Influence of Low Energy Availability on Skeletal Muscle and Cardiovascular Health

NCT04821076 — Not applicable, Completed, 30 participants, University of Aarhus

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

Registry	NCT04821076, acronym LEA
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	30 (Actual)
Sponsor	University of Aarhus (Other); collaborators: University of Copenhagen, University of Southern Denmark
Conditions	Diet; Deficiency, Exercise Intervention
Interventions	Diet intervention - caloric restriction, Exercise intervention, Diet intervention - Energy balance (Other)
Dates	start 2021-03-01, primary completion 2022-07-01, completion 2023-06-16, first posted 2021-03-29, last updated 2024-05-09
Locations	1 site in Denmark

-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.

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+Arms and interventions

Arm	Type	Interventions
Energy balance	Active comparator	Other: Diet intervention - Energy balance
Energy restriction	Experimental	Other: Diet intervention - caloric restriction
Energy balance + exercise	Active comparator	Other: Exercise intervention; Other: Diet intervention - Energy balance
Energy restriction + exercise	Experimental	Other: Diet intervention - caloric restriction; Other: Exercise intervention

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

+Outcome measures

Primary outcomes

Changes in muscle protein synthesis [10 days of diet+exercise intervention]

Secondary outcomes

Markers of muscle protein synthesis and breakdown [before and after 10 days of diet+exercise intervention]
Muscle glycogen and lipid levels [before and after 10 days of diet+exercise intervention]
Sarcoplasmic reticulum function [before and after 10 days of diet+exercise intervention]
Macrophage content in adipose tissue [before and after 10 days of diet+exercise intervention]
Adipocyte area and cell size in adipose tissue [before and after 10 days of diet+exercise intervention]
Expression of fat oxidative proteins in adipose tissue [before and after 10 days of diet+exercise intervention]
Maximal isometric and dynamic muscle strength [before and after 10 days of diet+exercise intervention and 2 days of energybalance]
Maximal vertical jump height [before and after 10 days of diet+exercise intervention and 2 days of energybalance]
Repeated sprint ability [before and after 10 days of diet+exercise intervention and 2 days of energybalance]
4-minute time trial performance [before and after 10 days of diet+exercise intervention and 2 days of energybalance]
Sex hormone levels [During the course of the whole intervention period (18 days)]
Cortisol Levels [During the course of the whole intervention period (18 days)]
Inflammatory levels [before and after 10 days of diet+exercise intervention and 2 days of energybalance]
Bone turnover levels [before and after 10 days of diet+exercise intervention and 2 days of energybalance]
Electrocardiogram - Qt interval [before and after 10 days of diet+exercise intervention and 2 days of energybalance]
Flow mediated vasodilation [before and after 10 days of diet+exercise intervention and 2 days of energybalance]
Resting metabolic rate [before and after 10 days of diet+exercise intervention and 2 days of energybalance]
Body composition [before and after 10 days of diet+exercise intervention and 2 days of energybalance]

+Eligibility

Sex: Female, ages: 18 Years to 30 Years, accepts 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

+Locations (1)

Facility	City	Country	Status
Aarhus University, Department for Public Health, Section for Sport Science	Aarhus	Denmark