LEA: Influence of Low Energy Availability on Skeletal Muscle and Cardiovascular Health

Sponsor
University of Aarhus (Other)
Overall Status
Recruiting
CT.gov ID
NCT04821076
Collaborator
University of Copenhagen (Other), University of Southern Denmark (Other)
60
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4
33
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Diet intervention - caloric restriction
  • Other: Exercise intervention
  • Other: Diet intervention - Energy balance
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Energy balance group vs. energy restrictionEnergy balance group vs. energy restriction
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Influence of Low Energy Availability on Performance and Health in Trained and Recreationally Active Women
Actual Study Start Date :
Mar 1, 2021
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Energy balance

Other: Diet intervention - Energy balance
Energy balance is set to 50 kcal / kg fat-free mass

Experimental: Energy restriction

Other: Diet intervention - caloric restriction
Energy restriction is set to 25 kcal / kg fat-free mass

Active Comparator: Energy balance + exercise

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

Experimental: Energy restriction + exercise

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

Outcome Measures

Primary Outcome Measures

  1. Changes in muscle protein synthesis [10 days of diet+exercise intervention]

Secondary Outcome Measures

  1. Markers of muscle protein synthesis and breakdown [before and after 10 days of diet+exercise intervention]

  2. Muscle glycogen and lipid levels [before and after 10 days of diet+exercise intervention]

  3. Sarcoplasmic reticulum function [before and after 10 days of diet+exercise intervention]

  4. Macrophage content in adipose tissue [before and after 10 days of diet+exercise intervention]

  5. Adipocyte area and cell size in adipose tissue [before and after 10 days of diet+exercise intervention]

  6. Expression of fat oxidative proteins in adipose tissue [before and after 10 days of diet+exercise intervention]

  7. Maximal isometric and dynamic muscle strength [before and after 10 days of diet+exercise intervention and 2 days of energybalance]

  8. Maximal vertical jump height [before and after 10 days of diet+exercise intervention and 2 days of energybalance]

  9. Repeated sprint ability [before and after 10 days of diet+exercise intervention and 2 days of energybalance]

  10. 4-minute time trial performance [before and after 10 days of diet+exercise intervention and 2 days of energybalance]

  11. Sex hormone levels [During the course of the whole intervention period (18 days)]

  12. Cortisol Levels [During the course of the whole intervention period (18 days)]

  13. Inflammatory levels [before and after 10 days of diet+exercise intervention and 2 days of energybalance]

  14. Bone turnover levels [before and after 10 days of diet+exercise intervention and 2 days of energybalance]

  15. Electrocardiogram - Qt interval [before and after 10 days of diet+exercise intervention and 2 days of energybalance]

  16. Flow mediated vasodilation [before and after 10 days of diet+exercise intervention and 2 days of energybalance]

  17. Resting metabolic rate [before and after 10 days of diet+exercise intervention and 2 days of energybalance]

  18. Body composition [before and after 10 days of diet+exercise intervention and 2 days of energybalance]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 30 Years
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Aarhus University, Department for Public Health, Section for Sport Science Aarhus Denmark 8000

Sponsors and Collaborators

  • University of Aarhus
  • University of Copenhagen
  • University of Southern Denmark

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT04821076
Other Study ID Numbers:
  • LEA
First Posted:
Mar 29, 2021
Last Update Posted:
May 18, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 18, 2022