Healthy SubjectsIRISSASNCT01986530
Circulating Levels of Irisin in Healthy Young Subjects
An observational study of Healthy Subjects, run by 424 General Military Hospital at 1 site in Greece.
Trial summary
Irisin, a newly discovered myokine induced in exercise, has potential effects in stimulating adipose tissue browning, fighting obesity and diabetes. No prior study has reported on the role of circulating irisin in healthy individuals in correlation with lean and fat body mass. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Boost and Aerobic exercise
- How many people
- 122 participants
- Where
- 1 siteGreece
- Study dates
- Nov 2013to Jan 2015
- Phase
- Observational
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Participants will be healthy volunteers of both sexes recruited from the Greek Military Medical School personnel, Thessaloniki, Greece.
Who may be able to join
- Exclusion Criteria: i) body mass index (BMI) above 30 or below 20 kg/m2; ii) diseases that could affect muscle or fat homeostasis; iii) medications that could affect muscle or fat homeostasis.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Circulating Irisin in Healthy Young Men and Women and Correlation With Lean Body Mass, Fat Mass and Adipocytokines. Circadian and Seasonal Variation and the Effect of Food Intake and Exercise
Irisin, a newly discovered myokine induced in exercise, has potential effects in stimulating adipose tissue browning, fighting obesity and diabetes. No prior study has reported on the role of circulating irisin in healthy individuals in correlation with lean and fat body mass. Furthermore, the circadian and seasonal variation of irisin is largely unknown.
Read the detailed description
The main aims of this prospective study will be to investigate: 1) circulating irisin levels in healthy, young men and women according to their lean and fat mass; 2) the circadian variations of irisin levels; 3) the seasonal variations of irisin levels.
- Conditions
- Healthy Subjects
- Being tested
- Boost, Aerobic exercise
- Keywords
- irisin, adiponectin, leptin, lean body mass, fat mass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BoostDietary supplement
After an overnight fast, blood samples will be obtained before as well as 30 min after standardized mixed meal ingestion
Aerobic exerciseOther
After an overnight fast and rest, blood samples will be obtained before as well as 30 min after aerobic exercise
| Study group | Role | What they receive |
|---|---|---|
| Healthy individuals | Participants will be healthy volunteers of both sexes recruited from the Greek Military Medical School personnel, Thessaloniki, Greece. | |
| Boost Subgroup | After an overnight fast, 40 participants will be provided a standardized mixed meal in two different quantities (125 ml, n=20 and 250 ml, n=20) and blood samples will be obtained before as well as 30 min after mixed meal ingestion Receives: Dietary Supplement: Boost | |
| Aerobic exercise | After an overnight fast, 20 participants will be subjected to aerobic exercise for 30 min and blood samples will be obtained at baseline and at 30 min Receives: Other: Aerobic exercise | |
| Circadian variation Subgroup | 20 of the participants will be hospitalized and closely monitored for 24 hours. A catheter will be inserted in a vein and blood samples will be obtained every 3 hours through the 24-hour period. | |
| Seasonal variation Subgroup | 20 of the participants will be monitored for one year and blood samples will be obtained every 3 months (at the middle of month January - April - July - October). Subjects will be instructed to maintain their normal exercise routine and dietary habits. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Irisin
After a standardized dinner and an overnight fast, a blood sample will be obtained the next morning.
Measured: 1 day
irisin circadian variation
20 participants will be hospitalized and closely monitored for 24 hours. A catheter will be inserted in a vein and blood samples will be obtained every 3 hours through the 24-hour period
Measured: 1 day
irisin seasonal variation
20 participants will be monitored for one year and blood samples will be obtained every 3 months (at the middle of month January - April - July - October). At the same intervals physical examination and BMI calculation will be conducted. Subjects will be instructed to maintain their normal exercise routine and dietary habits.
Measured: 12 months
Irisin postprandial
A sub-population of 40 participants of the cohort will receive a standardized meal (Boost) in two different quantities (20 participants will receive 125 ml and 20 participants 250 ml). Serum irisin levels will be measured at baseline and 30 min postprandial.
Measured: 1 day
Irisin after excercise
A sub-population of 20 participants of the cohort will be subjected to 30 min of aerobic exercise. Serum irisin levels will be measured at baseline and at 30 min.
