Clinical trial NCT01883700: Acute Vascular Response To Meals Varying In Glycemic Index And Glycemic Load
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Healthy
Keywords: Healthy
Glycemic Index
Glycemic Load
Blood Glucose
Arterial Stiffness
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2013-06-21
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 4 separate mornings, measurements taken at baseline and at 60, 120, 180 and 240 minutes
Secondary outcomes:
measure: To determine the acute effect of high- and low-GI and high- and low- GL meals on central and peripheral blood pressure
timeFrame: 4 separate mornings, measurements taken at baseline, 60, 120, 180 and 240 minutes.
Other outcomes:
measure: 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.
timeFrame: 4 separate mornings, measurements taken at baseline 15, 30, 45, 60, 90, 120, 180 and 240 minutes
Locations:
city: Toronto
country: Canada
facility: Risk Factor Modification Centre, St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Alexandra Jenkins, PhD, RD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unity Health Toronto
name: Vladimir Vuksan (Co-Investigator), PhD
role: PRINCIPAL_INVESTIGATOR
References: