Influence of Low Energy Availability on Skeletal Muscle and Cardiovascular Health

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.

Conditions

• Diet; Deficiency
• Exercise Intervention

Interventions

OTHER

Diet intervention - caloric restriction

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

OTHER

Exercise intervention

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

OTHER

Diet intervention - Energy balance

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

Sponsors & Collaborators

• University of Copenhagen

  collaborator OTHER

• University of Southern Denmark

  collaborator OTHER

• University of Aarhus

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

30 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-03-01

Primary Completion

2022-07-01

Completion

2023-06-16

Countries

• Denmark

Study Locations