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Energy Deficiency on Hormones in Contraceptive Users

2026년 6월 10일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

30

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Emily Lundstrom, PhD
  • 전화번호: 3234422180
  • 이메일: elundstr@usc.edu

연구 장소

  • 미국
    • California
      • Los Angeles, California, 미국, 90033
        • University of Southern California Health Sciences Campus Center for Health Professions
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 상영
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
행동: 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.
실험적: 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.
행동: 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.
실험적: 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
행동: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Urinary hormone exposure
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Estimated versus actual resting metabolic rate
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Southern California

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 9월 1일

기본 완료 (추정된)

2027년 6월 1일

연구 완료 (추정된)

2027년 12월 1일

연구 등록 날짜

최초 제출

2026년 4월 23일

QC 기준을 충족하는 최초 제출

2026년 6월 10일

처음 게시됨 (실제)

2026년 6월 16일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 16일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 10일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • HS-26-00204

개별 참가자 데이터(IPD) 계획

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아니요

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