Ignite Creation Date:
2024-07-17 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06471582
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-17
Brief Title:
Timing of Energy Availability on Menstrual Cycle Function
Sponsor:
University of Colorado Colorado Springs
Organization:
University of Colorado Colorado Springs
Study Overview
Official Title:
Implications for the Timing of Energy Availability on Menstrual Cycle Function
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
FAST
Brief Summary:
The primary aim of this clinical trial is to evaluate how fasted prolonged exercise may influence circulating reproductive hormones ie estradiol progesterone luteinizing hormone and menstrual cycle length when energy availability is maintained at or above 30 kcalkg lean body mass day among women who regularly do running or cycling exercise A secondary aim is to determine the effects of fasted prolonged exercise on serum leptin and cortisol
Participants will be asked to do the following over a 3 month enrollment period
attend a laboratory visit at the beginning of the study to have their resting metabolic rate aerobic fitness and body composition tested
monitor their menstrual cycle length urine hormones perceived stress levels and diet for 3 months
complete 3 90-minute exercise sessions on a stationary bike or treadmill either fed consuming a carbohydrate meal 1 h prior and 07 g carbohydrate kg body mass h during exercise or fasted consuming no meal prior and no carbohydrates during exercise during month 3
saliva samples will be taken prior to and after 90-minute exercise sessions for quantification of leptin and cortisol
Participants will be asked to do the following over a 3 month enrollment period
attend a laboratory visit at the beginning of the study to have their resting metabolic rate aerobic fitness and body composition tested
monitor their menstrual cycle length urine hormones perceived stress levels and diet for 3 months
complete 3 90-minute exercise sessions on a stationary bike or treadmill either fed consuming a carbohydrate meal 1 h prior and 07 g carbohydrate kg body mass h during exercise or fasted consuming no meal prior and no carbohydrates during exercise during month 3
saliva samples will be taken prior to and after 90-minute exercise sessions for quantification of leptin and cortisol
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None