This trial is active, not recruiting.

Condition healthy
Treatments boiled pasta, boiled chickpeas with oil, instant mashed potatoes, instant mashed potatoes with egg whites
Phase phase 2
Sponsor St. Michael's Hospital, Toronto
Start date August 2010
End date September 2011
Trial size 21 participants
Trial identifier NCT01883700, 10-028


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose prevention
Boiled Pasta
boiled pasta Italpasta Fusilli
Boiled Chickpeas with Oil
boiled chickpeas with oil Irresistibles Life Smart Chick Peas
Instant Mashed Potatoes
instant mashed potatoes Betty Crocker Mashed Potatoes Homestyle
Instant Mashed Potatoes with Egg Whites
instant mashed potatoes with egg whites Betty Crocker Mashed Potatoes Homestyle

Primary Outcomes

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.
time frame: 4 separate mornings, measurements taken at baseline and at 60, 120, 180 and 240 minutes

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title 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
Principal investigator Alexandra Jenkins, PhD, RD
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by St. Michael's Hospital, Toronto.