Influence of Low Energy Availability on Skeletal Muscle and Cardiovascular Health

NCT ID: NCT04821076

Last Updated: 2024-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2023-06-16

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Energy balance

Group Type: ACTIVE_COMPARATOR

Diet intervention - Energy balance

Intervention Type: OTHER

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

Energy restriction

Group Type: EXPERIMENTAL

Diet intervention - caloric restriction

Intervention Type: OTHER

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

Energy balance + exercise

Group Type: ACTIVE_COMPARATOR

Exercise intervention

Intervention Type: OTHER

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

Diet intervention - Energy balance

Intervention Type: OTHER

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

Energy restriction + exercise

Group Type: EXPERIMENTAL

Diet intervention - caloric restriction

Intervention Type: OTHER

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

Exercise intervention

Intervention Type: OTHER

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

Interventions

Diet intervention - caloric restriction

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

Intervention Type: OTHER

Exercise intervention

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

Intervention Type: OTHER

Diet intervention - Energy balance

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Copenhagen

OTHER

Sponsor Role: collaborator

University of Southern Denmark

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Aarhus University, Department for Public Health, Section for Sport Science

Aarhus, , Denmark

Countries

Denmark

Other Identifiers

LEA

Identifier Type: -

Identifier Source: org_study_id