Measured: 1 day
Secondary outcomes (2)
Irisin associates
After a standardized dinner and an overnight fast, a blood sample for adiponectin and leptin will be obtained the next morning, and body composition (total body fat mass and bone-free lean mass) will be assessed by BIA. Participants will also be asked to complete a validated questionnaire assessing their diet and exercise habits. Correlations between serum irisin levels and the above parameters will be examined
Measured: 1 day
serum adipokines
After a standardized dinner and an overnight fast, a blood sample for adiponectin and leptin will be obtained the next morning.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- 424 General Military Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Athanasios D. Anastasilakis, 424 General Military Hospital
- Investigators
- Athanasios D Anastasilakis, MD, PhD, Principal investigator, 424 General Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01986530
- Sponsor's protocol ID
- SSAS-1-MANTZ
- Other IDs
- 424-IRIS
- Acronym
- IRISSAS
- Status last verified
- Jan 2015
- First submitted
- 9 Nov 2013
- Last updated
- 22 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Polyzos SA, Kountouras J, Anastasilakis AD, Geladari EV, Mantzoros CS. Irisin in patients with nonalcoholic fatty liver disease. Metabolism. 2014 Feb;63(2):207-17. doi: 10.1016/j.metabol.2013.09.013. Epub 2013 Oct 18.
PubMed 24140091Vamvini MT, Aronis KN, Panagiotou G, Huh JY, Chamberland JP, Brinkoetter MT, Petrou M, Christophi CA, Kales SN, Christiani DC, Mantzoros CS. Irisin mRNA and circulating levels in relation to other myokines in healthy and morbidly obese humans. Eur J Endocrinol. 2013 Oct 21;169(6):829-34. doi: 10.1530/EJE-13-0276. Print 2013 Dec.
PubMed 24062354Polyzos SA, Kountouras J, Shields K, Mantzoros CS. Irisin: a renaissance in metabolism? Metabolism. 2013 Aug;62(8):1037-44. doi: 10.1016/j.metabol.2013.04.008. Epub 2013 May 10. No abstract available.
PubMed 23664085Huh JY, Panagiotou G, Mougios V, Brinkoetter M, Vamvini MT, Schneider BE, Mantzoros CS. FNDC5 and irisin in humans: I. Predictors of circulating concentrations in serum and plasma and II. mRNA expression and circulating concentrations in response to weight loss and exercise. Metabolism. 2012 Dec;61(12):1725-38. doi: 10.1016/j.metabol.2012.09.002. Epub 2012 Sep 25.
PubMed 23018146Anastasilakis AD, Polyzos SA, Saridakis ZG, Kynigopoulos G, Skouvaklidou EC, Molyvas D, Vasiloglou MF, Apostolou A, Karagiozoglou-Lampoudi T, Siopi A, Mougios V, Chatzistavridis P, Panagiotou G, Filippaios A, Delaroudis S, Mantzoros CS. Circulating irisin in healthy, young individuals: day-night rhythm, effects of food intake and exercise, and associations with gender, physical activity, diet, and body composition. J Clin Endocrinol Metab. 2014 Sep;99(9):3247-55. doi: 10.1210/jc.2014-1367. Epub 2014 Jun 10.
PubMed 24915120
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Irisin in Healthy Young Men and Women and Correlation With Lean Body Mass, Fat Mass and Adipocytokines. Circadian and Seasonal Variation and the Effect of Food Intake and Exercise
- ClinicalTrials.gov ID
- NCT01986530
- Acronym / sponsor ID
- IRISSAS / SSAS-1-MANTZ
- Conditions
- Healthy Subjects
- Keywords
- irisin, adiponectin, leptin, lean body mass, fat mass
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- 424 General Military HospitalUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 18 Nov 2013 (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.
Irisin, a newly discovered myokine induced in exercise, has potential effects in stimulating adipose tissue browning, fighting obesity and diabetes. No prior study has reported on the role of circulating irisin in healthy individuals in correlation with lean and fat body mass. Furthermore, the circadian and seasonal variation of irisin is largely unknown.
Detailed description
The main aims of this prospective study will be to investigate: 1) circulating irisin levels in healthy, young men and women according to their lean and fat mass; 2) the circadian variations of irisin levels; 3) the seasonal variations of irisin levels.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthy individuals | – | –Participants will be healthy volunteers of both sexes recruited from the Greek Military Medical School personnel, Thessaloniki, Greece. |
| Boost Subgroup | – | Dietary Supplement: BoostAfter an overnight fast, 40 participants will be provided a standardized mixed meal in two different quantities (125 ml, n=20 and 250 ml, n=20) and blood samples will be obtained before as well as 30 min after mixed meal ingestion |
| Aerobic exercise | – | Other: Aerobic exerciseAfter an overnight fast, 20 participants will be subjected to aerobic exercise for 30 min and blood samples will be obtained at baseline and at 30 min |
| Circadian variation Subgroup | – | –20 of the participants will be hospitalized and closely monitored for 24 hours. A catheter will be inserted in a vein and blood samples will be obtained every 3 hours through the 24-hour period. |
| Seasonal variation Subgroup | – | –20 of the participants will be monitored for one year and blood samples will be obtained every 3 months (at the middle of month January - April - July - October). Subjects will be instructed to maintain their normal exercise routine and dietary habits. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants will be healthy volunteers of both sexes recruited from the Greek Military Medical School personnel, Thessaloniki, Greece.
