NCT01986530

Brief 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. Furthermore, the circadian and seasonal variation of irisin is largely unknown.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 18, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

January 22, 2015

Status Verified

January 1, 2015

Enrollment Period

1.2 years

First QC Date

November 9, 2013

Last Update Submit

January 20, 2015

Conditions

Healthy Subjects

Keywords

irisinadiponectinleptinlean body massfat mass

Outcome Measures

Primary Outcomes (5)

  • Irisin

    After a standardized dinner and an overnight fast, a blood sample will be obtained the next morning.

    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

    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.

    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.

    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.

    1 day

Secondary Outcomes (2)

  • Irisin associates

    1 day

  • serum adipokines

    1 day

Study Arms (5)

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

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

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.

Interventions

BoostDIETARY_SUPPLEMENT

After an overnight fast, blood samples will be obtained before as well as 30 min after standardized mixed meal ingestion

Boost Subgroup
Aerobic exerciseOTHER

After an overnight fast and rest, blood samples will be obtained before as well as 30 min after aerobic exercise

Aerobic exercise

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Participants will be healthy volunteers of both sexes recruited from the Greek Military Medical School personnel, Thessaloniki, Greece.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

424 General Military Hospital

Thessaloniki, 56429, Greece

Location

Related Publications (5)

  • 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.

    PMID: 24140091BACKGROUND

  • Vamvini 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.

    PMID: 24062354BACKGROUND

  • Polyzos 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.

    PMID: 23664085BACKGROUND

  • Huh 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.

    PMID: 23018146BACKGROUND

  • Anastasilakis 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.

    PMID: 24915120DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Athanasios D Anastasilakis, MD, PhD

    424 General Military Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant of Endocrinology

Study Record Dates

First Submitted

November 9, 2013

First Posted

November 18, 2013

Study Start

November 1, 2013

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

January 22, 2015

Record last verified: 2015-01

Locations

GR(1)