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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00392873
Enrollment
233
Registered
2006-10-26
Start date
2006-09-30
Completion date
2014-12-31
Last updated
2017-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menstrual Irregularity

Keywords

Amenorrhea, Energy deficiency, Resting energy expenditure, Bone metabolism, Bone mineral density, Exercise

Brief 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.

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.

Interventions

BEHAVIORALEAMD+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

United States Department of Defense
CollaboratorFED
Penn State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Reproductive hormones1 year
Metabolic hormones1 year
Metabolic bone markers1 year
Bone mineral density1 year

Secondary

MeasureTime frame
Eating Disorder Inventory-2 (EDI-2)1 year
Three Factor Eating Questionnaire1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 12, 2026