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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by:
Penn State University
ClinicalTrials.gov Identifier:
NCT00392873
First received: October 25, 2006
Last updated: October 31, 2014
Last verified: October 2014
  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

Resource links provided by NLM:


Further study details as provided by Penn State University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
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 November 25, 2014