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

Menstrual Irregularity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00392873
• Other study ID #: 15353
• Status: Completed
• Phase: N/A
• First received: October 25, 2006
• Last updated: May 3, 2017
• Start date: September 2006
• Est. completion date: December 2014

Study information

• Verified date: May 2017
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 233
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Menstrual Irregularity

Intervention

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.

Locations

Country	Name	City	State
United States	Women's Health and Exercise Laboratories, The Pennsylvania State University	University Park	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Penn State University	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reproductive hormones		1 year
Primary	Metabolic hormones		1 year
Primary	Metabolic bone markers		1 year
Primary	Bone mineral density		1 year
Secondary	Eating Disorder Inventory-2 (EDI-2)		1 year
Secondary	Three Factor Eating Questionnaire		1 year