Energy Availability for Menstrual Irregularities

(FAST Trial)

Overseen By Marissa Baranauskas, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Colorado, Colorado Springs

Must not be taking: Hormonal contraceptives

Disqualifiers: Pregnancy, Amenorrhea, PCOS, Diabetes, others

Compensation: Varies

Number of Visits: 5

64 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how exercising without eating beforehand affects hormones and menstrual cycles in women who regularly run or cycle. Researchers aim to determine if exercising on an empty stomach (timing of energy availability) alters key hormones like estradiol and progesterone and impacts menstrual cycle length. They also measure levels of other hormones, such as leptin and cortisol, during exercise. Women who run or cycle for at least 30 minutes, three times a week, and have regular periods may be suitable for this study. As an unphased trial, this study provides a unique opportunity to enhance understanding of the relationship between exercise timing and hormonal health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are taking hormonal contraceptives or have certain medical conditions like metabolic or cardiovascular diseases.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that specific safety information for the Timing of Energy Availability treatment is limited. The trial is marked as "Not Applicable" in terms of phase, indicating it doesn't follow the usual phase structure, so detailed safety data might be scarce.

This treatment involves timing carbohydrate intake around exercise. It is not a medication or a complicated procedure, which generally makes it low-risk. However, due to the lack of detailed safety information, participants should stay informed and discuss any concerns with the trial team or their doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how the timing of energy availability, particularly carbohydrate intake, might influence menstrual irregularities. Unlike traditional treatments, which often involve hormonal therapies or lifestyle adjustments, this approach focuses on the timing and composition of meals relative to exercise. By investigating the impact of consuming carbohydrates before and during exercise, the trial aims to uncover whether these dietary adjustments can naturally regulate menstrual cycles, potentially offering a non-invasive alternative to current options.

What evidence suggests that this trial's treatments could be effective for menstrual irregularities?

This trial will compare different approaches to energy availability for managing menstrual irregularities. Research has shown that adjusting food intake can improve menstrual cycles in women who exercise frequently. One study found that consuming 18% more calories daily helped women with irregular or missed periods return to a normal cycle. Another study linked increased energy availability after exercise to better menstrual health, with more energy leading to fewer problems. Timing and quantity of food intake, such as having a snack before working out, may help balance hormones. These findings suggest that when and how much one eats could effectively manage menstrual issues. Participants in this trial will either consume carbohydrates before and during exercise or exercise in a fasted state to evaluate the impact on menstrual health. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for women who regularly run or cycle, are not pregnant or breastfeeding, haven't been in the past year, and don't plan to be. They should have regular menstrual cycles every 21-35 days, no major menstrual disorders like PCOS or endometriosis, no serious heart/lung diseases, and can't have taken hormonal contraceptives in the last 6 months.

Inclusion Criteria

I do not have any metabolic diseases like thyroid issues or diabetes.

I do not have any major heart or lung diseases.

Participates in structured running or cycling exercise for at least 30 minutes on 3 or more days per week

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

Do not demonstrate an anticipated rise in luteinizing hormone and progesterone in the first 2 months of at-home monitoring

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants attend a laboratory visit to have their resting metabolic rate, aerobic fitness, and body composition tested

1 day

1 visit (in-person)

Monitoring

Participants monitor their menstrual cycle length, urine hormones, perceived stress levels, and diet

3 months

Exercise Intervention

Participants complete 3, 90-minute exercise sessions on a stationary bike or treadmill, either fed or fasted

1 month

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Timing of Energy Availability

Trial Overview The study tests how exercising while fasted affects reproductive hormones and menstrual cycle length when maintaining enough daily calories from lean body mass. Participants will exercise fed or fasted on a bike/treadmill and monitor their diet, stress levels, urine hormones for about three months.

How Is the Trial Designed?

Group I: Fed with Carbohydrates Experimental Treatment 1 Intervention

Participants will complete 3, 90-minute stationary cycle or treadmill exercise sessions 1 h after consuming a meal containing 1 g carbohydrate/ kg body weight. During exercise, they will consume an artificially sweetened beverage containing 0.7 g carbohydrate/ kg body mass/ h as a 2:1 mixture of glucose and fructose.

