Controlled Diet for Reproductive Hormone Levels
(LEAP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how reproductive hormones might change when following a specific diet for five days. Participants will eat an individualized, standardized diet that is either energy-balanced or low in energy. The focus is on females aged 18-30 with regular menstrual cycles and stable weight. The trial does not suit those on hormonal birth control, with polycystic ovary syndrome, or engaged in regular aerobic exercise.
As an unphased study, this trial allows participants to contribute to valuable research on diet and hormone interactions.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that diets with low energy availability (LEA), where the body receives insufficient energy from food, can have mixed effects. In the short term, LEA might cause bodily changes. Studies have found it can affect hormone levels and other health indicators. For instance, lower levels of ferritin, a protein that stores iron, and changes in hormones like estradiol and testosterone may occur. These changes relate to energy intake and can impact health.
Short-term effects, such as those from a few days on such a diet, are usually less serious than long-term effects. Monitoring the body's response is important. Prospective participants in a study involving this type of diet should understand these details to prepare and make informed decisions. Participants are encouraged to ask the trial organizers any questions about safety and expectations.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores how diet can directly influence reproductive hormone levels, an area not deeply explored by current treatment options. While most treatments for hormone imbalances focus on medication or hormone therapy, this study looks at the potential of adjusting energy intake through diet to achieve balance. The unique aspect here is the individualized approach to energy balance, considering fat-free mass, which could lead to more personalized and effective dietary interventions for managing hormone-related conditions. This could open new avenues for non-invasive, lifestyle-based management strategies that are easier to maintain and adjust according to individual needs.
What evidence suggests that this trial's diets could be effective for reproductive hormone levels?
Research has shown that consuming too few calories, known as low energy availability (LEA), can significantly impact reproductive hormones. LEA occurs when calorie intake falls below the body's needs and has been linked to menstrual cycle changes, such as amenorrhea (missing periods for 90 days or more). Some studies suggest that consuming less than 30 calories per kilogram of lean body mass can trigger these hormonal changes. In this trial, participants will follow one of two diet plans: the low energy availability metabolic diet, providing 20 kcal/kg of fat-free mass per day, or the energy balanced metabolic diet, providing 45 kcal/kg of fat-free mass per day. Adequate calorie intake helps maintain stable hormone levels. These findings suggest that the two diet plans in the study might directly influence reproductive hormones due to differences in calorie intake.678910
Who Is on the Research Team?
Ann E Caldwell, PhD
Principal Investigator
University of Colorado Anschutz School of Medicine
Are You a Good Fit for This Trial?
This trial is for women aged 18-30 with a BMI of 18.5-24.9 or 30-45, who have had regular menstrual cycles and stable weight recently. It's not for those on hormonal birth control, pregnant, planning pregnancy soon, diagnosed with PCOS, exercising regularly, or with significant health issues like heart disease or diabetes.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants follow a 5-day individualized, standardized diet at two levels: energy balance and low energy intake
Follow-up
Participants are monitored for changes in reproductive hormones and pituitary function
What Are the Treatments Tested in This Trial?
Interventions
- Individualized, Standardized Diet
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor