Skip to main content
OpenTrials
Completed

NCT Number: NCT06560944

Oral Contraceptive Consumption Timing and Cognition and Metabolism

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dan Martin

Lincoln, Lincolnshire, LN6 7TS, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Combined Oral Contraceptive Pill

Drug

Ingesting their existing combined oral contraceptive pill at a specific time of day in relation to assessment of outcome measures

Primary outcomes

  1. Rey Auditory Verbal Test Performance

    Time frame: 60-90 minutes post oral contraceptive/placebo ingestion

    Acquisition, Learning rate, Proactive Interference, Retroactive interference, Forgetting

  2. Mental Rotation test

    Time frame: 60-90 minutes post oral contraceptive/placebo ingestion

    Accuracy, Response time

  3. Verbal Fluency

    Time frame: 60-90 minutes post oral contraceptive/placebo ingestion

    Words said

  4. Stroop test

    Time frame: 60-90 minutes post oral contraceptive/placebo ingestion

    Accuracy, Response time

  5. Corsi blocks

    Time frame: 60-90 minutes post oral contraceptive/placebo ingestion

    Correct sequences, longest sequence

  6. Rapid Visual Information Processing

    Time frame: 60-90 minutes post oral contraceptive/placebo ingestion

    Proportion correct, Response time

  7. Rating of perceived 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

    Borg rating of perceived exertion (RPE) scale from 6-20. Higher value indicates greater exertion

  8. Felt 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

    Felt arousal scale from 1-6. Higher value indicates greater level of arousal

  9. Feeling scale

    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.

  10. Heart rate

    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

  11. Carbohydrate oxidation

    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

  12. Fat oxidation

    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

  13. Respiratory exchange ratio

    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

  14. Breathing frequency

    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

  15. Maximal oxygen consumption (VO2max)

    Time frame: During maximal exercise test which occurs approximately 110 minutes post oral contraceptive/placebo ingestion

    Maximal rate of oxygen used

  16. Time to exhaustion

    Time frame: During maximal exercise test which occurs approximately 110 minutes post oral contraceptive/placebo ingestion

    Time before test termination

  17. Maximal heart rate

    Time frame: During maximal exercise test which occurs approximately 110 minutes post oral contraceptive/placebo ingestion

    Maximal heart rate achieved

Secondary outcomes

  1. Seum ethinyl estradiol

    Time frame: Baseline and immediately post cognitive function tests

    Synthetic oestrogen concentrations in blood

  2. Serum Levonorgestrel

    Time frame: Baseline and immediately post cognitive function tests

    Synthetic progesterone concentrations in blood

Sponsors and collaborators

Lead sponsor

University of Lincoln

Other

Registry information

Official study title

Effects of Oral Contraceptive Consumption Timing on Cognition and Metabolism

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Aug 19, 2024
Registry last updated
Aug 21, 2024

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.