Group II: Fasted without Carbohydrates Placebo Group 1 Intervention

Participants will complete 3, 90-minute stationary cycle or treadmill exercise sessions following an overnight fast. During exercise, they will consume an artificially sweetened beverage containing no carbohydrates.

Who Is Running the Clinical Trial?

University of Colorado, Colorado Springs

Lead Sponsor

Trials

20

Recruited

5,500+

Published Research Related to This Trial

Chronic energy deficiency leads to significant metabolic changes, including reduced levels of important hormones like IGF-1 and leptin, which can affect overall health and energy balance.

These hormonal alterations can suppress the hypothalamic-pituitary-ovarian axis, resulting in menstrual dysfunction due to decreased secretion of gonadotropin-releasing hormone and subsequent hormones like luteinizing hormone and follicle-stimulating hormone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The physiology of functional hypothalamic amenorrhea associated with energy deficiency in exercising women and in women with anorexia nervosa. Allaway, HC., Southmayd, EA., De Souza, MJ.[2016]

A systematic review of 28 studies found that certain foods and supplements, particularly vitamin D, calcium, zinc, and curcumin, may help reduce menstrual-related symptoms in naturally menstruating women, with no studies reporting negative effects.

Despite some positive findings, the review highlighted a lack of consistency in how menstrual symptoms were measured and the dosages used, indicating that more rigorous research is needed to establish clear guidelines for dietary interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional practices to manage menstrual cycle related symptoms: a systematic review. Brown, N., Martin, D., Waldron, M., et al.[2023]

In a 1-year study of 34 recreational female runners in France, no significant differences in energy or macronutrient intake were found among those with normal, irregular, or absent menstrual cycles, suggesting that diet may not directly influence menstrual health in this group.

However, the study revealed that amenorrhoeic and oligomenorrhoeic runners had significantly higher fluid and fiber intakes, consuming about twice the daily fluid intake compared to those with regular menstrual cycles, indicating a potential dietary pattern associated with menstrual cycle impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship between self-reported food and fluid intake and menstrual disturbance in female recreational runners. Rosetta, L., Condé da Silva Fraga, E., Mascie-Taylor, CG.[2019]

In a study of 4863 pregnant women, daughters of non-obese women with irregular menstrual cycles had significantly lower birth weights compared to those with regular cycles, with this effect being even more pronounced in obese women.

While the initial impact of maternal menstrual irregularity on birth weight was significant, it did not affect the daughters' growth in weight from birth to age five, indicating that the early weight differences may not have long-term implications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Birth weight and childhood growth in daughters of women with irregular menstrual cycles. Wang, ET., Cirillo, PM., Kao, CN., et al.[2021]

In a study of 352 young women from the Pittsburgh Girls Study, early menarche (before age 11) was linked to increased waist circumference, indicating potential risks for future health issues.

Adolescents with irregular menstrual cycles showed significantly higher levels of insulin, glucose, and triglycerides, as well as elevated blood pressure, suggesting that menstrual irregularity may be an important indicator of future cardiometabolic health risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Menstrual Cycle Irregularity in Adolescence Is Associated With Cardiometabolic Health in Early Adulthood. Keenan, K., Hipwell, AE., Polonsky, TS.[2023]

In a study of 14 previously sedentary, ovulatory women undergoing a 3-month diet and exercise program, reductions in energy availability (EA) were linked to a significant decrease in luteinizing hormone (LH) pulse frequency, which dropped from 0.82 to 0.63 pulses per hour.

Lower LH pulse frequency was associated with a higher risk of luteal phase defects (LPDs), with a 22-fold increase in odds for every 0.1-unit decrease in LH pulse frequency, indicating that maintaining adequate energy availability is crucial for normal menstrual function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Energy Availability Is Associated With Luteinizing Hormone Pulse Frequency and Induction of Luteal Phase Defects. Koltun, KJ., De Souza, MJ., Scheid, JL., et al.[2020]

A study involving 34 untrained women aged 18-30 showed that greater energy deficits during exercise led to more frequent menstrual disturbances, with moderate (ED2) and severe (ED3) deficits causing significantly more issues than a control group.

