Diet; DeficiencyLEANCT04821076
Influence of Low Energy Availability on Skeletal Muscle and Cardiovascular Health
A study testing Diet intervention - caloric restriction, Exercise intervention and Diet intervention - Energy balance in people with Diet; Deficiency and Exercise Intervention, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diet; Deficiency, Exercise Intervention
- What is being tested?
- Diet intervention - caloric restriction, Exercise intervention and Diet intervention - Energy balance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2021to 16 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- • 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University, Department for Public Health, Section for Sport Science
Aarhus, 8000
About this study
Official title: Influence of Low Energy Availability on Performance and Health in Trained and Recreationally Active Women
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
- Being tested
- Diet intervention - caloric restriction, Exercise intervention, Diet intervention - Energy balance
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet intervention - caloric restrictionOther
Energy restriction is set to 25 kcal / kg fat-free mass
Exercise will consist of supervised resistance training, interval training and moderate intensity cycling
Diet intervention - Energy balanceOther
Energy balance is set to 50 kcal / kg fat-free mass
| Study group | Role | What they receive |
|---|---|---|
| Energy balance | Active comparator | Not described Receives: Other: Diet intervention - Energy balance |
| Energy restriction | Experimental | Not described Receives: Other: Diet intervention - caloric restriction |
| Energy balance + exercise | Active comparator | Not described Receives: Other: Exercise intervention; Other: Diet intervention - Energy balance |
| Energy restriction + exercise | Experimental | Not described Receives: Other: Diet intervention - caloric restriction; Other: Exercise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in muscle protein synthesis
Measured: 10 days of diet+exercise intervention
Secondary outcomes (18)
Markers of muscle protein synthesis and breakdown
Measured: before and after 10 days of diet+exercise intervention
Muscle glycogen and lipid levels
Measured: before and after 10 days of diet+exercise intervention
Sarcoplasmic reticulum function
Measured: before and after 10 days of diet+exercise intervention
Macrophage content in adipose tissue
Measured: before and after 10 days of diet+exercise intervention
Adipocyte area and cell size in adipose tissue
Measured: before and after 10 days of diet+exercise intervention
Expression of fat oxidative proteins in adipose tissue
Measured: before and after 10 days of diet+exercise intervention
Maximal isometric and dynamic muscle strength
Measured: before and after 10 days of diet+exercise intervention and 2 days of energybalance
Maximal vertical jump height
Measured: before and after 10 days of diet+exercise intervention and 2 days of energybalance
Repeated sprint ability
Measured: before and after 10 days of diet+exercise intervention and 2 days of energybalance
4-minute time trial performance
Measured: before and after 10 days of diet+exercise intervention and 2 days of energybalance
Sex hormone levels
Measured: During the course of the whole intervention period (18 days)
Cortisol Levels
Measured: During the course of the whole intervention period (18 days)
Inflammatory levels
Measured: before and after 10 days of diet+exercise intervention and 2 days of energybalance
Bone turnover levels
Measured: before and after 10 days of diet+exercise intervention and 2 days of energybalance
Electrocardiogram - Qt interval
Measured: before and after 10 days of diet+exercise intervention and 2 days of energybalance
Flow mediated vasodilation
Measured: before and after 10 days of diet+exercise intervention and 2 days of energybalance
Resting metabolic rate
Measured: before and after 10 days of diet+exercise intervention and 2 days of energybalance
Body composition
Measured: before and after 10 days of diet+exercise intervention and 2 days of energybalance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start1 Mar 2021
- Primary completion1 Jul 2022
- Study completion16 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet; DeficiencyStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Energy balance group vs. energy restriction
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, University of Southern Denmark
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04821076
- Sponsor's protocol ID
- LEA
- Acronym
- LEA
- Status last verified
- May 2024
- First submitted
- 24 Mar 2021
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Low Energy Availability on Performance and Health in Trained and Recreationally Active Women
- ClinicalTrials.gov ID
- NCT04821076
- Acronym / sponsor ID
- LEA / LEA
- Conditions
- Diet; Deficiency, Exercise Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- University of Copenhagen, University of Southern Denmark
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 16 Jun 2023 (actual)
- First posted
- 29 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- Energy balance group vs. energy restriction
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- • Irregular menstruation within the last 6 months (shorter end 24 days or longer end 35 days cycle)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet intervention - caloric restrictionEnergy restriction is set to 25 kcal / kg fat-free mass | Other | Energy restriction, Energy restriction + exercise |
| Exercise interventionExercise will consist of supervised resistance training, interval training and moderate intensity cycling | Other | Energy balance + exercise, Energy restriction + exercise |
| Diet intervention - Energy balanceEnergy balance is set to 50 kcal / kg fat-free mass | Other | Energy balance, Energy balance + exercise |
Primary outcome
Changes in muscle protein synthesis
Time frame: 10 days of diet+exercise intervention
18 secondary outcomes
Markers of muscle protein synthesis and breakdown
Time frame: before and after 10 days of diet+exercise intervention
Muscle glycogen and lipid levels
Time frame: before and after 10 days of diet+exercise intervention
Sarcoplasmic reticulum function
Time frame: before and after 10 days of diet+exercise intervention
Macrophage content in adipose tissue
Time frame: before and after 10 days of diet+exercise intervention
Adipocyte area and cell size in adipose tissue
Time frame: before and after 10 days of diet+exercise intervention
Expression of fat oxidative proteins in adipose tissue
Time frame: before and after 10 days of diet+exercise intervention
Maximal isometric and dynamic muscle strength
Time frame: before and after 10 days of diet+exercise intervention and 2 days of energybalance
Maximal vertical jump height
Time frame: before and after 10 days of diet+exercise intervention and 2 days of energybalance
Repeated sprint ability
Time frame: before and after 10 days of diet+exercise intervention and 2 days of energybalance
4-minute time trial performance
Time frame: before and after 10 days of diet+exercise intervention and 2 days of energybalance
Sex hormone levels
Time frame: During the course of the whole intervention period (18 days)
Cortisol Levels
Time frame: During the course of the whole intervention period (18 days)
Inflammatory levels
Time frame: before and after 10 days of diet+exercise intervention and 2 days of energybalance
Bone turnover levels
Time frame: before and after 10 days of diet+exercise intervention and 2 days of energybalance
Electrocardiogram - Qt interval
Time frame: before and after 10 days of diet+exercise intervention and 2 days of energybalance
Flow mediated vasodilation
Time frame: before and after 10 days of diet+exercise intervention and 2 days of energybalance
Resting metabolic rate
Time frame: before and after 10 days of diet+exercise intervention and 2 days of energybalance
Body composition
Time frame: before and after 10 days of diet+exercise intervention and 2 days of energybalance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet intervention - caloric restriction, Exercise intervention and Diet intervention - Energy balance in people with Diet; Deficiency and Exercise Intervention, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in muscle protein synthesis (time frame: 10 days of diet+exercise intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.