NCT04821076: LEA

Influence of Low Energy Availability on Skeletal Muscle and Cardiovascular Health

Completed NA Last updated 9 May 2024

What this trial tests

NA trial testing Diet intervention - caloric restriction in Diet; Deficiency in 30 participants. Completed in 16 June 2023.

Timeline

1 March 2021

Primary endpoint
1 July 2022

16 June 2023

Quick facts

Lead sponsor	University of Aarhus
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	30
Start date	1 March 2021
Primary completion	1 July 2022
Estimated completion	16 June 2023
Sites	1 location across Denmark

Drugs / interventions tested

• Diet intervention - caloric restriction
• Exercise intervention
• Diet intervention - Energy balance

Conditions studied

• Diet; Deficiency — all drugs for Diet; Deficiency →
• Exercise Intervention — all drugs for Exercise Intervention →

Sponsor

University of Aarhus

Who can join

Adults 18 to 30, female only, with Diet; Deficiency or Exercise Intervention. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.