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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

233 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Influence of Low Energy Availability on Skeletal Muscle and Cardiovascular Health

NCT04821076

Diet; Deficiency Exercise Intervention

COMPLETED NA

Appetite and Dietary Intake Across the Menstrual Cycle

NCT06327087

Appetitive Behavior Healthy Dietary Habits

RECRUITING

Menstrual Cycle Hormones and Eating Behavior

NCT01407692

Dietary Habits Food Preference

COMPLETED

The Effects of Combined Energy and Carbohydrate Restriction on Exercise Capacity

NCT06381908

Overweight and Obesity

RECRUITING NA

Activity, Adiposity, and Appetite in Adolescents 2

NCT04028921

Obesity Metabolic Disease Insulin Sensitivity

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Menstrual Irregularity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

EAMD+Calories

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

* 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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes