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Influence of Low Energy Availability on Skeletal Muscle and Cardiovascular Health

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04821076
Acronym
LEA
Enrollment
30
Registered
2021-03-29
Start date
2021-03-01
Completion date
2023-06-16
Last updated
2024-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diet; Deficiency, Exercise Intervention

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.

Interventions

OTHERDiet intervention - caloric restriction

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

OTHERExercise intervention

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

OTHERDiet intervention - Energy balance

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

Sponsors

University of Copenhagen
CollaboratorOTHER
University of Southern Denmark
CollaboratorOTHER
University of Aarhus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Intervention model description

Energy balance group vs. energy restriction

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 30 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Changes in muscle protein synthesis10 days of diet+exercise intervention

Secondary

MeasureTime frame
Markers of muscle protein synthesis and breakdownbefore and after 10 days of diet+exercise intervention
Muscle glycogen and lipid levelsbefore and after 10 days of diet+exercise intervention
Sarcoplasmic reticulum functionbefore and after 10 days of diet+exercise intervention
Macrophage content in adipose tissuebefore and after 10 days of diet+exercise intervention
Adipocyte area and cell size in adipose tissuebefore and after 10 days of diet+exercise intervention
Maximal isometric and dynamic muscle strengthbefore and after 10 days of diet+exercise intervention and 2 days of energybalance
Maximal vertical jump heightbefore and after 10 days of diet+exercise intervention and 2 days of energybalance
Repeated sprint abilitybefore and after 10 days of diet+exercise intervention and 2 days of energybalance
Expression of fat oxidative proteins in adipose tissuebefore and after 10 days of diet+exercise intervention
Sex hormone levelsDuring the course of the whole intervention period (18 days)
Cortisol LevelsDuring the course of the whole intervention period (18 days)
Inflammatory levelsbefore and after 10 days of diet+exercise intervention and 2 days of energybalance
Bone turnover levelsbefore and after 10 days of diet+exercise intervention and 2 days of energybalance
Electrocardiogram - Qt intervalbefore and after 10 days of diet+exercise intervention and 2 days of energybalance
Flow mediated vasodilationbefore and after 10 days of diet+exercise intervention and 2 days of energybalance
Resting metabolic ratebefore and after 10 days of diet+exercise intervention and 2 days of energybalance
Body compositionbefore and after 10 days of diet+exercise intervention and 2 days of energybalance
4-minute time trial performancebefore and after 10 days of diet+exercise intervention and 2 days of energybalance

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026