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

University of Aarhus

Status: Completed

Conditions: Exercise Intervention; Diet; Deficiency

Treatments: Other: Diet intervention - caloric restriction; Other: Exercise intervention; Other: Diet intervention - Energy balance

Study type: Interventional

Funder types: Other

Identifiers

NCT04821076

LEA

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: Female

Ages: 18 to 30 years old

Volunteers: 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 4 patient groups

Energy balance

Active Comparator group

Treatment:

Other: Diet intervention - Energy balance

Energy restriction

Experimental group

Treatment:

Other: Diet intervention - caloric restriction

Energy balance + exercise

Active Comparator group

Treatment:

Other: Diet intervention - Energy balance

Other: Exercise intervention

Energy restriction + exercise

Experimental group

Treatment:

Other: Exercise intervention

Other: Diet intervention - caloric restriction