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Timing of Energy Availability on Menstrual Cycle Function

NCT06471582 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2026-05-01

No results posted yet for this study

Summary

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

Conditions

  • Menstrual Irregularity

Interventions

DIETARY_SUPPLEMENT

Artificially Sweetened Carbohydrate Beverage

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

DIETARY_SUPPLEMENT

Artificially Sweetened Beverage

Beverage containing no carbohydrates or kilocalories and an artificial sweetener

Sponsors & Collaborators

  • University of Colorado, Colorado Springs

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2027-08-31
Completion
2027-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06471582 on ClinicalTrials.gov