Increased Calorie Intake to Reverse Energy Deficiency in Exercising Women: Impact on Bone and Menstrual Cyclicity
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Menstrual Irregularity |
Behavioral: EAMD+Calories |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | "REFUEL" Active Women's Study II: Increased Caloric Intake to Reverse Energy Deficiency in Exercising Women: Impact on Bone and Menstrual Cyclicity |
- Reproductive hormones [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Metabolic hormones [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Metabolic bone markers [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Bone mineral density [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Eating Disorder Inventory-2 (EDI-2) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Three Factor Eating Questionnaire [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Enrollment: | 233 |
| Study Start Date: | September 2006 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: EAMD+Calories
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
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.
|
|
No Intervention: EAMD Control
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
This group contains exercising women with regular, ovulatory menstrual cycles. this group is instructed to maintain body weight and exercise and eating habits.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00392873
| United States, Pennsylvania | |
| Women's Health and Exercise Laboratories, The Pennsylvania State University | |
| University Park, Pennsylvania, United States, 16802 | |
| Principal Investigator: | Mary Jane De Souza, Ph.D. | Penn State University |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00392873 History of Changes |
| Other Study ID Numbers: | 15353 |
| Study First Received: | October 25, 2006 |
| Last Updated: | October 31, 2014 |
| Health Authority: | United States: Federal Government |
Keywords provided by Penn State University:
|
Amenorrhea Energy deficiency Resting energy expenditure |
Bone metabolism Bone mineral density Exercise |
ClinicalTrials.gov processed this record on February 25, 2015