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Energy Deficiency on Hormones in Contraceptive Users

10. juni 2026 opdateret af: Todd Schroeder, University of Southern California

Effects of a Modest Energy Deficit on Reproductive Hormones Across the Menstrual Cycle in Contraceptive Users

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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. The investigators will be focusing on oral contraceptive users, hormonal IUD, and non-hormonal (i.e., copper IUD). Daily urinary hormone metabolite tracking and comprehensive metabolic assessments (i.e., resting metabolic rate, body composition via DXA, exercise logs, and energy intake) will be used to provide foundational data addressing an important and previously unexamined interaction between energy availability and hormonal regulation in contraceptive users.

Based on evidence that female reproductive hormones are sensitive to energetic stress, that estrogen plays a central role in regulating metabolism and endocrine function, and that hormonal contraceptive methods differentially alter endogenous hormone profiles, the central hypothesis of this study is that a modest, controlled energy deficiency (~250 kcal/day) will alter reproductive hormone profiles across the menstrual cycle in recreationally active women using contraceptives. Specifically, it is hypothesized that changes in urinary reproductive hormone measures will be detectable during an energy-deficient cycle compared to a baseline cycle, and that the magnitude and pattern of these changes will differ by contraceptive type, with hormonal oral contraceptive users demonstrating a different hormonal response to energy deficiency than copper or hormonal intrauterine device users.

A secondary hypothesis is that energy deficiency-induced hormonal changes will be associated with alterations in resting metabolic rate and body composition, and that these associations may be moderated by exercise energy expenditure and perceived stress. Collectively, these hypotheses are grounded in prior research demonstrating hormonal sensitivity to energetic perturbations and the distinct endocrine environments created by different contraceptive methods, while addressing a clear gap in the current literature regarding the interaction between energy availability and hormonal regulation in contraceptive users.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater, 90033
        • University of Southern California Health Sciences Campus Center for Health Professions
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • 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
  • Non-pregnant or planning to become pregnant
  • Medically free from chronic diseases
  • Currently using one of the following contraceptive methods for ≥3 months:

Monophasic oral contraceptive

  • Hormonal intrauterine device (H-IUD)
  • Copper intrauterine device
  • Weight stable (no weight change >5% body weight within the past 3 months)
  • Weight greater than or equal to 110 lbs
  • Not suffering from known gynecological disease (i.e., PCOS, endometriosis, etc.) that may influence menstrual cycle regularity
  • Willing and able to maintain current exercise habits throughout the study
  • Willing to follow study dietary guidance to achieve a ~250 kcal/day energy deficit during Cycle 2

Exclusion Criteria:

  • 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.)
  • Initiation or change of contraceptive method within the past 3 months
  • Diagnosis of polycystic ovary syndrome (PCOS), endometriosis, hypothalamic amenorrhea, or other known reproductive endocrine disorder
  • Current or history of eating disorder or clinically diagnosed disordered eating
  • Current participation in intentional weight loss or weight gain program
  • Use of medications known to affect metabolism or hormone levels (e.g., systemic corticosteroids, thyroid medications, insulin, GLP-1 agonists)
  • Known metabolic, cardiovascular, renal, hepatic, or endocrine disease
  • Musculoskeletal injury limiting exercise participation within the past 3 months
  • Smoking or nicotine use
  • Contraindications to DXA scanning (e.g., pregnancy, recent high-radiation diagnostic imaging exceeding institutional limits)
  • Inability or unwillingness to comply with study procedures

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Screening
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Monophasic low dose oral contraceptive users
The first group will be only individuals who are on a low dose, monophasic oral contraceptive that they have elected to be on prior to enrollment in the study. They will undergo a baseline monitoring menstrual cycle that will include daily urinary hormone monitoring, baseline metabolic and body composition assessments, and assessment of baseline energy expenditure and energy intake. During a two week washout week, participants will not be monitoring hormones, but will be subjected to a ~250 kcal/day energy deficit. Following this imposed energy deficiency, they will resume urinary metabolite testing and exercise intake and expenditure tracking. They will undergo this monitoring for a final menstrual cycle and metabolic and body composition assessments, and assessment of energy expenditure and energy intake.
Adfærdsmæssigt: Energy Deficiency of approximately ~250 kcal/day
Following 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.
Eksperimentel: Hormonal IUD
The second group will be only individuals who have a hormonal IUD that they have elected to be on prior to enrollment in the study. They will undergo a baseline monitoring menstrual cycle that will include daily urinary hormone monitoring, baseline metabolic and body composition assessments, and assessment of baseline energy expenditure and energy intake. During a two week washout week, participants will not be monitoring hormones, but will be subjected to a ~250 kcal/day energy deficit. Following this imposed energy deficiency, they will resume urinary metabolite testing and exercise intake and expenditure tracking. They will undergo this monitoring for a final menstrual cycle and metabolic and body composition assessments, and assessment of energy expenditure and energy intake.
Adfærdsmæssigt: Energy Deficiency of approximately ~250 kcal/day
Following 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.
Eksperimentel: Non-Hormonal (i.e., Copper) IUD
The last group will be only individuals who have a non-hormonal/copper IUD that they have elected to be on prior to enrollment in the study. They will undergo a baseline monitoring menstrual cycle that will include daily urinary hormone monitoring, baseline metabolic and body composition assessments, and assessment of baseline energy expenditure and energy intake. During a two week washout week, participants will not be monitoring hormones, but will be subjected to a ~250 kcal/day energy deficit. Following this imposed energy deficiency, they will resume urinary metabolite testing and exercise intake and expenditure tracking. They will undergo this monitoring for a final menstrual cycle and metabolic and body composition assessments, and assessment of energy expenditure and energy intake
Adfærdsmæssigt: Energy Deficiency of approximately ~250 kcal/day
Following 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Urinary hormone exposure
Tidsramme: From enrollment to energy deficit menstrual cycle is 3 months/90 days
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.
From enrollment to energy deficit menstrual cycle is 3 months/90 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Estimated versus actual resting metabolic rate
Tidsramme: From enrollment to completion 90 days/3 months
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.
From enrollment to completion 90 days/3 months
Eating behaviors and attitudes will be measured using the EDEQ and the Three Factor Eating Questionnaire
Tidsramme: From enrollment to conclusion 90 days/3 months
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).
From enrollment to conclusion 90 days/3 months
Subjective stress levels will measured using the Perceived Stress Scale
Tidsramme: From enrollment to conclusion 90 days/3 months
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).
From enrollment to conclusion 90 days/3 months
Low Energy Availability Indicators will be assessed using the LEAF-Q
Tidsramme: From enrollment to conclusion 90 days/3 months
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.
From enrollment to conclusion 90 days/3 months
Body composition will be measured using DXA
Tidsramme: From enrollment to conclusion 90 days/3 months
Dual-energy x-ray absorbtometry will be used to assess body composition including segmental analysis of body fat and lean mass.
From enrollment to conclusion 90 days/3 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Southern California

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

1. juni 2027

Studieafslutning (Anslået)

1. december 2027

Datoer for studieregistrering

Først indsendt

23. april 2026

Først indsendt, der opfyldte QC-kriterier

10. juni 2026

Først opslået (Faktiske)

16. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • HS-26-00204

Plan for individuelle deltagerdata (IPD)

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