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NCT Number: NCT06471582

Timing of Energy Availability on Menstrual Cycle Function

The primary aim of this clinical trial is to evaluate how fasted prolonged exercise may influence circulating reproductive hormones (i.e., estradiol, progesterone, luteinizing hormone) and menstrual cycle length when energy availability is maintained at or above 30 kcal/kg lean body mass/ day among women who regularly do running or cycling exercise. A secondary aim is to determine the effects of fasted prolonged exercise on serum leptin and cortisol.

Participants will be asked to do the following over a ~3 month enrollment period:

* attend a laboratory visit at the beginning of the study to have their resting metabolic rate, aerobic fitness, and body composition tested * monitor their menstrual cycle length, urine hormones, perceived stress levels, and diet for ~3 months * complete 3, 90-minute exercise sessions on a stationary bike or treadmill either fed (consuming a carbohydrate meal 1 h prior and 0.7 g carbohydrate/ kg body mass/ h during exercise) or fasted (consuming no meal prior and no carbohydrates during exercise) during month ~3 * saliva samples will be taken prior to and after 90-minute exercise sessions for quantification of leptin and cortisol

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

William J. Hybl Sports Medicine and Performance Center

Colorado Springs, Colorado, 80918, United States

Location status: Recruiting

Location contact

Marissa Baranauskas, PhD

CONTACT

[email protected]

719-255-4475

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • participates in structured running or cycling exercise for at least 30 minutes on 3 or more days per week
  • accustomed to exercising for 90 minutes or more
  • has regular periods every 21-35 days
  • have not taken hormonal contraceptives for at least the past 6 months
  • is not currently or trying to become pregnant or breastfeeding, and has not been pregnant or breastfeeding in the past 12 months
  • does not currently have a diagnosis of a major menstrual cycle disorder (i.e., amenorrhea, polycystic ovary syndrome [PCOS], endometriosis, ovarian cancer, ovarian insufficiency, uterine or endometrial cancer)
  • does not currently have a metabolic disease (i.e., hypothyroidism, hyperthyroidism, Cushing disease, Addison's disease, diabetes, congenital adrenal hyperplasia)
  • does not currently have a major cardiovascular or respiratory disease

Exclusion criteria

  • miss more than 7 consecutive days of aerobic activity (i.e., running, cycling, cross training)
  • demonstrate clinical low energy availability as defined as energy availability <30 kcal/kg fat free mass
  • report menstrual cycle lengths <21 or >35 days in the first 2 months of at-home monitoring
  • do not demonstrate an anticipated rise in luteinizing hormone and progesterone in the first 2 months of at-home monitoring
  • begin taking a hormonal contraceptive
  • become pregnant
  • are diagnosed with a menstrual cycle disorder (i.e., amenorrhea, polycystic ovary syndrome [PCOS], endometriosis, ovarian cancer, ovarian insufficiency, uterine, or endometrial cancer)
  • are diagnosed with a metabolic disease (i.e., hypothyroidism, hyperthyroidism, Cushing disease, Addison's disease, diabetes)
  • are diagnosed with a major cardiovascular or respiratory disease
  • are unable to follow instructions for any of the procedures

Treatment and study plan

Artificially Sweetened Carbohydrate Beverage

Dietary Supplement

Beverage containing 0.7 g carbohydrate/ kg body mass/ h as a 2:1 mixture of glucose and fructose and artificial sweetener

Artificially Sweetened Beverage

Dietary Supplement

Beverage containing no carbohydrates or kilocalories and an artificial sweetener

Primary outcomes

  1. Urinary estrone-3-glucuronide (E3G)

    Time frame: 3 months

    ng/mL

  2. Urinary pregnanediol glucuronide (PdG)

    Time frame: 3 months

    ug/mL

  3. Urinary luteinizing hormone (LH)

    Time frame: 3 months

    MIU/mL

  4. Menstrual cycle length

    Time frame: 3 months

    days

Secondary outcomes

  1. Salivary cortisol

    Time frame: 3 days

    ng/mL

  2. Salivary leptin

    Time frame: 3 days

    ng/mL

Study contacts

Contact information is provided by the study sponsor or research team.

Marissa Baranauskas, PhD

CONTACT

[email protected]

719-255-4475

Sponsors and collaborators

Lead sponsor

University of Colorado, Colorado Springs

Other

Registry information

Official study title

Implications for the Timing of Energy Availability on Menstrual Cycle Function

Acronym: FAST

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 24, 2024
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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