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Circulating Levels of Irisin in Healthy Young Subjects (IRISSAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01986530
Recruitment Status : Completed
First Posted : November 18, 2013
Last Update Posted : January 22, 2015
Sponsor:
Information provided by (Responsible Party):
Athanasios D. Anastasilakis, 424 General Military Hospital

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.

Condition or disease Intervention/treatment
Healthy Subjects Dietary Supplement: Boost Other: Aerobic exercise

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.

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Study Type : Observational
Actual Enrollment : 122 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : November 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


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

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



Primary Outcome Measures :
  1. Irisin [ Time Frame: 1 day ]
    After a standardized dinner and an overnight fast, a blood sample will be obtained the next morning.

  2. 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

  3. 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.

  4. 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.

  5. 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.


Secondary Outcome Measures :
  1. Irisin associates [ Time Frame: 1 day ]
    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

  2. serum adipokines [ Time Frame: 1 day ]
    After a standardized dinner and an overnight fast, a blood sample for adiponectin and leptin will be obtained the next morning.


Biospecimen Retention:   Samples Without DNA
Serum


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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Participants will be healthy volunteers of both sexes recruited from the Greek Military Medical School personnel, Thessaloniki, Greece.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01986530


Locations
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Greece
424 General Military Hospital
Thessaloniki, Greece, 56429
Sponsors and Collaborators
424 General Military Hospital
Investigators
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Principal Investigator: Athanasios D Anastasilakis, MD, PhD 424 General Military Hospital
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Athanasios D. Anastasilakis, Consultant of Endocrinology, 424 General Military Hospital
ClinicalTrials.gov Identifier: NCT01986530    
Other Study ID Numbers: SSAS-1-MANTZ
424-IRIS ( Other Identifier: 424MHTH-1453/28-01-13 )
First Posted: November 18, 2013    Key Record Dates
Last Update Posted: January 22, 2015
Last Verified: January 2015
Keywords provided by Athanasios D. Anastasilakis, 424 General Military Hospital:
irisin
adiponectin
leptin
lean body mass
fat mass