Skip to main content
OpenTrials
Completed

NCT Number: NCT00392873

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Menstrual Irregularity Amenorrhea Behavior Menstruation Disturbances Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Women's Health and Exercise Laboratories, The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EAMD+Calories

Behavioral

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.

Primary outcomes

  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 outcomes

  1. Eating Disorder Inventory-2 (EDI-2)

    Time frame: 1 year

  2. Three Factor Eating Questionnaire

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2014
Study completion
2014
First posted
Oct 26, 2006
Registry last updated
May 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.