Influence of Low Energy Availability on Skeletal Muscle and Cardiovascular Health

NCT04821076 | Completed

• 1 other identifier: LEA
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Changes in muscle protein synthesis

  10 days of diet+exercise intervention

Secondary Outcomes (18)

• Markers of muscle protein synthesis and breakdown

  before and after 10 days of diet+exercise intervention

• Muscle glycogen and lipid levels

  before and after 10 days of diet+exercise intervention

• Sarcoplasmic reticulum function

  before and after 10 days of diet+exercise intervention

• Macrophage content in adipose tissue

  before and after 10 days of diet+exercise intervention

• Adipocyte area and cell size in adipose tissue

  before and after 10 days of diet+exercise intervention

Study Arms (4)

Energy balance

ACTIVE COMPARATOR

Other: Diet intervention - Energy balance

Energy restriction

EXPERIMENTAL

Other: Diet intervention - caloric restriction

Energy balance + exercise

ACTIVE COMPARATOR

Other: Exercise intervention; Other: Diet intervention - Energy balance

Energy restriction + exercise

EXPERIMENTAL

Other: Diet intervention - caloric restriction; Other: Exercise intervention

Interventions

Diet intervention - caloric restriction OTHER

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

Energy restriction; Energy restriction + exercise

Exercise intervention OTHER

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

Energy balance + exercise; Energy restriction + exercise

Diet intervention - Energy balance OTHER

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

Energy balance; Energy balance + exercise

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• University of Copenhagen: collaborator
• University of Southern Denmark: collaborator

Study Sites (1)

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

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Energy balance group vs. energy restriction

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: March 29, 2021
• Study Start: March 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: June 16, 2023
• Last Updated: May 9, 2024

Record last verified: 2024-05

Locations

DK (1)