NCT01233778

Brief Summary

The objectives of this study are to examine how the consumption of treatment oils (including canola oil, DHA enriched canola-oil, high oleic acid canola oil, flax oil, and safflower oil) influence endothelial function, inflammation, oxidation, body composition, and plasma lipoprotein characterization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 1, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 3, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

August 21, 2023

Status Verified

August 1, 2023

Enrollment Period

1.4 years

First QC Date

November 1, 2010

Last Update Submit

August 16, 2023

Conditions

Cardiovascular Disease

Keywords

Cardiovascular diseaseOmega-3 fatty acidsInflammationEndothelial functionCanola oil

Outcome Measures

Primary Outcomes (5)

  • Endothelial Health

    Study subjects will undergo endothelial health assessment by EndoPAT analysis. The EndoPat procedure will occur while the subject is lying down in a relaxed state. Throughout the study, the inflation pressure of the EndoPAT device will be electronically set to 10mm Hg below diastolic BP. Testing begins with 10 min of rest. Following rest, baseline pulse amplitude is measured from each fingertip for 5 min. Next, arterial flow is interrupted for 5 min by a cuff placed on the forearm at an occlusion pressure of 250 mmHg. Following occlusion release, pulse amplitude recording continues for 5 min.

    End of diet period 1 (week 4)

  • Endothelial Health

    Study subjects will undergo endothelial health assessment by EndoPAT analysis. The EndoPat procedure will occur while the subject is lying down in a relaxed state. Throughout the study, the inflation pressure of the EndoPAT device will be electronically set to 10mm Hg below diastolic BP. Testing begins with 10 min of rest. Following rest, baseline pulse amplitude is measured from each fingertip for 5 min. Next, arterial flow is interrupted for 5 min by a cuff placed on the forearm at an occlusion pressure of 250 mmHg. Following occlusion release, pulse amplitude recording continues for 5 min.

    End of diet period 2 (week 12)

  • Endothelial Health

    Study subjects will undergo endothelial health assessment by EndoPAT analysis. The EndoPat procedure will occur while the subject is lying down in a relaxed state. Throughout the study, the inflation pressure of the EndoPAT device will be electronically set to 10mm Hg below diastolic BP. Testing begins with 10 min of rest. Following rest, baseline pulse amplitude is measured from each fingertip for 5 min. Next, arterial flow is interrupted for 5 min by a cuff placed on the forearm at an occlusion pressure of 250 mmHg. Following occlusion release, pulse amplitude recording continues for 5 min.

    End of diet period 3 (week 20)

  • Endothelial Health

    Study subjects will undergo endothelial health assessment by EndoPAT analysis. The EndoPat procedure will occur while the subject is lying down in a relaxed state. Throughout the study, the inflation pressure of the EndoPAT device will be electronically set to 10mm Hg below diastolic BP. Testing begins with 10 min of rest. Following rest, baseline pulse amplitude is measured from each fingertip for 5 min. Next, arterial flow is interrupted for 5 min by a cuff placed on the forearm at an occlusion pressure of 250 mmHg. Following occlusion release, pulse amplitude recording continues for 5 min.

    End of diet period 4 (week 28)

  • Endothelial Health

    Study subjects will undergo endothelial health assessment by EndoPAT analysis. The EndoPat procedure will occur while the subject is lying down in a relaxed state. Throughout the study, the inflation pressure of the EndoPAT device will be electronically set to 10mm Hg below diastolic BP. Testing begins with 10 min of rest. Following rest, baseline pulse amplitude is measured from each fingertip for 5 min. Next, arterial flow is interrupted for 5 min by a cuff placed on the forearm at an occlusion pressure of 250 mmHg. Following occlusion release, pulse amplitude recording continues for 5 min.

