Inosine Energy Expenditure Study

Study Overview
=================
Brief Summary
-----------------
Investigators want to test whether the intake of the nucleoside inosine increases the human energy expenditure. Inosine occurs as a metabolic intermediate in the human body and is sometimes taken as a dietary supplement by athletes. For this purpose, investigators will measure the basal metabolic rate by indirect calorimetry. Study participants will then take inosine dissolved in water or placebo and energy expenditure will be assessed again.

Official Title
-----------------
Randomized Cross-over Trial to Investigate the Effect of Inosine on Human Energy Expenditure

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Dietary Supplement: Inosine
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male volunteers BMI between 18-27 kg/m2 Age between 18 and 40 years Exclusion Criteria: Chronic concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, diabetes mellitus), Known or suspected non-compliance, drug or alcohol abuse, Inability to follow the procedures of the study Participation in another study with investigational drug within the 30 days preceding and during the present study, Previous enrolment into the current study, Enrolment of the investigator, his/her family members, employees and other dependent persons, Thyroid disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inosine<br>2 grams of inosine dissolved in 250 ml of tap water | Dietary Supplement: Inosine<br>* 2 grams of inosine dissolved in 250 ml water taken by mouth<br>|
| Placebo Comparator: Water<br>250 ml of tap water only | Other: Placebo<br>* 250 ml water taken by mouth<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| resting energy expenditure after Inosine | resting energy expenditure (REE) assessed by indirect calorimetry after oral intake of two grams of inosine as compared to placebo | one hour after oral intake of inosine | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in energy expenditure | - Difference in EE between baseline measurement and measurement one hour after administration of inosine or control, respectively, at each study visit. | one hour after oral intake of inosine | 
| Change in Respiratory Quotient | - Respiratory quotient (RQ) as an indicator of substrate oxidation one hour after oral intake of two grams of inosine | one hour after oral intake of inosine | 
| Serum inosine level | Serum inosine levels after ingestion of inosine | 0 hours, 1 hour, 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Energy expenditure, metabolism, inosine