Ignite Creation Date:
2024-05-06 @ 2:23 AM
Last Modification Date:
2024-10-26 @ 11:17 AM
Study NCT ID:
NCT02032628
Status:
COMPLETED
Last Update Posted:
2023-08-01
First Post:
2013-12-16
Brief Title:
DNA Methylation and Cancer Prevention Duration and Intensity of Exercise
Sponsor:
University of Colorado Boulder
Organization:
University of Colorado Boulder
Study Overview
Official Title:
DNA Methylation and Cancer Prevention Duration and Intensity of Exercise
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GEM
Brief Summary:
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
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
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 intensityhigh duration 164 kcalkgweek and the least improvements in methylation at low intensitylow duration 56 kcalkgweek
Hypothesis 2 The investigators predict that there will be a main effect of exercise duration such that women exercising for 40 minutessession 4 sessions per week will show more improvement in DNA methylation compared with women exercising for 20 minutessession 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
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 intensityhigh duration 164 kcalkgweek and the least improvements in methylation at low intensitylow duration 56 kcalkgweek
Hypothesis 2 The investigators predict that there will be a main effect of exercise duration such that women exercising for 40 minutessession 4 sessions per week will show more improvement in DNA methylation compared with women exercising for 20 minutessession 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01CA179963-01 | NIH | None | httpsreporternihgovquickSearch1R01CA179963-01 |