Acute Vascular Response To Meals Varying In Glycemic Index And Glycemic Load (HILO)

Variability of Acute Response to Equicaloric Test Meals Varying in Glycemic Index and Glycemic Load on Postprandial Glycemia, Arterial Stiffness and Blood Pressure in Healthy Adults

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.

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Other: Boiled Pasta; Other: Boiled Chickpeas with Oil; Other: Instant Mashed Potatoes; Other: Instant Mashed Potatoes with Egg Whites

• Study Type: Interventional
• Enrollment (Anticipated): 21
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B 1W8
      • Risk Factor Modification Centre, St. Michael's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Low-GI, High-GL Meal; Boiled Pasta	Other: Boiled Pasta; Other Names: Italpasta Fusilli
EXPERIMENTAL: Low-GI, High GL Meal; Boiled Chickpeas with Oil	Other: Boiled Chickpeas with Oil; Other Names: Irresistibles Life Smart Chick Peas
EXPERIMENTAL: High-GI, High-GL Meal; Instant Mashed Potatoes	Other: Instant Mashed Potatoes; Other Names: Betty Crocker Mashed Potatoes Homestyle
EXPERIMENTAL: High-GI, Low-GL Meal; Instant Mashed Potatoes with Egg Whites	Other: Instant Mashed Potatoes with Egg Whites; Other Names: Betty Crocker Mashed Potatoes Homestyle; Naturegg Simply Egg Whites 100% Pure Liquid Egg Whites

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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.

Other Outcome Measures

Outcome Measure	Time Frame
To determine whether the effects of high- and low-GI and high- and low-GL meals on postprandial glycemia are correlation with arterial stiffness, central and peripheral blood pressure.	4 separate mornings, measurements taken at baseline 15, 30, 45, 60, 90, 120, 180 and 240 minutes

Collaborators and Investigators

• Sponsor: Unity Health Toronto
• Investigators: Principal Investigator: Alexandra Jenkins, PhD, RD, Unity Health Toronto; Principal Investigator: Vladimir Vuksan (Co-Investigator), PhD, Unity Health Toronto

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (ACTUAL): September 1, 2011
• Study Completion (ANTICIPATED): September 1, 2013

Study Registration Dates

• First Submitted: February 22, 2013
• First Submitted That Met QC Criteria: June 19, 2013
• First Posted (ESTIMATE): June 21, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): June 21, 2013
• Last Update Submitted That Met QC Criteria: June 19, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Healthy; Arterial Stiffness; Blood Glucose; Glycemic Index; Glycemic Load
• Other Study ID Numbers: 10-028