Inosine Energy Expenditure Study

Healthy Volunteers Clinical Trial

— InoBAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04476238
• Other study ID #: 2020-01026
• Status: Completed
• Phase: N/A
• Start date: February 28, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: September 2023
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: April 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Dietary Supplement:
• Inosine
2 grams of inosine dissolved in 250 ml water taken by mouth

Other:
• Placebo
250 ml water taken by mouth

Locations

Country	Name	City	State
Switzerland	University Hospital Basel, Department of Endocrinology	Basel	BS

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Serum inosine level	Serum inosine levels after ingestion of inosine	0 hours, 1 hour, 2 hours