Skip to main content
OpenTrials
Completed

NCT Number: NCT04821076

Influence of Low Energy Availability on Skeletal Muscle and Cardiovascular Health

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diet; Deficiency Exercise Intervention Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University, Department for Public Health, Section for Sport Science

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet intervention - caloric restriction

Other

Energy restriction is set to 25 kcal / kg fat-free mass

Exercise intervention

Other

Exercise will consist of supervised resistance training, interval training and moderate intensity cycling

Diet intervention - Energy balance

Other

Energy balance is set to 50 kcal / kg fat-free mass

Primary outcomes

  1. Changes in muscle protein synthesis

    Time frame: 10 days of diet+exercise intervention

Secondary outcomes

  1. Markers of muscle protein synthesis and breakdown

    Time frame: before and after 10 days of diet+exercise intervention

  2. Muscle glycogen and lipid levels

    Time frame: before and after 10 days of diet+exercise intervention

  3. Sarcoplasmic reticulum function

    Time frame: before and after 10 days of diet+exercise intervention

  4. Macrophage content in adipose tissue

    Time frame: before and after 10 days of diet+exercise intervention

  5. Adipocyte area and cell size in adipose tissue

    Time frame: before and after 10 days of diet+exercise intervention

  6. Expression of fat oxidative proteins in adipose tissue

    Time frame: before and after 10 days of diet+exercise intervention

  7. Maximal isometric and dynamic muscle strength

    Time frame: before and after 10 days of diet+exercise intervention and 2 days of energybalance

  8. Maximal vertical jump height

    Time frame: before and after 10 days of diet+exercise intervention and 2 days of energybalance

  9. Repeated sprint ability

    Time frame: before and after 10 days of diet+exercise intervention and 2 days of energybalance

  10. 4-minute time trial performance

    Time frame: before and after 10 days of diet+exercise intervention and 2 days of energybalance

  11. Sex hormone levels

    Time frame: During the course of the whole intervention period (18 days)

  12. Cortisol Levels

    Time frame: During the course of the whole intervention period (18 days)

  13. Inflammatory levels

    Time frame: before and after 10 days of diet+exercise intervention and 2 days of energybalance

  14. Bone turnover levels

    Time frame: before and after 10 days of diet+exercise intervention and 2 days of energybalance

  15. Electrocardiogram - Qt interval

    Time frame: before and after 10 days of diet+exercise intervention and 2 days of energybalance

  16. Flow mediated vasodilation

    Time frame: before and after 10 days of diet+exercise intervention and 2 days of energybalance

  17. Resting metabolic rate

    Time frame: before and after 10 days of diet+exercise intervention and 2 days of energybalance

  18. Body composition

    Time frame: before and after 10 days of diet+exercise intervention and 2 days of energybalance

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • University of Copenhagen
  • University of Southern Denmark

Registry information

Official study title

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

Acronym: LEA

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Mar 29, 2021
Registry last updated
May 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.