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

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:

MedlinePlus related topics: Menstruation

U.S. FDA Resources

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
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


Ages Eligible for Study:	18 Years to 35 Years (Adult)
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

United States Department of Defense

Investigators


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

More Information


ClinicalTrials.gov Identifier:	NCT00392873 History of Changes
Other Study ID Numbers:	15353
Study First Received:	October 25, 2006
Last Updated:	May 6, 2015
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 September 27, 2016