Oral Contraceptive Consumption Timing and Cognition and Metabolism
NCT Number: NCT06560944
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cognitive Change
Interventions: DRUG: Combined oral contraceptive pill
Sponsor: University of Lincoln
Sex: FEMALE
Age: ADULT
Enrollment: 16
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: OTHER
Start Date: 2020-01-17
Completion Date: 2024-01-20
Locations: Dan Martin, Lincoln, Lincolnshire, LN6 7TS, United Kingdom

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.

Primary Outcome Measures: 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 Outcome Measures: Seum ethinyl estradiol, Synthetic oestrogen concentrations in blood, Baseline and immediately post cognitive function tests|Serum Levonorgestrel, Synthetic progesterone concentrations in blood, Baseline and immediately post cognitive function tests