Influence of Low Energy Availability on Skeletal Muscle and Cardiovascular Health

Exercise Intervention Clinical Trial

— LEA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04821076
• Other study ID #: LEA
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: June 16, 2023

Study information

• Verified date: May 2024
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 16, 2023
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Diet; Deficiency
• Exercise Intervention
• Malnutrition

Intervention

Other:
• Diet intervention - caloric restriction
Energy restriction is set to 25 kcal / kg fat-free mass
• Exercise intervention
Exercise will consist of supervised resistance training, interval training and moderate intensity cycling
• Diet intervention - Energy balance
Energy balance is set to 50 kcal / kg fat-free mass

Locations

Country	Name	City	State
Denmark	Aarhus University, Department for Public Health, Section for Sport Science	Aarhus

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	University of Copenhagen, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

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