HealthyNCT02478658
Circulatory Levels of Irisin in Response to Acute Resistance Training
A study testing exercise training in people with Healthy, run by Texas Tech University at 1 site in United States.
Trial summary
Study the circulatory levels of irisin in response to one session of high-intensity resistance training in a group of healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Dec 2015
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants between 18 and 30 years old
- Males and Females
- Healthy
Who cannot join
- Participants with known health problems such as cardiovascular, pulmonary or metabolic disease will be excluded.
- Pregnant females will be excluded from the study.
- Any adults found taking medications that affect endocrine or cardiovascular function will also be excluded from the study.
- Individuals found to be less than 110 pounds will also be excluded due to the collection of blood during this study.
- Participants that exercise more than three times per week or strength train more than twice per week will be excluded.
- Individuals that have poor venous access or have expressed a fear of needles or having blood taken will also be excluded.
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- Cigarette smoking (current or those who quit within the previous 6 months
- Hypertension
- Overweight and obese
- Pre-diabetics
Trial locations and contacts
1 site in 1 country.
United States1 site
Exercise and Sport Sciences Building
Lubbock, Texas, 79423
About this study
Study the circulatory levels of irisin in response to one session of high-intensity resistance training in a group of healthy subjects.
Read the detailed description
Objective: The purpose of this study is to study the circulating levels of irisin in response to acute high-intensity resistance training in a group of healthy young adults.
Sample: The sample will be comprised of adult men and women unpaid volunteers between the ages of 18 and 30. We will recruit 44 participants.
Pre- screening assessments: Informed consent, PAR-Q, Medical History and Exercise History will be used to determine health status and prior exercise experience. Menstrual cycle log will be required for female participants.
Pre-Intervention assessments (baseline):
- Anthropometric measurements and Body Composition: Height, triceps, thigh and calf skinfolds, biceps, thigh, hip, waist, and calf circumferences will be measured. Dual-energy x-ray absorptiometry (DEXA) will be performed to obtain body composition.
- Blood-related variables. Baseline glucose, lactate and hematocrit will be obtained from all participants prior to intervention. Lactate and Hematocrit will be obtained pre-intervention and post-intervention, and within 1 min post workout.
Irisin will be obtained from blood samples at baseline, during and after the training session. Irisin will be measured via a commercial enzyme-linked immunosorbent assay.
- Cardiopulmonary and Strength Fitness Testing. Cardiopulmonary fitness will be determined via maximum oxygen consumption testing. One maximum repetition (1-RM) will be used to assess the muscular fitness.
- Dietary Controls. Each participant will complete the Food Preference Questionnaire. In addition, the Automated Self-Administered 24-hour Recall (ASA24) will be collected for the day prior to the session.
- Familiarization. Participant will be instructed on the muscle conditioning techniques used for strength training so that the techniques can be mastered. The rate of perceived exertion (RPE) scale will also be used for familiarization during these sessions.
- Spontaneous Physical Activity: Daily activity level for 7 days will be collected.
Intervention: Resistance training will consist on a circuit training of 3 sets of 7 exercises focused on major muscle groups. Ten repetitions on each circuit at 70% of the maximum capacity will be performed. Acute intervention will consist of one session. Blood will be collected pre-session, at 45 min during the session, and immediately after the acute intervention exposure (post-session).
- Conditions
- Healthy
- Being tested
- exercise training
- Keywords
- irisin, resistance training, physical fitness, Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise trainingOther
high-intensity resistance training
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The acute intervention will consist of 1 session of training following the program:
Resistance Training Exercises. Each participant in the intervention group will perform resistance-training exercises in the form of a circuit. The circuit will consist of 10 repetitions per exercise of 7 exercises: leg press, bent-over row, bench press, squats, dumbbell jump squats with raises, dead-lifts and weighted abdominal crunches, with approximately 30 sec of rest in between each exercise (based on the estimated time needed to move from one position to the next). Initial intensity 6-7 of RPE and ending the set at 9-10. Each participant will move through the circuit 3 times, with 2 to 3 minutes of rest between each round. Receives: Other: exercise training |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum irisin levels
Changes in irisin levels baseline, 45 min (during the training session), and post-training session
Measured: 1 day
Secondary outcomes (7)
Body composition assessment, as measured by DEXA and anthropometry
Body composition at baseline prior to the training session
Measured: 1 day
Lactate levels
Intensity of exercise at the end of the session (post-training session)
Measured: 1 day
Physical Fitness levels as measured by 1 RM (repetition maximum) and Cardio-respiratory maximal test
Physical Fitness levels at baseline prior to the training session
Measured: 1day
Blood Glucose levels
Blood Glucose levels at baseline prior to the training session
Measured: 1 session (1 day)
Diet assessment: 24 hour recall and Food Preference Questionnaire
Dietary habits at baseline prior to the training session
Measured: 1day
Hematocrit concentration
Hematocrit levels at baseline and post-training session
Measured: 1 day
Physical Activity assessment, as measured by Accelerometry.
