Clinical trial NCT04821076: Influence of Low Energy Availability on Skeletal Muscle and Cardiovascular Health
Official title: Influence of Low Energy Availability on Performance and Health in Trained and Recreationally Active Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet; Deficiency
Exercise Intervention
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: University of Southern Denmark
First posted: 2021-03-29
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Energy balance group vs. energy restriction
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Changes in muscle protein synthesis
timeFrame: 10 days of diet+exercise intervention
Secondary outcomes:
measure: Markers of muscle protein synthesis and breakdown
timeFrame: before and after 10 days of diet+exercise intervention
measure: Muscle glycogen and lipid levels
timeFrame: before and after 10 days of diet+exercise intervention
measure: Sarcoplasmic reticulum function
timeFrame: before and after 10 days of diet+exercise intervention
measure: Macrophage content in adipose tissue
timeFrame: before and after 10 days of diet+exercise intervention
measure: Adipocyte area and cell size in adipose tissue
timeFrame: before and after 10 days of diet+exercise intervention
measure: Expression of fat oxidative proteins in adipose tissue
timeFrame: before and after 10 days of diet+exercise intervention
measure: Maximal isometric and dynamic muscle strength
timeFrame: before and after 10 days of diet+exercise intervention and 2 days of energybalance
measure: Maximal vertical jump height
timeFrame: before and after 10 days of diet+exercise intervention and 2 days of energybalance
measure: Repeated sprint ability
timeFrame: before and after 10 days of diet+exercise intervention and 2 days of energybalance
measure: 4-minute time trial performance
timeFrame: before and after 10 days of diet+exercise intervention and 2 days of energybalance
measure: Sex hormone levels
timeFrame: During the course of the whole intervention period (18 days)
measure: Cortisol Levels
timeFrame: During the course of the whole intervention period (18 days)
measure: Inflammatory levels
timeFrame: before and after 10 days of diet+exercise intervention and 2 days of energybalance
measure: Bone turnover levels
timeFrame: before and after 10 days of diet+exercise intervention and 2 days of energybalance
measure: Electrocardiogram - Qt interval
timeFrame: before and after 10 days of diet+exercise intervention and 2 days of energybalance
measure: Flow mediated vasodilation
timeFrame: before and after 10 days of diet+exercise intervention and 2 days of energybalance
measure: Resting metabolic rate
timeFrame: before and after 10 days of diet+exercise intervention and 2 days of energybalance
measure: Body composition
timeFrame: before and after 10 days of diet+exercise intervention and 2 days of energybalance
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University, Department for Public Health, Section for Sport Science
Study officials:
References: