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Energy Deficiency on Hormones in Contraceptive Users

10. června 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

30

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Emily Lundstrom, PhD
  • Telefonní číslo: 3234422180
  • E-mail: elundstr@usc.edu

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Promítání
  • Přidělení: Nerandomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Behaviorální: 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.
Experimentální: 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.
Behaviorální: 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.
Experimentální: 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
Behaviorální: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Urinary hormone exposure
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Estimated versus actual resting metabolic rate
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of Southern California

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. září 2026

Primární dokončení (Odhadovaný)

1. června 2027

Dokončení studie (Odhadovaný)

1. prosince 2027

Termíny zápisu do studia

První předloženo

23. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

10. června 2026

První zveřejněno (Aktuální)

16. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

16. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

10. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • HS-26-00204

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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