Energy Deficiency on Hormones in Contraceptive Users
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-35
SponsorUniversity of Southern California
About this trial
The purpose of the present study is to characterize the endocrine and metabolic responses to a modest, short-term energy deficiency (\~250 kcal/day) across the menstrual cycle in recreationally active women using different contraceptive methods (oral contraceptive, hormonal IUD, and non-hormonal IUD). This study will leverage daily urinary hormone metabolite tracking and comprehensive metabolic assessments, providing foundational data addressing an important and previously unexamined interaction between energy availability and hormonal regulation in contraceptive users.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female, aged 18-35 years
Recreationally active (engaging in structured exercise between 8-15 hours per week)
BMI of 18.5-29.9 as a BMI below or above these cut points results in highly varied menstrual cycle lengths17
Not currently experiencing an eating disorder or disordered eating, or having a diagnosed eating disorder in the last 3 years
Disqualifiers
Amenorrhea or oligomenorrhea
Perimenopausal or menopausal
Currently pregnant, planning pregnancy, or breastfeeding
Use of hormonal contraception other than monophasic oral contraceptives or hormonal IUD (implant, nuvaring, etc.)
Trial design
Design model
Parallel
Treatments tested in this trial
Energy Deficiency of approximately ~250 kcal/day
BehavioralFollowing an initial baseline menstrual cycle, participants will be subjected to at least two weeks of a \~250 kcal/day energy deficit monitored through daily diet tracking.
Treatment groups
30 Participants
are divided into 3 treatment groupsGroup A: Monophasic low dose oral contraceptive usersExperimental treatment 1 intervention
Group B: Hormonal IUDExperimental treatment 1 intervention
Group C: Non-Hormonal (i.e., Copper) IUDExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Urinary hormone exposure
Participants will be asked to track daily urine concentrations of estrogen and progesterone throughout a baseline (i.e., non-energy-deficient state) menstrual cycle and a menstrual cycle with an imposed energy deficit. The outcome will compare hormone exposure measured by the urinary concentrations between the two cycles.
Time frame
From enrollment to energy deficit menstrual cycle is 3 months/90 daysSecondary outcomes
1
Estimated versus actual resting metabolic rate
Body composition and estimated metabolic rate will be collected using DXA. The DXA will be measured at baseline and at the conclusion of the energy-deficient menstrual cycle. Resting metabolic rate will be measured via indirect calorimetry testing at baseline, at the beginning of the second monitored (i.e., energy-deficient) menstrual cycle, and at the conclusion of the energy-deficient menstrual cycle. The estimated and actual metabolic rate will be compared as an assessment of energy status. Participants will also be asked to track exercise using a paper log or wearable device to estimate exercise energy expenditure (EEE), and daily intake (EI) will be measured via a paper log or an application. These values will be subtracted (EI-EEE) and normalized to fat-free mass collected via DXA to estimate energy availability.
Time frame
From enrollment to completion 90 days/3 months2
Eating behaviors and attitudes will be measured using the EDEQ and the Three Factor Eating Questionnaire
The Eating Disorder Examination Questionnaire is a 12 item questionnaire scaled from 0 to 3 (0 being 0 days and 3 being 6 to 7 days) assessing feelings around eating behaviors, body image, and restraint. The Three Factor Eating questionnaire is an 18-question survey that assesses cognitive restraint, emotional eating, and uncontrolled eating on a 4 point Likert scale (0 being never and 3 being at least once a week).
Time frame
From enrollment to conclusion 90 days/3 months3
Subjective stress levels will measured using the Perceived Stress Scale
The Subjective Stress Scale measures percieved stress through 10 questions about recent stress perceptions on a 0 to 4 Likert scale (0 being never; and 4 being very often).
Time frame
From enrollment to conclusion 90 days/3 months4
Low Energy Availability Indicators will be assessed using the LEAF-Q
The low energy availability in Females Questionnaire (LEAF-Q) is used to identify female athletes 'at risk' of low energy availability. This questionnaire assesses physiological symptoms associated with LEA, including 25 questions arranged into 3 sections; eating and reproductive assessment, injury assessment, and gastrointestinal symptom assessment. A total score of ≥8 out of 25 questions indicates that the athlete is at risk of LEA. There is a standardized scoring system that varies by question and subquestion.
Time frame
From enrollment to conclusion 90 days/3 monthsSponsors and contacts
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Source ClinicalTrials.gov
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