The research established a dose-response relationship, indicating that energy deficits of -22% to -42% (equating to -470 to -810 kcal/day) were linked to increased menstrual irregularities, although the severity of these disturbances did not depend on the level of energy deficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnitude of daily energy deficit predicts frequency but not severity of menstrual disturbances associated with exercise and caloric restriction. Williams, NI., Leidy, HJ., Hill, BR., et al.[2022]

In a study of 57 morbidly obese women, those with menstrual dysfunction (Group 2) exhibited significantly higher insulin resistance (IR) compared to those without menstrual issues (Group 1), indicating a link between IR and menstrual irregularities.

The findings suggest that insulin resistance may contribute to menstrual dysfunctions like amenorrhea or oligomenorrhea, even when hyperandrogenism is not present, highlighting its role in ovarian function and menstrual cycle regulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Menstrual irregularity: a possible clinical marker of metabolic dysfunction in women with class III obesity. Souza, FA., Dias, R., Fernandes, CE., et al.[2010]

In exercising women, changes in resting energy expenditure and metabolic hormones are linked to the severity of menstrual disturbances, such as luteal-phase defects and amenorrhea.

Even small decreases in energy availability can lead to significant menstrual issues, highlighting the critical relationship between energy balance and reproductive health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Severity of energy-related menstrual disturbances increases in proportion to indices of energy conservation in exercising women. De Souza, MJ., Lee, DK., VanHeest, JL., et al.[2013]

Athletes with menstrual dysfunction (MD) spent significantly more hours in a catabolic state compared to eumenorrheic athletes, despite having similar 24-hour energy availability and balance, indicating a potential risk for metabolic disturbances.

Within-day energy deficiency in MD athletes was linked to lower resting metabolic rate and estradiol levels, as well as higher cortisol levels, suggesting that energy balance may impact hormonal health and metabolism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Within-day energy deficiency and reproductive function in female endurance athletes. Fahrenholtz, IL., Sjödin, A., Benardot, D., et al.[2018]

Amenorrhoea in female athletes is often a sign of low energy availability and should not be considered normal, as it can lead to serious health issues like poor bone density and growth problems, especially during adolescence.

Addressing amenorrhoea requires a comprehensive approach involving screening for energy availability and collaboration among healthcare professionals to effectively treat the underlying causes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amenorrhoea in adolescent female athletes. Ackerman, KE., Misra, M.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11637835/

Study on the correlation between energy availability and ... There were differences in EA between female college athletes with eumenorrhea and SMD. EA was negatively correlated with the occurrence of SMD.

2. academic.oup.com academic.oup.com/nutritionreviews/article/83/3/e866/7713894

Effect of the Menstrual Cycle on Energy Intake: A Systematic ... Energy intake was found to be greater in the LP compared with the FP, providing insight into the effect of the menstrual cycle on energy intake.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34164675/

Randomised controlled trial of the effects of increased energy ... A modest increase in daily energy intake (330 ± 65 kcal/day; 18 ± 4%) is sufficient to induce menstrual recovery in exercising women with Oligo/Amen.

4. withpower.com withpower.com/trial/phase-menstruation-disturbances-7-2024-4e7e1?condition=&query=Estradiol&overallStatus=Recruiting&hasNoPlacebo=false

Energy Availability for Menstrual Irregularities (FAST Trial) The Timing of Energy Availability treatment is unique because it focuses on adjusting the timing and amount of energy intake to improve menstrual function, ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2451865418301297

Rationale and study design of an intervention of increased ... The overall purpose of this study was to evaluate the effects of 12 months of increased energy intake on energetic status, menstrual status, and bone health ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10251302/

Dietary energy intake across the menstrual cycle: a narrative ... Dietary energy intake was 23% greater in the luteal phase when comparing weekend intakes, but there was no evidence of a difference in phase- ...

7. mdpi.com mdpi.com/2072-6643/15/20/4457

Considerations of Low Carbohydrate Availability (LCA) to ... The purpose of this narrative review is to identify health and performance consequences associated with LCA in female endurance athletes.

8. bmjopensem.bmj.com bmjopensem.bmj.com/content/11/3/e002769

UEFA consensus statement on menstrual cycle tracking in ... The consensus underscores that while current evidence linking menstrual cycle phases to performance or injury risk remains inconclusive, ...