Influence of Low Energy Availability on Skeletal Muscle and Cardiovascular Health (LEA)

May 8, 2024 updated by: University of Aarhus

Influence of Low Energy Availability on Performance and Health in Trained and Recreationally Active Women

The project is designed as a randomized controlled intervention trial in which 60 young trained (n = 30) (Population A) and recreationally active (n = 30) women (Population B) with regular menstruation are divided into four groups. Population A will receive a low-calorie diet + exercise or an energy balanced diet + exercise over 10 days. Population B will receive a low-calorie diet without exercise, or an energy balanced diet over 10 days. The participants are matched in pairs based on training history and randomized. Before the diet period, the groups will undergo a 6-day control period, during which all participants must take an energy-balanced diet (± training). After the 10 days of the diet intervention period, the groups will receive an energy-balanced diet for 2 days. Before, during, and after the trial period, participants will perform performance tests. In addition, 3 muscle biopsies, 2 adipose biopsies, blood samples, urine samples will be taken during the period, as well as resting metabolic rate, electrocardiogram, flow-mediated vasodilation, and body composition over the trial period. Muscle protein synthesis rate will be measured over the period using stable isotope technique, which includes ingestion of heavy water (D2O) and collection of saliva samples daily (days 0 to 16). The primary measurement parameter is changes in muscle protein synthesis rate.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Aarhus University, Department for Public Health, Section for Sport Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • age 18-30
  • BMI 18.5-30
  • Regular training at least 4 times a week and a maximum of 10 times a week (≥1 times strength training, ≥1 times endurance training / interval training or interval-based sports

Exclusion Criteria:

  • • Irregular menstruation within the last 6 months (shorter end 24 days or longer end 35 days cycle)

    • Used hormonal contraception within the last 3 months for the trial.
    • Injuries / pain in the lower body, which prevents participation in intense strength training
    • Medication consumption that may affect protein metabolism and inflammatory parameters.
    • Diabetes
    • Smoking
    • Unstable weight / major weight loss (weight fluctuations of more than 5 kg in the last six months)
    • Do not eat animal products
    • Eating disorder
    • Pregnancy
    • Blood donor within the last month
    • Cannot read or understand Danish

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Energy balance
Other: Diet intervention - Energy balance
Energy balance is set to 50 kcal / kg fat-free mass
Experimental: Energy restriction
Other: Diet intervention - caloric restriction
Energy restriction is set to 25 kcal / kg fat-free mass
Active Comparator: Energy balance + exercise
Other: Diet intervention - Energy balance
Energy balance is set to 50 kcal / kg fat-free mass
Other: Exercise intervention
Exercise will consist of supervised resistance training, interval training and moderate intensity cycling
Experimental: Energy restriction + exercise
Other: Diet intervention - caloric restriction
Energy restriction is set to 25 kcal / kg fat-free mass
Other: Exercise intervention
Exercise will consist of supervised resistance training, interval training and moderate intensity cycling

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Changes in muscle protein synthesis
Time Frame: 10 days of diet+exercise intervention
10 days of diet+exercise intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Markers of muscle protein synthesis and breakdown
Time Frame: before and after 10 days of diet+exercise intervention
before and after 10 days of diet+exercise intervention
Muscle glycogen and lipid levels
Time Frame: before and after 10 days of diet+exercise intervention
before and after 10 days of diet+exercise intervention
Sarcoplasmic reticulum function
Time Frame: before and after 10 days of diet+exercise intervention
before and after 10 days of diet+exercise intervention
Macrophage content in adipose tissue
Time Frame: before and after 10 days of diet+exercise intervention
before and after 10 days of diet+exercise intervention
Adipocyte area and cell size in adipose tissue
Time Frame: before and after 10 days of diet+exercise intervention
before and after 10 days of diet+exercise intervention
Expression of fat oxidative proteins in adipose tissue
Time Frame: before and after 10 days of diet+exercise intervention
before and after 10 days of diet+exercise intervention
Maximal isometric and dynamic muscle strength
Time Frame: before and after 10 days of diet+exercise intervention and 2 days of energybalance
before and after 10 days of diet+exercise intervention and 2 days of energybalance
Maximal vertical jump height
Time Frame: before and after 10 days of diet+exercise intervention and 2 days of energybalance
before and after 10 days of diet+exercise intervention and 2 days of energybalance
Repeated sprint ability
Time Frame: before and after 10 days of diet+exercise intervention and 2 days of energybalance
before and after 10 days of diet+exercise intervention and 2 days of energybalance
4-minute time trial performance
Time Frame: before and after 10 days of diet+exercise intervention and 2 days of energybalance
before and after 10 days of diet+exercise intervention and 2 days of energybalance
Sex hormone levels
Time Frame: During the course of the whole intervention period (18 days)
During the course of the whole intervention period (18 days)
Cortisol Levels
Time Frame: During the course of the whole intervention period (18 days)
During the course of the whole intervention period (18 days)
Inflammatory levels
Time Frame: before and after 10 days of diet+exercise intervention and 2 days of energybalance
before and after 10 days of diet+exercise intervention and 2 days of energybalance
Bone turnover levels
Time Frame: before and after 10 days of diet+exercise intervention and 2 days of energybalance
before and after 10 days of diet+exercise intervention and 2 days of energybalance
Electrocardiogram - Qt interval
Time Frame: before and after 10 days of diet+exercise intervention and 2 days of energybalance
before and after 10 days of diet+exercise intervention and 2 days of energybalance
Flow mediated vasodilation
Time Frame: before and after 10 days of diet+exercise intervention and 2 days of energybalance
before and after 10 days of diet+exercise intervention and 2 days of energybalance
Resting metabolic rate
Time Frame: before and after 10 days of diet+exercise intervention and 2 days of energybalance
before and after 10 days of diet+exercise intervention and 2 days of energybalance
Body composition
Time Frame: before and after 10 days of diet+exercise intervention and 2 days of energybalance
before and after 10 days of diet+exercise intervention and 2 days of energybalance

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Aarhus

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Copenhagen
University of Southern Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 16, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 29, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LEA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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