Exercise-induced Changes in DNA-methylation

May 16, 2019 updated by: Norwegian University of Science and Technology

The Effect of Exercise on Maximal Aerobic Capacity, DNA-methylation and Gene Expression in Healthy Elderly Men

The purpose of the study was to investigate whether regular moderate- or high-intensity interval training can change the DNA methylation in a long-lasting state, and whether these changes affect the gene expression. In addition, the investigators will determine whether the intensity of the training could be an affecting factor of the possible DNA-methylation change as well. The null hypothesis was that no such exercise-induced changes occur.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway
        • Institute for Circulation and Medical Imaging, NTNU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years to 75 years (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male
  • 70-75 years old
  • Signed written informed consent

Exclusion Criteria:

  • Incompatible with exercise
  • Known cardiac disease
  • Active cancer
  • Significant pulmonary disease
  • Uncontrolled hypertension
  • Use of blood thinning medicine (except Albyl-E)
  • Drug abuse
  • Alcohol abuse
  • Finishing less than 80% of the exercise sessions (this complies to the training groups)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High-intensity interval training
The High-intensity interval training group was instructed to complete exercise sessions of 4x4-minutes intervals at 85-95% of maximal heart rate, 3 times a week for 8 weeks. This type of exercise include 10 minutes warm-up, followed by four intervals of four minutes high-intensity (85-95% of HRmax), with three minutes active breaks (70% of HRmax) between each interval, and ending with seven minutes cool-down. An exercise session last for 42 minutes, where the participants should breathe heavily and feel exhausted four times.
Behavioral: High-intensity interval training
Interval training 3 times a week for 8 weeks
Active Comparator: Moderate training
The moderate training group was instructed to complete exercise sessions of 50 minutes at 70% of maximal heart rate, 3 times a week for 8 weeks.
Behavioral: Moderate training
Moderate training 3 times a week for 8 weeks
No Intervention: Control
The control group followed the baseline and follow-up tests, and was asked to live normally and not change their dietary pattern or exercise habits during their participation in this project. Based on the well-known beneficial effects of exercise on general health, it was regarded unethical to demand the control group to desist from any types of physical activity during the project period. They got no further follow-up on exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DNA-methylation
Time Frame: 8 weeks
From the skeletal muscle biopsies RNA and DNA was isolated, DNA was further bi-sulfite converted and DNA-methylation was analyzed using the Illumina HumanMethylation450 BeadChip. The RNA was further used for gene expression analyses by real-time RTqPCR.
8 weeks
Gene Expression
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal Aerobic Capacity
Time Frame: 8 weeks
measured on treadmill at baseline and after eight weeks, also biopsies from Vastus lateralis were sampled.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

St. Olavs Hospital

Investigators

  • Study Director: Ulrik Wisløff, Professor, National Taiwan Normal University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

August 26, 2013

First Submitted That Met QC Criteria

August 28, 2013

First Posted (Estimate)

August 29, 2013

Study Record Updates

Last Update Posted (Actual)

May 20, 2019

Last Update Submitted That Met QC Criteria

May 16, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EPI-GEN100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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