Menstrual Irregularity
Conditions
Keywords
functional hypothalamic amenorrhea, menstrual cycle, female athlete
Brief 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
Interventions
DIETARY_SUPPLEMENTArtificially 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_SUPPLEMENTArtificially Sweetened Beverage
Beverage containing no carbohydrates or kilocalories and an artificial sweetener
Sponsors
University of Colorado, Colorado Springs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urinary estrone-3-glucuronide (E3G) | 3 months | ng/mL |
| Urinary pregnanediol glucuronide (PdG) | 3 months | ug/mL |
| Urinary luteinizing hormone (LH) | 3 months | MIU/mL |
| Menstrual cycle length | 3 months | days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Salivary cortisol | 3 days | ng/mL |
| Salivary leptin | 3 days | ng/mL |
Countries
United States
Contacts
CONTACTMarissa Baranauskas, PhD
Outcome results
None listed