last Update Submitted: 2013-06-19
• Study First Posted: 2013-06-21
• Last Update Posted: 2013-06-21
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• healthy
• age 18 - 75 years
• BMI 18 - 25 kg/m2
• brachial systolic blood pressure < 140 mmHg
• brachial diastolic blood pressure < 90 mmHg

Exclusion Criteria

• primary hypertension
• diabetes
• allergy or sensitivity to any foods to be used in the study
• gastrointestinal disorders
• chronic kidney disease
• liver disease
• hepatitis
• estrogen-sensitive cancer
• heavy alcohol use
• sleep apnea
• bleeding disorders
• planned surgery (within time frame of study)
• angina
• Congestive Heart Failure
• coronary revascularization
• peripheral vascular disease and/or coronary/cerebrovascular events within the previous 6 months
• positive HIV diagnosis
• prescription of anti-depressants, anti-hypertensives, anti-coagulant medications, diuretics, sympathomimetics, herbal therapies, vitamin or K supplementation, medication affecting NO synthesis
• chronic use or prescription of NSAIDs
• women of childbearing potential must not be pregnant or breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Low-GI, High-GL Meal	Boiled Pasta	Boiled Pasta
Low-GI, High GL Meal	Boiled Chickpeas with Oil	Boiled Chickpeas with Oil
High-GI, High-GL Meal	Instant Mashed Potatoes	Instant Mashed Potatoes
High-GI, Low-GL Meal	Instant Mashed Potatoes with Egg Whites	Instant Mashed Potatoes with Egg Whites

Primary Outcome Measures

Name	Time	Method
To measure postprandial changes in augmentation index (AIx) to determine the acute effect of high- and low-GI and high- and low-GL meals on arterial stiffness.	4 separate mornings, measurements taken at baseline and at 60, 120, 180 and 240 minutes

Secondary Outcome Measures

Name	Time	Method
To determine the acute effect of high- and low-GI and high- and low- GL meals on central and peripheral blood pressure	4 separate mornings, measurements taken at baseline, 60, 120, 180 and 240 minutes.

Trial Locations

Locations (1)

Risk Factor Modification Centre, St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada