HealthyPhase 2HILONCT01883700
Acute Vascular Response To Meals Varying In Glycemic Index And Glycemic Load
A Phase 2 study testing Boiled Pasta, Boiled Chickpeas with Oil and Instant Mashed Potatoes in people with Healthy, run by Unity Health Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Boiled Pasta, Boiled Chickpeas with Oil and Instant Mashed Potatoes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2010to Sep 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy
- age 18 - 75 years
- BMI 18 - 25 kg/m2
- brachial systolic blood pressure < 140 mmHg
- brachial diastolic blood pressure < 90 mmHg
Who cannot join
- primary hypertension
- diabetes
- allergy or sensitivity to any foods to be used in the study
- gastrointestinal disorders
- chronic kidney disease
- liver disease
Show all 20Show fewer
- 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 locations and contacts
1 site in 1 country.
Canada1 site
Risk Factor Modification Centre, St. Michael's Hospital
Toronto, Ontario, M5B 1W8
About this study
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
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.
- Conditions
- Healthy
- Being tested
- Boiled Pasta, Boiled Chickpeas with Oil, Instant Mashed Potatoes, Instant Mashed Potatoes with Egg Whites
- Keywords
- Healthy, Glycemic Index, Glycemic Load, Blood Glucose, Arterial Stiffness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boiled PastaOther
Also called Italpasta Fusilli
Boiled Chickpeas with OilOther
Also called Irresistibles Life Smart Chick Peas
Instant Mashed PotatoesOther
Also called Betty Crocker Mashed Potatoes Homestyle
Instant Mashed Potatoes with Egg WhitesOther
Also called Betty Crocker Mashed Potatoes Homestyle, Naturegg Simply Egg Whites 100% Pure Liquid Egg Whites
| Study group | Role | What they receive |
|---|---|---|
| Low-GI, High-GL Meal | Experimental | Boiled Pasta Receives: Other: Boiled Pasta |
| Low-GI, High GL Meal | Experimental | Boiled Chickpeas with Oil Receives: Other: Boiled Chickpeas with Oil |
| High-GI, High-GL Meal | Experimental | Instant Mashed Potatoes Receives: Other: Instant Mashed Potatoes |
| High-GI, Low-GL Meal | Experimental | Instant Mashed Potatoes with Egg Whites Receives: Other: Instant Mashed Potatoes with Egg Whites |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 4 separate mornings, measurements taken at baseline, 60, 120, 180 and 240 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startAug 2010
- Primary completionSep 2011
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandra Jenkins, PhD, RD, Principal investigator, Unity Health TorontoVladimir Vuksan (Co-Investigator), PhD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01883700
- Sponsor's protocol ID
- 10-028
- Acronym
- HILO
- Status last verified
- Jun 2013
- First submitted
- 22 Feb 2013
- Last updated
- 21 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01883700
- Acronym / sponsor ID
- HILO / 10-028
- Conditions
- Healthy
- Keywords
- Healthy, Glycemic Index, Glycemic Load, Blood Glucose, Arterial Stiffness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2013 (estimated)
- First posted
- 21 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low-GI, High-GL Meal | Experimental | Other: Boiled PastaBoiled Pasta |
| Low-GI, High GL Meal | Experimental | Other: Boiled Chickpeas with OilBoiled Chickpeas with Oil |
| High-GI, High-GL Meal | Experimental | Other: Instant Mashed PotatoesInstant Mashed Potatoes |
| High-GI, Low-GL Meal | Experimental | Other: Instant Mashed Potatoes with Egg WhitesInstant Mashed Potatoes with Egg Whites |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- healthy
- age 18 - 75 years
- BMI 18 - 25 kg/m2
- brachial systolic blood pressure < 140 mmHg
- brachial diastolic blood pressure < 90 mmHg
Key exclusion criteria (20 listed)
- primary hypertension
- diabetes
- allergy or sensitivity to any foods to be used in the study
- gastrointestinal disorders
- chronic kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Boiled PastaAlso: Italpasta Fusilli | Other | Low-GI, High-GL Meal |
| Boiled Chickpeas with OilAlso: Irresistibles Life Smart Chick Peas | Other | Low-GI, High GL Meal |
| Instant Mashed PotatoesAlso: Betty Crocker Mashed Potatoes Homestyle | Other | High-GI, High-GL Meal |
| Instant Mashed Potatoes with Egg WhitesAlso: Betty Crocker Mashed Potatoes Homestyle, Naturegg Simply Egg Whites 100% Pure Liquid Egg Whites | Other | High-GI, Low-GL Meal |
Primary outcome
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
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra Jenkins, PhD, RD principal investigator
Unity Health Toronto
Vladimir Vuksan (Co-Investigator), PhD principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Boiled Pasta, Boiled Chickpeas with Oil and Instant Mashed Potatoes in people with Healthy, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 4 separate mornings, measurements taken at baseline and at 60, 120, 180 and 240 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2013.