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Completed

NCT Number: NCT01986530

Circulating Levels of Irisin in Healthy Young Subjects

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.

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Key information

Conditions

Healthy Subjects

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

424 General Military Hospital

Thessaloniki, 56429, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Boost

Dietary Supplement

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

Aerobic Exercise

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

424 General Military Hospital

Other

Registry information

Official study 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

Acronym: IRISSAS

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 18, 2013
Registry last updated
Jan 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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