Increased Calorie Intake to Reverse Energy Deficiency in Exercising Women: Impact on Bone and Menstrual Cyclicity

Study Overview
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Brief Summary
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The purpose of this study is to examine the effects of increased food intake on the menstrual cycle and bone health in physically active women who have irregular or absent menstrual cycles. This study will examine whether a 12 month period of increased food intake will cause menstrual cycles to resume and help bones get stronger.

Detailed Description
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Low levels of estrogen found in physically active, premenopausal women with irregular or absent menstrual periods is likely caused by insufficient energy (calorie) intake compared to energy expenditure. Premenopausal women with menstrual disturbances and amenorrhea suffer from reductions in bone mineral density, particularly in the lumbar spine. Bone loss observed in amenorrheic women may be serious enough to result in osteoporotic fractures, but is also associated with a high prevalence of stress fractures. Increased calorie intake should help improve energy status, menstrual status, and bone health. Comparison: Premenopausal women with irregular or absent menstrual periods will be assigned to either receive additional calories or serve as controls. A group of premenopausal women with normal menstrual periods will also be used for comparison.

Official Title
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REFUEL Active Women's Study II: Increased Caloric Intake to Reverse Energy Deficiency in Exercising Women: Impact on Bone and Menstrual Cyclicity

Conditions
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Menstrual Irregularity

Intervention / Treatment
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* Behavioral: EAMD+Calories


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for Ovulatory Control Volunteers: 18-35 years BMI 16-25 kg/m2 At least 2 hr/wk of aerobic exercise Gynecological age >/= 5 years Weight stable (+/- 2 kg) last 6 months History of regular menses for 6 months Inclusion Criteria for Women with Irregular or Absent Menses: 18-35 years BMI 16-25 kg/m2 At least 3 hr/wk of aerobic exercise Gynecological age >/= 5 years Weight stable (+/- 2 kg) last 6 months No menses within past 3 months or 6 or less menses in last 12 months Low to normal bone mass (L1-L4 Z score </=0) Exclusion Criteria for all participants: Hormonal contraceptives in last 6 months Smoking currently Current clinical diagnosis of an eating disorder Use of medications incompatible with measurement of reproductive or metabolic hormones, including thyroid medications that may interfere with any of the study outcomes. Dietary habits incompatible with prescribed diet for study Any metabolic, reproductive or bone disease Sedentary individuals with less than 120 minutes (2 hrs) of activity per week

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EAMD+Calories<br>This group contains women with exercise-associated menstrual disturbances (EAMD) and receives an intervention of increased caloric intake during the 12-month intervention. The targeted increase in caloric intake is 20-30% of baseline energy expenditure. | Behavioral: EAMD+Calories<br>* During the 12 month intervention, volunteers in the Increased calorie intake group will follow a modified dietary plan designed to achieve and maintain a target level of 20-30% above their previously determined baseline, in an effort to achieve a chronic energy surplus of +20-30% over their baseline energy requirements.<br>|
| No Intervention: EAMD Control<br>This group contains women with exercise-associated menstrual disturbances (EAMD) and undergoes the same procedures as the EAMD+Calories group. However, this group is instructed to maintain exercise and eating habits. | |
| No Intervention: Heathy Control<br>This group contains exercising women with regular, ovulatory menstrual cycles. this group is instructed to maintain body weight and exercise and eating habits. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reproductive hormones |  | 1 year | 
| Metabolic hormones |  | 1 year | 
| Metabolic bone markers |  | 1 year | 
| Bone mineral density |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eating Disorder Inventory-2 (EDI-2) |  | 1 year | 
| Three Factor Eating Questionnaire |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone metabolism, Amenorrhea, Energy deficiency, Resting energy expenditure, Bone mineral density, Exercise