NCT01883700

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
21

participants targeted

Target at below P25 for phase_2 healthy

Timeline
Completed

Started Aug 2010

Typical duration for phase_2 healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2013

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 21, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

June 21, 2013

Status Verified

June 1, 2013

Enrollment Period

1.1 years

First QC Date

February 22, 2013

Last Update Submit

June 19, 2013

Conditions

Healthy

Keywords

HealthyGlycemic IndexGlycemic LoadBlood GlucoseArterial Stiffness

Outcome Measures

Primary Outcomes (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.

    4 separate mornings, measurements taken at baseline and at 60, 120, 180 and 240 minutes

Secondary Outcomes (1)

  • 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.

Other Outcomes (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.

    4 separate mornings, measurements taken at baseline 15, 30, 45, 60, 90, 120, 180 and 240 minutes

Study Arms (4)

Low-GI, High-GL Meal

EXPERIMENTAL

Boiled Pasta

Other: Boiled Pasta

Low-GI, High GL Meal

EXPERIMENTAL

Boiled Chickpeas with Oil

Other: Boiled Chickpeas with Oil

High-GI, High-GL Meal

EXPERIMENTAL

Instant Mashed Potatoes

Other: Instant Mashed Potatoes

High-GI, Low-GL Meal

EXPERIMENTAL

Instant Mashed Potatoes with Egg Whites

Other: Instant Mashed Potatoes with Egg Whites

Interventions

Boiled PastaOTHER
Also known as: Italpasta Fusilli
Low-GI, High-GL Meal
Boiled Chickpeas with OilOTHER
Also known as: Irresistibles Life Smart Chick Peas
Low-GI, High GL Meal
Instant Mashed PotatoesOTHER
Also known as: Betty Crocker Mashed Potatoes Homestyle
High-GI, High-GL Meal
Instant Mashed Potatoes with Egg WhitesOTHER
Also known as: Betty Crocker Mashed Potatoes Homestyle, Naturegg Simply Egg Whites 100% Pure Liquid Egg Whites
High-GI, Low-GL Meal

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy
  • age 18 - 75 years
  • BMI 18 - 25 kg/m2
  • brachial systolic blood pressure \< 140 mmHg
  • brachial diastolic blood pressure \< 90 mmHg

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Risk Factor Modification Centre, St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

MeSH Terms

Interventions

OilsEgg White

Intervention Hierarchy (Ancestors)

LipidsEggsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Alexandra Jenkins, PhD, RD

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

  • Vladimir Vuksan (Co-Investigator), PhD

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2013

First Posted

June 21, 2013

Study Start

August 1, 2010

Primary Completion

September 1, 2011

Study Completion

September 1, 2013

Last Updated

June 21, 2013

Record last verified: 2013-06

Locations

CA(1)