Quantification of baseline Physical Activity levels at baseline prior to the training session
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study startFeb 2015
- Primary completionOct 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Fernandez del Valle, PhD, Principal investigator, Texas Tech University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02478658
- Sponsor's protocol ID
- 504792A
- Status last verified
- Jul 2019
- First submitted
- 3 Feb 2015
- Last updated
- 25 Jul 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulatory Levels of Irisin in Response to Acute Resistance Training
- ClinicalTrials.gov ID
- NCT02478658
- Acronym / sponsor ID
- 504792A
- Conditions
- Healthy
- Keywords
- irisin, resistance training, physical fitness, Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Texas Tech UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 23 Jun 2015 (estimated)
- 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.
Study the circulatory levels of irisin in response to one session of high-intensity resistance training in a group of healthy subjects.
Detailed description
Objective: The purpose of this study is to study the circulating levels of irisin in response to acute high-intensity resistance training in a group of healthy young adults.
Sample: The sample will be comprised of adult men and women unpaid volunteers between the ages of 18 and 30. We will recruit 44 participants.
Pre- screening assessments: Informed consent, PAR-Q, Medical History and Exercise History will be used to determine health status and prior exercise experience. Menstrual cycle log will be required for female participants.
Pre-Intervention assessments (baseline):
- Anthropometric measurements and Body Composition: Height, triceps, thigh and calf skinfolds, biceps, thigh, hip, waist, and calf circumferences will be measured. Dual-energy x-ray absorptiometry (DEXA) will be performed to obtain body composition.
- Blood-related variables. Baseline glucose, lactate and hematocrit will be obtained from all participants prior to intervention. Lactate and Hematocrit will be obtained pre-intervention and post-intervention, and within 1 min post workout.
Irisin will be obtained from blood samples at baseline, during and after the training session. Irisin will be measured via a commercial enzyme-linked immunosorbent assay.
- Cardiopulmonary and Strength Fitness Testing. Cardiopulmonary fitness will be determined via maximum oxygen consumption testing. One maximum repetition (1-RM) will be used to assess the muscular fitness.
- Dietary Controls. Each participant will complete the Food Preference Questionnaire. In addition, the Automated Self-Administered 24-hour Recall (ASA24) will be collected for the day prior to the session.
- Familiarization. Participant will be instructed on the muscle conditioning techniques used for strength training so that the techniques can be mastered. The rate of perceived exertion (RPE) scale will also be used for familiarization during these sessions.
- Spontaneous Physical Activity: Daily activity level for 7 days will be collected.
Intervention: Resistance training will consist on a circuit training of 3 sets of 7 exercises focused on major muscle groups. Ten repetitions on each circuit at 70% of the maximum capacity will be performed. Acute intervention will consist of one session. Blood will be collected pre-session, at 45 min during the session, and immediately after the acute intervention exposure (post-session).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: exercise trainingThe acute intervention will consist of 1 session of training following the program: Resistance Training Exercises. Each participant in the intervention group will perform resistance-training exercises in the form of a circuit. The circuit will consist of 10 repetitions per exercise of 7 exercises: leg press, bent-over row, bench press, squats, dumbbell jump squats with raises, dead-lifts and weighted abdominal crunches, with approximately 30 sec of rest in between each exercise (based on the estimated time needed to move from one position to the next). Initial intensity 6-7 of RPE and ending the set at 9-10. Each participant will move through the circuit 3 times, with 2 to 3 minutes of rest between each round. |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants between 18 and 30 years old
- Males and Females
- Healthy
Key exclusion criteria (10 listed)
- Participants with known health problems such as cardiovascular, pulmonary or metabolic disease will be excluded.
- Pregnant females will be excluded from the study.
- Any adults found taking medications that affect endocrine or cardiovascular function will also be excluded from the study.
- Individuals found to be less than 110 pounds will also be excluded due to the collection of blood during this study.
- Participants that exercise more than three times per week or strength train more than twice per week will be excluded.
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 |
|---|---|---|
| exercise traininghigh-intensity resistance training | Other | Intervention |
Primary outcome
Serum irisin levels
Time frame: 1 day
Changes in irisin levels baseline, 45 min (during the training session), and post-training session
7 secondary outcomes
Body composition assessment, as measured by DEXA and anthropometry
Time frame: 1 day
Lactate levels
Time frame: 1 day
Physical Fitness levels as measured by 1 RM (repetition maximum) and Cardio-respiratory maximal test
Time frame: 1day
Blood Glucose levels
Time frame: 1 session (1 day)
Diet assessment: 24 hour recall and Food Preference Questionnaire
Time frame: 1day
Hematocrit concentration
Time frame: 1 day
Physical Activity assessment, as measured by Accelerometry.
Time frame: 1 week
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 25 Jul 2019.
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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.
Maria Fernandez del Valle, PhD principal investigator
Texas Tech University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise training in people with Healthy, run by Texas Tech University at 1 site in United States.
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 10 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 25 Jul 2019. 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 United States. 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?
Serum irisin levels (time frame: 1 day). 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 25 Jul 2019.