Key inclusion criteria (1 listed)
- Exclusion Criteria: i) body mass index (BMI) above 30 or below 20 kg/m2; ii) diseases that could affect muscle or fat homeostasis; iii) medications that could affect muscle or fat homeostasis.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| BoostAfter an overnight fast, blood samples will be obtained before as well as 30 min after standardized mixed meal ingestion | Dietary supplement | Boost Subgroup |
| Aerobic exerciseAfter an overnight fast and rest, blood samples will be obtained before as well as 30 min after aerobic exercise | Other | Aerobic exercise |
Primary outcome
Irisin
Time frame: 1 day
After a standardized dinner and an overnight fast, a blood sample will be obtained the next morning.
irisin circadian variation
Time frame: 1 day
20 participants will be hospitalized and closely monitored for 24 hours. A catheter will be inserted in a vein and blood samples will be obtained every 3 hours through the 24-hour period
irisin seasonal variation
Time frame: 12 months
20 participants will be monitored for one year and blood samples will be obtained every 3 months (at the middle of month January - April - July - October). At the same intervals physical examination and BMI calculation will be conducted. Subjects will be instructed to maintain their normal exercise routine and dietary habits.
Irisin postprandial
Time frame: 1 day
A sub-population of 40 participants of the cohort will receive a standardized meal (Boost) in two different quantities (20 participants will receive 125 ml and 20 participants 250 ml). Serum irisin levels will be measured at baseline and 30 min postprandial.
Irisin after excercise
Time frame: 1 day
A sub-population of 20 participants of the cohort will be subjected to 30 min of aerobic exercise. Serum irisin levels will be measured at baseline and at 30 min.
2 secondary outcomes
Irisin associates
Time frame: 1 day
serum adipokines
Time frame: 1 day
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 22 Jan 2015.
- Background: PubMed 24140091Polyzos SA, Kountouras J, Anastasilakis AD, Geladari EV, Mantzoros CS. Irisin in patients with nonalcoholic fatty liver disease. Metabolism. 2014 Feb;63(2):207-17. doi: 10.1016/j.metabol.2013.09.013. Epub 2013 Oct 18.
- Background: PubMed 24062354Vamvini MT, Aronis KN, Panagiotou G, Huh JY, Chamberland JP, Brinkoetter MT, Petrou M, Christophi CA, Kales SN, Christiani DC, Mantzoros CS. Irisin mRNA and circulating levels in relation to other myokines in healthy and morbidly obese humans. Eur J Endocrinol. 2013 Oct 21;169(6):829-34. doi: 10.1530/EJE-13-0276. Print 2013 Dec.
- Background: PubMed 23664085Polyzos SA, Kountouras J, Shields K, Mantzoros CS. Irisin: a renaissance in metabolism? Metabolism. 2013 Aug;62(8):1037-44. doi: 10.1016/j.metabol.2013.04.008. Epub 2013 May 10. No abstract available.
- Background: PubMed 23018146Huh JY, Panagiotou G, Mougios V, Brinkoetter M, Vamvini MT, Schneider BE, Mantzoros CS. FNDC5 and irisin in humans: I. Predictors of circulating concentrations in serum and plasma and II. mRNA expression and circulating concentrations in response to weight loss and exercise. Metabolism. 2012 Dec;61(12):1725-38. doi: 10.1016/j.metabol.2012.09.002. Epub 2012 Sep 25.
- Derived from this study: PubMed 24915120Anastasilakis AD, Polyzos SA, Saridakis ZG, Kynigopoulos G, Skouvaklidou EC, Molyvas D, Vasiloglou MF, Apostolou A, Karagiozoglou-Lampoudi T, Siopi A, Mougios V, Chatzistavridis P, Panagiotou G, Filippaios A, Delaroudis S, Mantzoros CS. Circulating irisin in healthy, young individuals: day-night rhythm, effects of food intake and exercise, and associations with gender, physical activity, diet, and body composition. J Clin Endocrinol Metab. 2014 Sep;99(9):3247-55. doi: 10.1210/jc.2014-1367. Epub 2014 Jun 10.
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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.
Athanasios D Anastasilakis, MD, PhD principal investigator
424 General Military Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Subjects, run by 424 General Military Hospital at 1 site in Greece.
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 1 inclusion and 0 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 22 Jan 2015. 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 Greece. 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?
Irisin (time frame: 1 day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01986530, which also lists 5 linked publications.
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 22 Jan 2015.