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Endothelial Dysfunction Induced by Postprandial Lipemia

Primary Purpose

Healthy Subjects

Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
exercise training
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy Subjects focused on measuring flow mediated dilatation, maximal oxygen uptake, blood lipid

Eligibility Criteria

20 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • male, 20-40years, BMI between 25 and 30, resident in Trondheim.

Exclusion Criteria:

  • unstable angina, CHD, heart failure,

Sites / Locations

  • NTNU

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

No Intervention

Experimental

Arm Label

1

2

3

Arm Description

Control

moderate exercise training group

high intensity exercise group

Outcomes

Primary Outcome Measures

Flow mediated dilatation

Secondary Outcome Measures

blood lipid profile

Full Information

First Posted
April 15, 2008
Last Updated
January 5, 2012
Sponsor
Norwegian University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT00660491
Brief Title
Endothelial Dysfunction Induced by Postprandial Lipemia
Official Title
Endothelial Dysfunction Induced by Postprandial Lipemia: Complete Protection Afforded by High Intensity Aerobic Interval Exercise
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Postprandial lipemia and exercise oppose each other in terms of cardiovascular risk, however the mechanism of their interaction is not well understood. Therefore we want to study vascular function, as assessed by brachial artery (BA) flow mediated dilation (FMD), in healthy men before and after a high fat meal (HFM) preceded (16-18 hrs) by rest, a single bout of continuous moderate intensity exercise (CME), and high intensity interval exercise (HIIE).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Subjects
Keywords
flow mediated dilatation, maximal oxygen uptake, blood lipid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
Control
Arm Title
2
Arm Type
No Intervention
Arm Description
moderate exercise training group
Arm Title
3
Arm Type
Experimental
Arm Description
high intensity exercise group
Intervention Type
Other
Intervention Name(s)
exercise training
Intervention Description
moderate intensity exercise group, and high intensity exercise group
Primary Outcome Measure Information:
Title
Flow mediated dilatation
Time Frame
baseline, post exercise, 30min, 2hour, 4hour post exercise
Secondary Outcome Measure Information:
Title
blood lipid profile
Time Frame
same as flow mediated dilatation

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: male, 20-40years, BMI between 25 and 30, resident in Trondheim. Exclusion Criteria: unstable angina, CHD, heart failure,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrik Wisloff, Professor
Organizational Affiliation
National Taiwan Normal University
Official's Role
Study Chair
Facility Information:
Facility Name
NTNU
City
Trondheim
ZIP/Postal Code
7489
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
19130989
Citation
Tyldum GA, Schjerve IE, Tjonna AE, Kirkeby-Garstad I, Stolen TO, Richardson RS, Wisloff U. Endothelial dysfunction induced by post-prandial lipemia: complete protection afforded by high-intensity aerobic interval exercise. J Am Coll Cardiol. 2009 Jan 13;53(2):200-6. doi: 10.1016/j.jacc.2008.09.033.
Results Reference
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Endothelial Dysfunction Induced by Postprandial Lipemia

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