Circulating Levels of Irisin in Healthy Young Subjects

Healthy Subjects Clinical Trial

— IRISSAS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01986530
• Other study ID #: SSAS-1-MANTZ
• Secondary ID: 424-IRIS
• Status: Completed
• Phase: N/A
• First received: November 9, 2013
• Last updated: January 20, 2015
• Start date: November 2013
• Est. completion date: January 2015

Study information

• Verified date: January 2015
• Source: 424 General Military Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 25 Years

Eligibility

Inclusion Criteria: Healthy volunteers

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

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

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

Locations

Country	Name	City	State
Greece	424 General Military Hospital	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
424 General Military Hospital

Country where clinical trial is conducted

Greece, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Irisin	After a standardized dinner and an overnight fast, a blood sample will be obtained the next morning.	1 day	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	1 day	No
Secondary	serum adipokines	After a standardized dinner and an overnight fast, a blood sample for adiponectin and leptin will be obtained the next morning.	1 day	No