    End of diet period 5 (week 36)

Secondary Outcomes (4)

  • Body Composition

    Week 4, 12, 20, 28 and 36 - End of each diet period

  • Production of long chain fatty acids

    Week 4, 12, 20, 28 and 36 - End of each diet period

  • Plasma Lipids

    Week 4, 12, 20, 28 and 36 - End of each diet period

  • Plasma Cytokines

    Week 4, 12, 20, 28 and 36 - End of each diet period

Study Arms (5)

Canola Oil

EXPERIMENTAL
Dietary Supplement: Canola Oil

High Oleic Acid Canola + DHA

EXPERIMENTAL
Dietary Supplement: High Oleic Acid + DHA Canola Oil

High Oleic Canola Oil

EXPERIMENTAL
Dietary Supplement: High Oleic Acid Canola Oil

Flax & Safflower Oil (60:40)

EXPERIMENTAL
Dietary Supplement: Flax Oil

Safflower & Corn Oil (75:25)

EXPERIMENTAL
Dietary Supplement: Safflower Oil

Interventions

Canola OilDIETARY_SUPPLEMENT

60g Canola oil daily per 3000kcal diet provided in a supplemental shake

Canola Oil
High Oleic Acid + DHA Canola OilDIETARY_SUPPLEMENT

60g high oleic acid canola oil + DHA daily per 3000kcal provided in a supplemental shake

High Oleic Acid Canola + DHA
High Oleic Acid Canola OilDIETARY_SUPPLEMENT

60g high oleic acid canola oil daily per 3000kcal provided in a supplemental shake

High Oleic Canola Oil
Flax OilDIETARY_SUPPLEMENT

36g flax oil + 24g safflower oil daily per 3000kcal provided in a supplemental shake

Flax & Safflower Oil (60:40)
Safflower OilDIETARY_SUPPLEMENT

45g safflower oil + 15g corn oil daily per 3000kcal provided in a supplemental shake

Safflower & Corn Oil (75:25)

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 20-65 years
  • BMI = 22-32 kg/m2
  • In addition, eligibility will be based on metabolic syndrome criteria where we define eligibility on the basis of subjects having elevated waist circumference + 1 or more of the remaining 5 criteria:
  • Elevated waist circumference - \> 102 cm for men and \>88 cm for women
  • Elevated triglycerides - ≥ 1.7 mmol/L ( ≥150mg/dl) ( no upper limit)
  • Reduced HDL - \< 1 mmol/L (\<40 mg/dl) for men and \< 1.3 mmol/L (\<50 mg/dl)for women
  • Fasting glucose - ≥ 100 mg/dl (no upper limit)
  • Elevated blood pressure - systolic ≥130 and/or diastolic ≥85 mm HG
  • Unmedicated participants - upper limit of Stage 1 Hypertension: systolic ≤ 159 and/or diastolic ≤ 99 mm HG and participants must be free of end stage/target organ disease symptoms
  • BP medicated participants: acceptable as long as individuals meet the specified blood pressure range of \<140/90 mmHg, and have been stable for at least 6 months.

You may not qualify if:

  • Smokers\*\*
  • History of thyroid disease, diabetes, kidney or liver disease, heart disease, or other chronic diseases
  • Heavy alcohol consumption (\>14 drinks/week)
  • Chronic anti-inflammatory medication use
  • Lactation, pregnancy, or desire to become pregnant during the study
  • Taking lipid lowering medications (cholestyramine, colestipol, niacin, clofibrate, gemfibrozil probucol, HMG CoA reductase inhibitors) within the last three months
  • Not willing to refrain from blood/plasma donation during the study period
  • Gall bladder removal
  • For purposes of the this study non-smoking is defined as \>6 months smoke-free; there is some evidence to show that smoking cessation increases HDL levels and 6 months is adequate time for this to stabilize, however this time span was chosen based on the decreased rate of relapse after 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State University

University Park, Pennsylvania, 16802, United States

Location

MeSH Terms

Conditions

Cardiovascular DiseasesInflammation

Interventions

Rapeseed OilLinseed OilSafflower Oil

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant OilsOilsLipidsPlant PreparationsBiological ProductsComplex MixturesFats, UnsaturatedFatsDietary Fats, UnsaturatedDietary FatsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Penny M Kris-Etherton, PhD, RD

    Penn State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2010

First Posted

November 3, 2010

Study Start

October 1, 2010

Primary Completion

March 1, 2012

Study Completion

April 1, 2012

Last Updated

August 21, 2023

Record last verified: 2023-08

Locations

US(1)