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

NCT00392873 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 233

Last updated 2017-05-08

No results posted yet for this study

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.

Conditions

  • Menstrual Irregularity

Interventions

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.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED
  • Penn State University

    lead OTHER

Principal Investigators

  • Mary Jane De Souza, Ph.D. · Penn State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00392873 on ClinicalTrials.gov