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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00392873
First Posted: October 26, 2006
Last Update Posted: May 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Mary Jane DeSouza, Penn State University
  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
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

Resource links provided by NLM:


Further study details as provided by Mary Jane DeSouza, Penn State University:

Primary Outcome Measures:
  • Reproductive hormones [ Time Frame: 1 year ]
  • Metabolic hormones [ Time Frame: 1 year ]
  • Metabolic bone markers [ Time Frame: 1 year ]
  • Bone mineral density [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Eating Disorder Inventory-2 (EDI-2) [ Time Frame: 1 year ]
  • Three Factor Eating Questionnaire [ Time Frame: 1 year ]

Enrollment: 233
Study Start Date: September 2006
Study Completion Date: December 2014
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

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00392873


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

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 Submitted: October 25, 2006
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