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

NCT00392873 | Completed DMC

• 1 other identifier: 15353
• Study Type: interventional
• Target: 233
• Locations: 1 country
• Sites: 1

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.

Conditions

Menstrual Irregularity

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Reproductive hormones

  1 year

• Metabolic hormones

  1 year

• Metabolic bone markers

  1 year

• Bone mineral density

  1 year

Secondary Outcomes (2)

• Eating Disorder Inventory-2 (EDI-2)

  1 year

• Three Factor Eating Questionnaire

  1 year

Study Arms (3)

EAMD+Calories

EXPERIMENTAL

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

EAMD Control

NO INTERVENTION

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.

Heathy Control

NO INTERVENTION

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

Interventions

EAMD+Calories 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+Calories

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Penn State University: lead
• United States Department of Defense: collaborator

Study Sites (1)

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

University Park, Pennsylvania, 16802, United States

Location

Related Publications (4)

• Strock NCA, De Souza MJ, Mallinson RJ, Olmsted M, Allaway HCM, O'Donnell E, Plessow F, Williams NI. 12-months of increased dietary intake does not exacerbate disordered eating-related attitudes, stress, or depressive symptoms in women with exercise-associated menstrual disturbances: The REFUEL randomized controlled trial. Psychoneuroendocrinology. 2023 Jun;152:106079. doi: 10.1016/j.psyneuen.2023.106079. Epub 2023 Mar 8.

  PMID: 36947969 DERIVED

• 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.

  PMID: 35170727 DERIVED

• 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.

  PMID: 34164675 DERIVED

• 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.

  PMID: 30896746 DERIVED

MeSH Terms

Conditions

Menstruation Disturbances; Amenorrhea; Motor Activity

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Mary Jane De Souza, Ph.D.

  Penn State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Kinesiology and Physiology

Study Record Dates

• First Submitted: October 25, 2006
• First Posted: October 26, 2006
• Study Start: September 1, 2006
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 8, 2017

Record last verified: 2017-05

Locations

US (1)