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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Menstrual Irregularity	Behavioral: EAMD+Calories	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	233 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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
Study Start Date :	September 2006
Actual Primary Completion Date :	December 2014
Actual Study Completion Date :	December 2014

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Reproductive hormones [ Time Frame: 1 year ]
2. Metabolic hormones [ Time Frame: 1 year ]
3. Metabolic bone markers [ Time Frame: 1 year ]
4. Bone mineral density [ Time Frame: 1 year ]

Secondary Outcome Measures :

1. Eating Disorder Inventory-2 (EDI-2) [ Time Frame: 1 year ]
2. Three Factor Eating Questionnaire [ Time Frame: 1 year ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 35 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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 Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Pennsylvania
Women's Health and Exercise Laboratories, The Pennsylvania State University
University Park, Pennsylvania, United States, 16802

Sponsors and Collaborators

Penn State University

United States Department of Defense

Investigators

Principal Investigator:	Mary Jane De Souza, Ph.D.	Penn State University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Mary Jane DeSouza, Professor of Kinesiology and Physiology, Penn State University
ClinicalTrials.gov Identifier:	NCT00392873 History of Changes
Other Study ID Numbers:	15353
First Posted:	October 26, 2006
Last Update Posted:	May 8, 2017
Last Verified:	May 2017

Keywords provided by Mary Jane DeSouza, Penn State University:

Amenorrhea; Energy deficiency; Resting energy expenditure	Bone metabolism; Bone mineral density; Exercise