DNA Methylation and Cancer Prevention: Duration and Intensity of Exercise (GEM)

July 27, 2023 updated by: Angela Bryan, University of Colorado, Boulder

Specific aim 1. Using a fully crossed 2 (intensity) X 2 (duration) design, the investigators will demonstrate a dose-response relationship between volume of aerobic exercise and changes in DNA methylation over four months among previously sedentary women.

Specific aim 2. There are no published data on the extent to which positive effects of exercise on methylation might decay if exercise is not continued. The investigators will gather data on the natural history of methylation decay after training.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Specific aim 1. Using a fully crossed 2 (intensity) X 2 (duration) design, the investigators will demonstrate a dose-response relationship between volume of aerobic exercise and changes in DNA methylation over four months among previously sedentary women.

  • Hypothesis 1: The investigators predict that there will be an interaction between intensity and duration characterized by a dose-dependent response to total exercise volume, such that women will experience the greatest improvements in methylation at high intensity/high duration (16.4 kcal/kg/week) and the least improvements in methylation at low intensity/low duration (5.6 kcal/kg/week).
  • Hypothesis 2: The investigators predict that there will be a main effect of exercise duration, such that women exercising for 40 minutes/session, 4 sessions per week will show more improvement in DNA methylation compared with women exercising for 20 minutes/session, 4 sessions per week.
  • Hypothesis 3: The investigators predict that there will be a main effect of exercise intensity, such that women exercising at 75% of VO2max will show more improvement in DNA methylation compared with women exercising at 55% of VO2max.

Specific aim 2. There are no published data on the extent to which positive effects of exercise on methylation might decay if exercise is not continued. The investigators will gather data on the natural history of methylation decay after training.

• Hypothesis 4: At six months following the end of supervised exercise, the investigators will assess the influence of the different levels of initial training and the passage of time on DNA methylation, covarying whether or not participants continued to exercise. It is predicted that the highest volume group will show the greatest persistence of positive changes in DNA methylation. Alternatively, it is possible that all four groups will return to baseline methylation levels of methylation, and there will be no difference in methylation at 6 months following the end of supervised exercise.

Study Type

Interventional

Enrollment (Actual)

276

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

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Image Lab/ University of Colorado Denver

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

30 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Female
  • Age 30-45
  • Sedentary (i.e., < 40 minutes per week of moderate physical activity in the past 6-months; this criterion will be relaxed to <60 minutes per week if it limits enrollment)
  • Menstruating regularly (not amenorrheic or dysmenorrheic)
  • Non-smokers
  • Willing to accept random assignment to condition
  • Willing to provide blood and saliva samples for epigenetic analysis
  • Willing to and physically capable of safely engaging in moderate exercise activity (i.e., no injuries, physical impairments, or pre-existing contraindications) as assessed by a study physician
  • Able to successfully complete a VO2max test without evidence of cardiac or other abnormalities
  • Planning to remain in the Denver metro area for the next 10 months

Exclusion Criteria:

  • Have a BMI > 35kg/m2
  • Are diabetic or on a restricted diet
  • Have uncontrolled hypertension defined as resting systolic BP >150 mmHg or diastolic BP>90 mmHg (to be assessed during physical exam, not on phone screen). (Participants who do not meet these criteria at first screening will be re-evaluated, including after follow-up evaluation by the primary care physician with initiation or adjustment of anti-hypertensive medications)
  • Have a cardiovascular or respiratory disease including subjective or objective indicators of ischemic heart disease (e.g., angina, ST segment depression) or serious arrhythmias at rest or during the maximal exercise test (VO2max). (Participants who do not meet these criteria at first screening will be re-evaluated; follow-up evaluation must include diagnostic testing (e.g., thallium stress test) with interpretation by a cardiologist)
  • Have a history of breast neoplasia
  • Are currently receiving treatment for any type of cancer
  • Are on psychotropic medications
  • Are currently under treatment for any psychiatric disorder
  • Are currently under treatment for alcohol or drug abuse
  • Are currently pregnant or attempting to become pregnant in the next 6-months

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High Intensity/Longer Duration
Exercise at higher intensity (~75% of VO2max) for 40 minute bouts 4 times per week
Behavioral: Exercise
The investigators will measure changes in DNA methylation as a result of four different intervention groups, i.e, high/longer, low/longer, high/shorter, low/shorter.
Other Names:
  • GEM
Experimental: High Intensity/Lower Duration
Exercise at high intensity (~75% of VO2max) for 20 minute bouts 4 times per week
Behavioral: Exercise
The investigators will measure changes in DNA methylation as a result of four different intervention groups, i.e, high/longer, low/longer, high/shorter, low/shorter.
Other Names:
  • GEM
Experimental: Lower Intensity/Higher Duration
Exercise at lower intensity (~55% of VO2max) for 40 minute bouts 4 times per week
Behavioral: Exercise
The investigators will measure changes in DNA methylation as a result of four different intervention groups, i.e, high/longer, low/longer, high/shorter, low/shorter.
Other Names:
  • GEM
Experimental: Low Intensity/Low Duration
Exercise at lower intensity (~55% of VO2max) for 20 minute bouts 4 times per week
Behavioral: Exercise
The investigators will measure changes in DNA methylation as a result of four different intervention groups, i.e, high/longer, low/longer, high/shorter, low/shorter.
Other Names:
  • GEM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
DNA METHYLATION
Time Frame: 4 months post-exercise initiation and 6 months after the end of the exercise intervention
4 months post-exercise initiation and 6 months after the end of the exercise intervention

Collaborators and Investigators

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

Sponsor

University of Colorado, Boulder

Collaborators

National Cancer Institute (NCI)
National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Angela Bryan, PhD, University of Colorado, Boulder
  • Principal Investigator: Wendy kohrt, PhD, UColoradoDenver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2014

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

December 16, 2013

First Submitted That Met QC Criteria

January 8, 2014

First Posted (Estimated)

January 10, 2014

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 27, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PQA-5
  • 1R01CA179963-01 (U.S. NIH Grant/Contract)

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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