Oral Contraceptive Consumption Timing and Cognition and Metabolism

NCT06560944 | Completed

• 1 other identifier: 718
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Change

Outcome Measures

Primary Outcomes (17)

• Rey Auditory Verbal Test Performance

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

  60-90 minutes post oral contraceptive/placebo ingestion

• Mental Rotation test

  Accuracy, Response time

  60-90 minutes post oral contraceptive/placebo ingestion

• Verbal Fluency

  Words said

  60-90 minutes post oral contraceptive/placebo ingestion

• Stroop test

  Accuracy, Response time

  60-90 minutes post oral contraceptive/placebo ingestion

• Corsi blocks

  Correct sequences, longest sequence

  60-90 minutes post oral contraceptive/placebo ingestion

• Rapid Visual Information Processing

  Proportion correct, Response time

  60-90 minutes post oral contraceptive/placebo ingestion

• Rating of perceived exertion

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

  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

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

  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

  Feeling scale -5 to +5. Higher value indicates more positive feeling.

  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

• Heart rate

  beats per minute

  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

• Carbohydrate oxidation

  Rate of carbohydrate use

  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

• Fat oxidation

  Rate of fat use

  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

• Respiratory exchange ratio

  Ratio of carbohydrate and fat metabolism

  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

• Breathing frequency

  breaths per minute

  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

• Maximal oxygen consumption (VO2max)

  Maximal rate of oxygen used

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

• Time to exhaustion

  Time before test termination

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

• Maximal heart rate

  Maximal heart rate achieved

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

Secondary Outcomes (2)

• Seum ethinyl estradiol

  Baseline and immediately post cognitive function tests

• Serum Levonorgestrel

  Baseline and immediately post cognitive function tests

Study Arms (2)

Oral contraceptive

EXPERIMENTAL

Participants existing oral contraceptive to be ingested at 8am on a day between 3 to 21 of pill consumption. Placebo consumed \~2 hours later

Drug: Combined oral contraceptive pill

Placebo

PLACEBO COMPARATOR

Placebo ingested at 8am on a day between 3 to 21 of pill consumption. Participants existing oral contraceptive consumed \~2 hours later

Drug: Combined oral contraceptive pill

Interventions

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

Oral contraceptive; Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Lincoln: lead

Study Sites (1)

Dan Martin

Lincoln, Lincolnshire, LN6 7TS, United Kingdom

Location

MeSH Terms

Interventions

Contraceptives, Oral, Combined

Intervention Hierarchy (Ancestors)

Drug Combinations; Pharmaceutical Preparations; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses

Study Officials

• Dan Martin, PhD

  University of Lincoln

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Random number generator, via technicians, concealed allocation
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised-controlled crossover trial

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: August 19, 2024
• Study Start: January 17, 2020
• Primary Completion: January 20, 2024
• Study Completion: January 20, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)