Trial record 3 of 218 for:    Open Studies | dietary fats

Comparison of Dietary Fats on Vascular Parameters (COIL)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by St. Michael's Hospital, Toronto
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT01876394
First received: June 9, 2013
Last updated: March 7, 2014
Last verified: December 2013
  Purpose

The purpose of the study is to examine the effect of consuming 50g of fat from 5 different sources (coconut, canola, walnut, chia, and butter) on arterial stiffness, blood pressure and blood glucose levels. It is hypothesized that butter will have the most detrimental effect on acute vascular function. Canola, walnut and chia oil with their decreased content of SFA are hypothesized to impair vascular function to a lesser extent.


Condition Intervention
Healthy
Other: Coconut Oil
Other: Canola Oil
Other: Walnut Oil
Other: Chia Oil
Other: Butter

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: Acute Effects of Dietary Fats on Postprandial Vascular Function in Healthy Individuals: Pilot Double Blind, Randomized, Controlled Trial

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • To compare 5 different dietary fat sources in a liquid meal on postprandial changes in augmentation index (AIx) [ Time Frame: 5 separate mornings, measurements taken at baseline and at 60, 120 and 180 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To investigate whether these dietary fat sources will result in blood pressure changes and a differential glycemic response [ Time Frame: 5 separate mornings, blood pressure measurements will be taken at baseline, 60, 120 and 180 minutes. Blood samples will be taken at baseline 15, 30, 45, 60, 90 and 120 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: June 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Coconut oil Other: Coconut Oil
Shake with 50 g Coconut oil
Other: Canola Oil
Shake with 50 g Canola oil
Other: Walnut Oil
Shake with 50 g Walnut oil
Other: Chia Oil
Shake with 50 g Chia oil
Other: Butter
Shake with 50 g Butter
Experimental: Canola oil Other: Coconut Oil
Shake with 50 g Coconut oil
Other: Canola Oil
Shake with 50 g Canola oil
Other: Walnut Oil
Shake with 50 g Walnut oil
Other: Chia Oil
Shake with 50 g Chia oil
Other: Butter
Shake with 50 g Butter
Experimental: Walnut oil Other: Coconut Oil
Shake with 50 g Coconut oil
Other: Canola Oil
Shake with 50 g Canola oil
Other: Walnut Oil
Shake with 50 g Walnut oil
Other: Chia Oil
Shake with 50 g Chia oil
Other: Butter
Shake with 50 g Butter
Experimental: Chia oil Other: Coconut Oil
Shake with 50 g Coconut oil
Other: Canola Oil
Shake with 50 g Canola oil
Other: Walnut Oil
Shake with 50 g Walnut oil
Other: Chia Oil
Shake with 50 g Chia oil
Other: Butter
Shake with 50 g Butter
Placebo Comparator: Butter Other: Coconut Oil
Shake with 50 g Coconut oil
Other: Canola Oil
Shake with 50 g Canola oil
Other: Walnut Oil
Shake with 50 g Walnut oil
Other: Chia Oil
Shake with 50 g Chia oil
Other: Butter
Shake with 50 g Butter

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy
  • Age 18-65 years
  • BMI < 30 kg/m2
  • Brachial systolic blood pressure ≤ 140 mmHg
  • Brachial diastolic blood pressure ≤ 90 mmHg

Exclusion Criteria:

  • Women of childbearing age must not be pregnant or breastfeeding at the time of the study
  • BMI >35kg/m2
  • Hypertensive as defined by brachial SBP >140mmHg and/or DBP >90mmHg
  • Sensitivity to the study product or its sources
  • Presence of chronic conditions or illnesses
  • Having any gastrointestinal complication or condition
  • Chronic use of dietary supplements that alter fat absorption
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01876394

Contacts
Contact: Thanh Ho, BSc 416-864-6060 ext 2087 hoho@smh.ca

Locations
Canada, Ontario
Risk Factor Modification Centre, St. Michael's Hospital Not yet recruiting
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
Principal Investigator: Vuksan Vladimir, PhD Risk Factor Modification Centre - St. Michael's Hospital
Principal Investigator: Alexandra Jenkins (Co-investigator), PhD, RD St. Michael's Hospital, Toronto
Principal Investigator: William Watson (Qualified investigator), MD St. Michael's Hospital, Toronto
Principal Investigator: Elena Jovanovski (Co-investigator), MSc St. Michael's Hospital, Toronto
  More Information

No publications provided

Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT01876394     History of Changes
Other Study ID Numbers: COIL
Study First Received: June 9, 2013
Last Updated: March 7, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by St. Michael's Hospital, Toronto:
Healthy
Arterial Stiffness
Blood Pressure
Blood Glucose
Vascular Function

ClinicalTrials.gov processed this record on July 20, 2014