Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06560944
Status:
COMPLETED
Last Update Posted:
None
First Post:
2023-06-27
Brief Title:
Oral Contraceptive Consumption Timing and Cognition and Metabolism
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Oral Contraceptive Consumption Timing on Cognition and Metabolism
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this randomised-controlled trial is to examine whether the timing of oral contraceptive administration affects cognitive function substrate metabolism and exercise performance
Participants will attend the laboratory for a familiarisation session followed by two main trials in which cognition and exercise metabolism and performance are measured In one trial they will be given their oral contraceptive 60 minutes before testing begins in the other they will be given a placebo Following testing 60 minutes participants will consume the alternative pill
Participants will attend the laboratory for a familiarisation session followed by two main trials in which cognition and exercise metabolism and performance are measured In one trial they will be given their oral contraceptive 60 minutes before testing begins in the other they will be given a placebo Following testing 60 minutes participants will consume the alternative pill
Detailed Description:
Reproductive hormones such as oestrogen and progesterone are known to affect cognitive function ie thinking learning and processing information and substrate metabolism ie how the body uses carbohydrates and fats Oral contraceptives contain synthetic versions of reproductive hormones and are used by approximately half of women of reproductive age When oral contraceptives are ingested the concentrations of these synthetic hormones spike in the blood for several hours yet no research has explored the effect of this spike on how the body works especially with regards to cognitive function and substrate metabolism If this spike in synthetic hormone concentrations affects cognition or metabolism this could influence the way in which women use oral contraceptives such as altering the timing of ingestion to improve performance and health outcomes
The proposed study will use participants that currently use a specific preparation of oral contraceptive 30micrograms ethinyl estradiol and 150mg Levonorgestrel and compare cognitive function and substrate metabolism on an occasion when a placebo is consumed lactose - no hormones to an occasion when their oral contraceptive is consumed It takes approximately 60-90 minutes for concentrations of hormones to peak in the blood following ingestion therefore measurements of cognitive function and substrate metabolism will be taken at this time Cognitive function will be measured using a battery of tests administered orally or via a laptop and substrate metabolism will be measured by collecting expired air via a mouthpiece at rest and during exercise on a treadmill during which time perceived difficulty of the exercise rate of perceived exertion and feelings felt arousal will be measured Venous blood samples will be drawn at baseline immediately before consumption of first pillplacebo and 90 minutes following this The participants will consume either the placebo or oral contraceptive whichever was not initially consumed following the testing protocol to ensure that their contraceptive protection is maintained
The proposed study will use participants that currently use a specific preparation of oral contraceptive 30micrograms ethinyl estradiol and 150mg Levonorgestrel and compare cognitive function and substrate metabolism on an occasion when a placebo is consumed lactose - no hormones to an occasion when their oral contraceptive is consumed It takes approximately 60-90 minutes for concentrations of hormones to peak in the blood following ingestion therefore measurements of cognitive function and substrate metabolism will be taken at this time Cognitive function will be measured using a battery of tests administered orally or via a laptop and substrate metabolism will be measured by collecting expired air via a mouthpiece at rest and during exercise on a treadmill during which time perceived difficulty of the exercise rate of perceived exertion and feelings felt arousal will be measured Venous blood samples will be drawn at baseline immediately before consumption of first pillplacebo and 90 minutes following this The participants will consume either the placebo or oral contraceptive whichever was not initially consumed following the testing protocol to ensure that their contraceptive protection is maintained
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