Clinical trial NCT06560944: Oral Contraceptive Consumption Timing and Cognition and Metabolism
Official title: Effects of Oral Contraceptive Consumption Timing on Cognition and Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Change
Lead sponsor: University of Lincoln
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomised-controlled crossover trial
Primary purpose: OTHER

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Female
* Aged 18-35 years
* The use of the same oral contraceptive (30 micrograms ethinyl estradiol and 150mg levonorgestrel) for at least 6 months
* Physically active and able to take part in treadmill-based exercise
* Speak fluent English

Exclusion Criteria:

* Use of any other type of hormonal contraception
* Aged \< 18 or \> 35 years
* Poly-cystic ovarian syndrome
* Endometriosis
* Pregnant
* Child birth or lactation in the previous 6 months
* Body mass index \< 18.5 or \> 30 kg.m2
* Any disorder known to affect metabolic health
* History of head injury/neurological disorders
* Use of any steroid-based medication or medications known to influence the central nervous system
* History of psychiatric disorders such as major depression or an anxiety disorder
* Smokers
* Suffer from (or have suffered from) a heart complaint
* Advised by medical professional to refrain from high intensity exercise
* Current muscle or joint injury

Primary outcomes:
measure: Rey Auditory Verbal Test Performance
timeFrame: 60-90 minutes post oral contraceptive/placebo ingestion
measure: Mental Rotation test
timeFrame: 60-90 minutes post oral contraceptive/placebo ingestion
measure: Verbal Fluency
timeFrame: 60-90 minutes post oral contraceptive/placebo ingestion
measure: Stroop test
timeFrame: 60-90 minutes post oral contraceptive/placebo ingestion
measure: Corsi blocks
timeFrame: 60-90 minutes post oral contraceptive/placebo ingestion
measure: Rapid Visual Information Processing
timeFrame: 60-90 minutes post oral contraceptive/placebo ingestion
measure: Rating of perceived exertion
timeFrame: 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
measure: Felt arousal
timeFrame: 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
measure: Feeling scale
timeFrame: 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
measure: Heart rate
timeFrame: 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
measure: Carbohydrate oxidation
timeFrame: 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
measure: Fat oxidation
timeFrame: 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
measure: Respiratory exchange ratio
timeFrame: 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
measure: Breathing frequency
timeFrame: 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
measure: Maximal oxygen consumption (VO2max)
timeFrame: During maximal exercise test which occurs approximately 110 minutes post oral contraceptive/placebo ingestion
measure: Time to exhaustion
timeFrame: During maximal exercise test which occurs approximately 110 minutes post oral contraceptive/placebo ingestion
measure: Maximal heart rate
timeFrame: During maximal exercise test which occurs approximately 110 minutes post oral contraceptive/placebo ingestion
Secondary outcomes:
measure: Seum ethinyl estradiol
timeFrame: Baseline and immediately post cognitive function tests
measure: Serum Levonorgestrel
timeFrame: Baseline and immediately post cognitive function tests
Other outcomes:
Locations:
city: Lincoln
country: United Kingdom
facility: Dan Martin
state: Lincolnshire
Study officials:
affiliation: University of Lincoln
name: Dan Martin, PhD
role: PRINCIPAL_INVESTIGATOR
References: