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

Primary Purpose

Menstrual Irregularity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

EAMD+Calories

About this trial

This is an interventional treatment trial for Menstrual Irregularity focused on measuring Amenorrhea, Energy deficiency, Resting energy expenditure, Bone metabolism, Bone mineral density, Exercise

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Women's Health and Exercise Laboratories, The Pennsylvania State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

EAMD+Calories

EAMD Control

Heathy Control

Arm Description

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.

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.

This group contains exercising women with regular, ovulatory menstrual cycles. this group is instructed to maintain body weight and exercise and eating habits.

Outcomes

Primary Outcome Measures

Reproductive hormones

Metabolic hormones

Metabolic bone markers

Bone mineral density

Secondary Outcome Measures

Eating Disorder Inventory-2 (EDI-2)

Three Factor Eating Questionnaire

Full Information

NCT ID

NCT00392873

First Posted

October 25, 2006

Last Updated

May 3, 2017

Sponsor

Penn State University

Collaborators

United States Department of Defense

1. Study Identification

Unique Protocol Identification Number

NCT00392873

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

September 2006 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Penn State University

Collaborators

United States Department of Defense

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Menstrual Irregularity

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

233 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EAMD+Calories

Arm Type

Experimental

Arm Description

Arm Title

EAMD Control

Arm Type

No Intervention

Arm Description

Arm Title

Heathy Control

Arm Type

No Intervention

Arm Description

This group contains exercising women with regular, ovulatory menstrual cycles. this group is instructed to maintain body weight and exercise and eating habits.

Intervention Type

Behavioral

Intervention Name(s)

EAMD+Calories

Intervention Description

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.

Primary Outcome Measure Information:

Title

Reproductive hormones

Time Frame

1 year

Title

Metabolic hormones

Time Frame

1 year

Title

Metabolic bone markers

Time Frame

1 year

Title

Bone mineral density

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Eating Disorder Inventory-2 (EDI-2)

Time Frame

1 year

Title

Three Factor Eating Questionnaire

Time Frame

1 year

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mary Jane De Souza, Ph.D.

Organizational Affiliation

Penn State University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Women's Health and Exercise Laboratories, The Pennsylvania State University

City

University Park

State/Province

Pennsylvania

ZIP/Postal Code

16802

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

35170727

Citation

De Souza MJ, Ricker EA, Mallinson RJ, Allaway HCM, Koltun KJ, Strock NCA, Gibbs JC, Kuruppumullage Don P, Williams NI. Bone mineral density in response to increased energy intake in exercising women with oligomenorrhea/amenorrhea: the REFUEL randomized controlled trial. Am J Clin Nutr. 2022 Jun 7;115(6):1457-1472. doi: 10.1093/ajcn/nqac044.

Results Reference

derived

PubMed Identifier

34164675

Citation

De Souza MJ, Mallinson RJ, Strock NCA, Koltun KJ, Olmsted MP, Ricker EA, Scheid JL, Allaway HC, Mallinson DJ, Kuruppumullage Don P, Williams NI. Randomised controlled trial of the effects of increased energy intake on menstrual recovery in exercising women with menstrual disturbances: the 'REFUEL' study. Hum Reprod. 2021 Jul 19;36(8):2285-2297. doi: 10.1093/humrep/deab149.

Results Reference

derived

PubMed Identifier

30896746

Citation

Southmayd EA, Williams NI, Mallinson RJ, De Souza MJ. Energy Deficiency Suppresses Bone Turnover in Exercising Women With Menstrual Disturbances. J Clin Endocrinol Metab. 2019 Aug 1;104(8):3131-3145. doi: 10.1210/jc.2019-00089.

Results Reference

derived

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

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