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

Healthy Clinical Trial

— HILO  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01883700
• Other study ID #: 10-028
• Status: Active, not recruiting
• Phase: Phase 2
• First received: February 22, 2013
• Last updated: June 19, 2013
• Start date: August 2010
• Est. completion date: September 2013

Study information

• Verified date: June 2013
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 21
• Est. completion date: September 2013
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Boiled Pasta

• Boiled Chickpeas with Oil

• Instant Mashed Potatoes

• Instant Mashed Potatoes with Egg Whites

Locations

Country	Name	City	State
Canada	Risk Factor Modification Centre, St. Michael's Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Secondary	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.	No