Cognitive ChangeNCT06560944
Oral Contraceptive Consumption Timing and Cognition and Metabolism
A study testing Combined oral contraceptive pill in people with Cognitive Change, run by University of Lincoln at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change
- What is being tested?
- Combined oral contraceptive pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Jan 2020to 20 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Oral Contraceptive Consumption Timing on 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.
Read the 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.
- Conditions
- Cognitive Change
- Being tested
- Combined oral contraceptive pill
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined oral contraceptive pillDrug
Ingesting their existing combined oral contraceptive pill at a specific time of day in relation to assessment of outcome measures
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Combined oral contraceptive pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rey Auditory Verbal Test Performance
Acquisition, Learning rate, Proactive Interference, Retroactive interference, Forgetting
Measured: 60-90 minutes post oral contraceptive/placebo ingestion
Mental Rotation test
Accuracy, Response time
Measured: 60-90 minutes post oral contraceptive/placebo ingestion
Verbal Fluency
Words said
Measured: 60-90 minutes post oral contraceptive/placebo ingestion
Stroop test
Accuracy, Response time
Measured: 60-90 minutes post oral contraceptive/placebo ingestion
Corsi blocks
Correct sequences, longest sequence
Measured: 60-90 minutes post oral contraceptive/placebo ingestion
Rapid Visual Information Processing
Proportion correct, Response time
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: During maximal exercise test which occurs approximately 110 minutes post oral contraceptive/placebo ingestion
Time to exhaustion
Time before test termination
Measured: During maximal exercise test which occurs approximately 110 minutes post oral contraceptive/placebo ingestion
Maximal heart rate
Maximal heart rate achieved
Measured: During maximal exercise test which occurs approximately 110 minutes post oral contraceptive/placebo ingestion
Secondary outcomes (2)
Seum ethinyl estradiol
Synthetic oestrogen concentrations in blood
Measured: Baseline and immediately post cognitive function tests
Serum Levonorgestrel
Synthetic progesterone concentrations in blood
Measured: Baseline and immediately post cognitive function tests
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start17 Jan 2020
- Primary completion20 Jan 2024
- Study completion20 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomised-controlled crossover trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lincoln
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dan Martin, PhD, Principal investigator, University of Lincoln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06560944
- Sponsor's protocol ID
- 718
- Status last verified
- Aug 2024
- First submitted
- 27 Jun 2023
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral Contraceptive Consumption Timing on Cognition and Metabolism
- ClinicalTrials.gov ID
- NCT06560944
- Acronym / sponsor ID
- 718
- Conditions
- Cognitive Change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of LincolnUniversity, hospital or other
- Study start
- 17 Jan 2020 (actual)
- Primary completion
- 20 Jan 2024 (actual)
- Study completion
- 20 Jan 2024 (actual)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomised-controlled crossover trial
| Arm | Type | Receives |
|---|---|---|
| Oral contraceptive | Experimental | Drug: Combined oral contraceptive pillParticipants existing oral contraceptive to be ingested at 8am on a day between 3 to 21 of pill consumption. Placebo consumed ~2 hours later |
| Placebo | Placebo comparator | Drug: Combined oral contraceptive pillPlacebo ingested at 8am on a day between 3 to 21 of pill consumption. Participants existing oral contraceptive consumed ~2 hours later |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- Use of any other type of hormonal contraception
- Aged < 18 or > 35 years
- Poly-cystic ovarian syndrome
- Endometriosis
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined oral contraceptive pillIngesting their existing combined oral contraceptive pill at a specific time of day in relation to assessment of outcome measures | Drug | Oral contraceptive, Placebo |
Primary outcome
Rey Auditory Verbal Test Performance
Time frame: 60-90 minutes post oral contraceptive/placebo ingestion
Acquisition, Learning rate, Proactive Interference, Retroactive interference, Forgetting
Mental Rotation test
Time frame: 60-90 minutes post oral contraceptive/placebo ingestion
Accuracy, Response time
Verbal Fluency
Time frame: 60-90 minutes post oral contraceptive/placebo ingestion
Words said
Stroop test
Time frame: 60-90 minutes post oral contraceptive/placebo ingestion
Accuracy, Response time
Corsi blocks
Time frame: 60-90 minutes post oral contraceptive/placebo ingestion
Correct sequences, longest sequence
Rapid Visual Information Processing
Time frame: 60-90 minutes post oral contraceptive/placebo ingestion
Proportion correct, Response time
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
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
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.
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
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
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
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
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
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
Time to exhaustion
Time frame: During maximal exercise test which occurs approximately 110 minutes post oral contraceptive/placebo ingestion
Time before test termination
Maximal heart rate
Time frame: During maximal exercise test which occurs approximately 110 minutes post oral contraceptive/placebo ingestion
Maximal heart rate achieved
2 secondary outcomes
Seum ethinyl estradiol
Time frame: Baseline and immediately post cognitive function tests
Serum Levonorgestrel
Time frame: Baseline and immediately post cognitive function tests
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Cognitive Change
Recruiting
Telehealth-Adapted Compensatory Training and Intervention for Cognition
MCI, Mild Cognitive Impairment
Recruiting
Neurobehavioral Changes Following Spaceflight Stressors
Stressor, Individual, Alcohol Impairment
RecruitingPhase 1
A Study of LY3439539 in Participants With Alzheimer's Disease
Alzheimer Disease
Not yet recruiting
Magnetoencephalographic Correlates of Clinical Change After Cognitive Processing Therapy in Adults With PTSD
Trauma, Psychological, Traumatic Stress Disorder
Not yet recruiting
Measuring Brain Changes Following Cognitive Intervention in Pediatric Patients With Brain Tumors
Brain Tumor, Pediatric
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan Martin, PhD principal investigator
University of Lincoln
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined oral contraceptive pill in people with Cognitive Change, run by University of Lincoln at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rey Auditory Verbal Test Performance (time frame: 60-90 minutes post oral contraceptive/placebo ingestion). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.