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

Primary Purpose

Diet; Deficiency, Exercise Intervention

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Diet intervention - caloric restriction
Exercise intervention
Diet intervention - Energy balance
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diet; Deficiency

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Aarhus University, Department for Public Health, Section for Sport ScienceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

Energy balance

Energy restriction

Energy balance + exercise

Energy restriction + exercise

Arm Description

Outcomes

Primary Outcome Measures

Changes in muscle protein synthesis

Secondary Outcome Measures

Markers of muscle protein synthesis and breakdown
Muscle glycogen and lipid levels
Sarcoplasmic reticulum function
Macrophage content in adipose tissue
Adipocyte area and cell size in adipose tissue
Expression of fat oxidative proteins in adipose tissue
Maximal isometric and dynamic muscle strength
Maximal vertical jump height
Repeated sprint ability
4-minute time trial performance
Sex hormone levels
Cortisol Levels
Inflammatory levels
Bone turnover levels
Electrocardiogram - Qt interval
Flow mediated vasodilation
Resting metabolic rate
Body composition

Full Information

First Posted
March 24, 2021
Last Updated
November 16, 2022
Sponsor
University of Aarhus
Collaborators
University of Copenhagen, University of Southern Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT04821076
Brief Title
Influence of Low Energy Availability on Skeletal Muscle and Cardiovascular Health
Acronym
LEA
Official Title
Influence of Low Energy Availability on Performance and Health in Trained and Recreationally Active Women
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
University of Copenhagen, University of Southern Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diet; Deficiency, Exercise Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Energy balance group vs. energy restriction
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Energy balance
Arm Type
Active Comparator
Arm Title
Energy restriction
Arm Type
Experimental
Arm Title
Energy balance + exercise
Arm Type
Active Comparator
Arm Title
Energy restriction + exercise
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Diet intervention - caloric restriction
Intervention Description
Energy restriction is set to 25 kcal / kg fat-free mass
Intervention Type
Other
Intervention Name(s)
Exercise intervention
Intervention Description
Exercise will consist of supervised resistance training, interval training and moderate intensity cycling
Intervention Type
Other
Intervention Name(s)
Diet intervention - Energy balance
Intervention Description
Energy balance is set to 50 kcal / kg fat-free mass
Primary Outcome Measure Information:
Title
Changes in muscle protein synthesis
Time Frame
10 days of diet+exercise intervention
Secondary Outcome Measure Information:
Title
Markers of muscle protein synthesis and breakdown
Time Frame
before and after 10 days of diet+exercise intervention
Title
Muscle glycogen and lipid levels
Time Frame
before and after 10 days of diet+exercise intervention
Title
Sarcoplasmic reticulum function
Time Frame
before and after 10 days of diet+exercise intervention
Title
Macrophage content in adipose tissue
Time Frame
before and after 10 days of diet+exercise intervention
Title
Adipocyte area and cell size in adipose tissue
Time Frame
before and after 10 days of diet+exercise intervention
Title
Expression of fat oxidative proteins in adipose tissue
Time Frame
before and after 10 days of diet+exercise intervention
Title
Maximal isometric and dynamic muscle strength
Time Frame
before and after 10 days of diet+exercise intervention and 2 days of energybalance
Title
Maximal vertical jump height
Time Frame
before and after 10 days of diet+exercise intervention and 2 days of energybalance
Title
Repeated sprint ability
Time Frame
before and after 10 days of diet+exercise intervention and 2 days of energybalance
Title
4-minute time trial performance
Time Frame
before and after 10 days of diet+exercise intervention and 2 days of energybalance
Title
Sex hormone levels
Time Frame
During the course of the whole intervention period (18 days)
Title
Cortisol Levels
Time Frame
During the course of the whole intervention period (18 days)
Title
Inflammatory levels
Time Frame
before and after 10 days of diet+exercise intervention and 2 days of energybalance
Title
Bone turnover levels
Time Frame
before and after 10 days of diet+exercise intervention and 2 days of energybalance
Title
Electrocardiogram - Qt interval
Time Frame
before and after 10 days of diet+exercise intervention and 2 days of energybalance
Title
Flow mediated vasodilation
Time Frame
before and after 10 days of diet+exercise intervention and 2 days of energybalance
Title
Resting metabolic rate
Time Frame
before and after 10 days of diet+exercise intervention and 2 days of energybalance
Title
Body composition
Time Frame
before and after 10 days of diet+exercise intervention and 2 days of energybalance

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Aarhus University, Department for Public Health, Section for Sport Science
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mette Hansen, PhD
Phone
+4551666551
Email
mhan@ph.au.dk

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Influence of Low Energy Availability on Skeletal Muscle and Cardiovascular Health

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