NCT01067911

Brief Summary

Scientists believe that what happens to dietary fats after they are eaten, especially how they cleared from the blood, affects risks of heart disease and diabetes is more important than measuring blood fats after an overnight fast. Little is known about what happens in the 6-8 hours after eating common oils available in Canada such as soybean, canola, olive, sunflower or flax oils. Vegetable oils have different types of fatty acids. This study will gather information on what happens to these fatty acids after they are eaten in a meal. The purpose of this research is to show that clearance of fat from the blood varies with the type of vegetable oil in a meal.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 12, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

June 1, 2016

Status Verified

May 1, 2016

Enrollment Period

3.5 years

First QC Date

February 10, 2010

Last Update Submit

May 31, 2016

Conditions

Keywords

Postprandial lipidstest mealfatty acids

Outcome Measures

Primary Outcomes (1)

  • Outcome Plasma triglyceride and fatty acids after eating an oil or fat

    8 hours

Study Arms (4)

1

ACTIVE COMPARATOR

In this study subjects will consume test meals containing vegetable oils (soy) and butter

Dietary Supplement: Butter and Vegetable oils from soy, flaxseed, high oleic safflower and canola

2

ACTIVE COMPARATOR

In this study subjects will consume test meals containing vegetable oils (flaxseed) and butter

Dietary Supplement: In this study subjects will consume test meals containing vegetable oils (soy, flaxseed, high oleic safflower and canola) and butter

3

ACTIVE COMPARATOR

In this study subjects will consume test meals containing vegetable oils (high oleic safflower) and butter

Dietary Supplement: In this study subjects will consume test meals containing vegetable oils (soy, flaxseed, high oleic safflower and canola) and butter

4

ACTIVE COMPARATOR

In this study subjects will consume test meals containing vegetable oils (canola) and butter

Dietary Supplement: In this study subjects will consume test meals containing vegetable oils (soy, flaxseed, high oleic safflower and canola) and butter

Interventions

Test meals prepared with different common fats and oils and consumed by test subjects. Postprandial lipids will be assessed for 6 hours after the consumption of the test meal.

1

Test meals prepared with different common fats and oils and consumed by test subjects. Postprandial lipids will be assessed for 6 hours after the consumption of the test meal.

2

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Non-smoking, with BMI \> 19 \< 28 kg/m2
  • Waist circumference \< 102 cm (40 in) for men and \< 88 cm (35 in) for women
  • No known chronic disease such as diabetes, heart or thyroid disease or disorder of fat metabolism
  • Not taking OTC or prescription medications, not following a vegan or vegetarian diet, not taking fish oil
  • Willing to avoid some high fat foods and alcohol for two days, then eat a standardized meal with collection of blood samples over the following 8 hours

You may not qualify if:

  • No elite athletes or those engaged in vigorous physical activity
  • Smokers or those with BMI \> 28 or \<19
  • Waist circumference \> 102 cm for men and 88 cm for women
  • Known chronic disease such as diabetes or disease involving fat metabolism, the heart or thyroid will be excluded from the study
  • Subjects who take any routine prescribed or over-the-counter medications, fatty acids, antioxidant or fish oil, those following a vegan or vegetarian diet, and those who are not willing to abstain from alcoholic beverages and high fat foods for 2 days prior to the test meal and not willing to eat a standardized meal and provide blood samples over the following 8 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Child & Family Research Institute, BC Children's Hospital

Vancouver, British Columbia, Canada

Location

MeSH Terms

Interventions

ButterLinseed Oil

Intervention Hierarchy (Ancestors)

Dietary FatsFatsLipidsDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesFats, UnsaturatedPlant OilsOilsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Sheila M. Innis, Dr.

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2010

First Posted

February 12, 2010

Study Start

July 1, 2009

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

June 1, 2016

Record last verified: 2016-05

Locations