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

U

Unity Health Toronto

Status and phase

Unknown
Phase 2

Conditions

Healthy

Treatments

Other: Instant Mashed Potatoes
Other: Instant Mashed Potatoes with Egg Whites
Other: Boiled Chickpeas with Oil
Other: Boiled Pasta

Study type

Interventional

Funder types

Other

Identifiers

NCT01883700
10-028

Details and patient eligibility

About

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.

Enrollment

21 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

21 participants in 4 patient groups

Low-GI, High-GL Meal
Experimental group
Description:
Boiled Pasta
Treatment:
Other: Boiled Pasta
Low-GI, High GL Meal
Experimental group
Description:
Boiled Chickpeas with Oil
Treatment:
Other: Boiled Chickpeas with Oil
High-GI, High-GL Meal
Experimental group
Description:
Instant Mashed Potatoes
Treatment:
Other: Instant Mashed Potatoes
High-GI, Low-GL Meal
Experimental group
Description:
Instant Mashed Potatoes with Egg Whites
Treatment:
Other: Instant Mashed Potatoes with Egg Whites

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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