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

May 3, 2017 updated by: Mary Jane DeSouza, Penn State University

"REFUEL" Active Women's Study II: Increased Caloric 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

233

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bone mineral density
Time Frame: 1 year
1 year
Reproductive hormones
Time Frame: 1 year
1 year
Metabolic hormones
Time Frame: 1 year
1 year
Metabolic bone markers
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Eating Disorder Inventory-2 (EDI-2)
Time Frame: 1 year
1 year
Three Factor Eating Questionnaire
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Penn State University

Collaborators

United States Department of Defense

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

October 25, 2006

First Submitted That Met QC Criteria

October 25, 2006

First Posted (Estimate)

October 26, 2006

Study Record Updates

Last Update Posted (Actual)

May 8, 2017

Last Update Submitted That Met QC Criteria

May 3, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15353

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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