Dan Martin
Lincoln, Lincolnshire, LN6 7TS, United Kingdom
NCT Number: NCT06560944
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.
Looking for future studies?
Notify Me18 year–35 year
Female
Interventional
Not applicable
Lincoln, Lincolnshire, LN6 7TS, United Kingdom
Reproductive hormones, such as oestrogen and progesterone, are known to affect cognitive function (i.e. thinking, learning and processing information) and substrate metabolism (i.e. 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 pill/placebo) 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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ingesting their existing combined oral contraceptive pill at a specific time of day in relation to assessment of outcome measures
Time frame: 60-90 minutes post oral contraceptive/placebo ingestion
Acquisition, Learning rate, Proactive Interference, Retroactive interference, Forgetting
Time frame: 60-90 minutes post oral contraceptive/placebo ingestion
Accuracy, Response time
Time frame: 60-90 minutes post oral contraceptive/placebo ingestion
Words said
Time frame: 60-90 minutes post oral contraceptive/placebo ingestion
Accuracy, Response time
Time frame: 60-90 minutes post oral contraceptive/placebo ingestion
Correct sequences, longest sequence
Time frame: 60-90 minutes post oral contraceptive/placebo ingestion
Proportion correct, Response time
Time frame: During final minute of of 6 minutes exercise at both 70 and 90% lactate threshold. Exercise takes place approximately 90 minutes post oral contraceptive/placebo ingestion
Borg rating of perceived exertion (RPE) scale from 6-20. Higher value indicates greater exertion
Time frame: During final minute of of 6 minutes exercise at both 70 and 90% lactate threshold. Exercise takes place approximately 90 minutes post oral contraceptive/placebo ingestion
Felt arousal scale from 1-6. Higher value indicates greater level of arousal
Time frame: During final minute of of 6 minutes exercise at both 70 and 90% lactate threshold. Exercise takes place approximately 90 minutes post oral contraceptive/placebo ingestion
Feeling scale -5 to +5. Higher value indicates more positive feeling.
Time frame: During final minute of of 6 minutes exercise at both 70 and 90% lactate threshold. Exercise takes place approximately 90 minutes post oral contraceptive/placebo ingestion
beats per minute
Time frame: During final minute of of 6 minutes exercise at both 70 and 90% lactate threshold. Exercise takes place approximately 90 minutes post oral contraceptive/placebo ingestion
Rate of carbohydrate use
Time frame: During final minute of of 6 minutes exercise at both 70 and 90% lactate threshold. Exercise takes place approximately 90 minutes post oral contraceptive/placebo ingestion
Rate of fat use
Time frame: During final minute of of 6 minutes exercise at both 70 and 90% lactate threshold. Exercise takes place approximately 90 minutes post oral contraceptive/placebo ingestion
Ratio of carbohydrate and fat metabolism
Time frame: During final minute of of 6 minutes exercise at both 70 and 90% lactate threshold. Exercise takes place approximately 90 minutes post oral contraceptive/placebo ingestion
breaths per minute
Time frame: During maximal exercise test which occurs approximately 110 minutes post oral contraceptive/placebo ingestion
Maximal rate of oxygen used
Time frame: During maximal exercise test which occurs approximately 110 minutes post oral contraceptive/placebo ingestion
Time before test termination
Time frame: During maximal exercise test which occurs approximately 110 minutes post oral contraceptive/placebo ingestion
Maximal heart rate achieved
Time frame: Baseline and immediately post cognitive function tests
Synthetic oestrogen concentrations in blood
Time frame: Baseline and immediately post cognitive function tests
Synthetic progesterone concentrations in blood
University of Lincoln
Other
Effects of Oral Contraceptive Consumption Timing on Cognition and Metabolism
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05177679
Achievement, Cognitive Change
Urbana, Illinois, United States
View Trial DetailsNCT05138848
Alzheimer Disease, Alzheimer Disease, Late Onset
Pittsburgh, Pennsylvania, United States
View Trial DetailsNCT06107075
Behavior, Cognitive Change
Newcastle upon Tyne, United Kingdom
View Trial DetailsNCT05855434
COVID-19, Cognition Disorders
Aberdeen, Grampian, United Kingdom
View Trial Details