NCT00660491

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2008

Shorter than P25 for phase_2

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

January 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

January 6, 2012

Status Verified

January 1, 2012

Enrollment Period

8 months

First QC Date

April 15, 2008

Last Update Submit

January 5, 2012

Conditions

Healthy Subjects

Keywords

flow mediated dilatationmaximal oxygen uptakeblood lipid

Outcome Measures

Primary Outcomes (1)

  • Flow mediated dilatation

    baseline, post exercise, 30min, 2hour, 4hour post exercise

Secondary Outcomes (1)

  • blood lipid profile

    same as flow mediated dilatation

Study Arms (3)

1

NO INTERVENTION

Control

2

NO INTERVENTION

moderate exercise training group

3

EXPERIMENTAL

high intensity exercise group

Other: exercise training

Interventions

exercise trainingOTHER

moderate intensity exercise group, and high intensity exercise group

3

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • unstable angina, CHD, heart failure,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NTNU

Trondheim, 7489, Norway

Location

Related Publications (1)

  • 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.

    PMID: 19130989RESULT

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ulrik Wisloff, Professor

    National Taiwan Normal University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2008

First Posted

April 17, 2008

Study Start

January 1, 2008

Primary Completion

September 1, 2008

Study Completion

October 1, 2008

Last Updated

January 6, 2012

Record last verified: 2012-01

Locations

NO(1)