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Trial record 59 of 747 for:    Area Under Curve AND meal

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

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ClinicalTrials.gov Identifier: NCT01883700
Recruitment Status : Unknown
Verified June 2013 by St. Michael's Hospital, Toronto.
Recruitment status was:  Active, not recruiting
First Posted : June 21, 2013
Last Update Posted : June 21, 2013
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, 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.

Condition or disease Intervention/treatment Phase
Healthy Other: Boiled Pasta Other: Boiled Chickpeas with Oil Other: Instant Mashed Potatoes Other: Instant Mashed Potatoes with Egg Whites Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : August 2010
Actual Primary Completion Date : September 2011
Estimated Study Completion Date : September 2013

Arm Intervention/treatment
Experimental: Low-GI, High-GL Meal
Boiled Pasta
Other: Boiled Pasta
Other Name: Italpasta Fusilli

Experimental: Low-GI, High GL Meal
Boiled Chickpeas with Oil
Other: Boiled Chickpeas with Oil
Other Name: Irresistibles Life Smart Chick Peas

Experimental: High-GI, High-GL Meal
Instant Mashed Potatoes
Other: Instant Mashed Potatoes
Other Name: 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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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. ]

Other Outcome Measures:
  1. 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. [ Time Frame: 4 separate mornings, measurements taken at baseline 15, 30, 45, 60, 90, 120, 180 and 240 minutes ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01883700


Locations
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Canada, Ontario
Risk Factor Modification Centre, St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
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Principal Investigator: Alexandra Jenkins, PhD, RD St. Michael's Hospital, Toronto
Principal Investigator: Vladimir Vuksan (Co-Investigator), PhD St. Michael's Hospital, Toronto

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Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT01883700     History of Changes
Other Study ID Numbers: 10-028
First Posted: June 21, 2013    Key Record Dates
Last Update Posted: June 21, 2013
Last Verified: June 2013
Keywords provided by St. Michael's Hospital, Toronto:
Healthy
Glycemic Index
Glycemic Load
Blood Glucose
Arterial Stiffness