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NCT06471582 · ClinicalTrials.gov registry record · NA
Timing of Energy Availability on Menstrual Cycle Function
A NA study of Menstrual Irregularity, sponsored by University of Colorado, Colorado Springs.
- Recruiting
- Registry status
- NA
- Development phase
- 64
- Enrollment target
- 1
- Study location
NCT06471582 is a NA study of Menstrual Irregularity that is actively recruiting participants, run by University of Colorado, Colorado Springs. The registered enrollment target is 64 participants. The trial reports 1 study location across 1 state.
The verdict
NCT06471582, a NA study of Menstrual Irregularity, is actively recruiting participants, sponsored by University of Colorado, Colorado Springs.
- RECRUITING
- Registry status
- NA
- Development phase
- 64 participants
- Enrollment target
- 1
- Study location
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 Studied
Interventions
- DIETARY_SUPPLEMENT Artificially Sweetened Carbohydrate Beverage
- DIETARY_SUPPLEMENT Artificially Sweetened Beverage
Study Locations (1)
Colorado
- William J. Hybl Sports Medicine and Performance Center - Colorado Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2024-08-01 |
| Est. Completion | 2027-08-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06471582
The ClinicalTrials.gov registry entry for NCT06471582 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Colorado Springs, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Menstrual Irregularity appearing as the primary indexed condition, and to 2 interventions - of which Artificially Sweetened Carbohydrate Beverage is the first listed.
NCT06471582 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.
Frequently Asked Questions
What is clinical trial NCT06471582 about?
NCT06471582 is a clinical study titled "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 ...
What is the current status of trial NCT06471582?
This trial is currently recruiting. It is a NA study. The enrollment target is 64 participants. The study started on 2024-08-01. Estimated completion is 2027-08-31.
What conditions does trial NCT06471582 study?
This clinical trial studies the following conditions: Menstrual Irregularity.
What interventions are being tested in trial NCT06471582?
The interventions under investigation include: Artificially Sweetened Carbohydrate Beverage (DIETARY_SUPPLEMENT), Artificially Sweetened Beverage (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT06471582?
This trial is sponsored by University of Colorado, Colorado Springs, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06471582 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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