Inosine Energy Expenditure Study (InoBAT)

September 26, 2023 updated by: University Hospital, Basel, Switzerland

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • BS
      • Basel, BS, Switzerland, 4031
        • University Hospital Basel, Department of Endocrinology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inosine
2 grams of inosine dissolved in 250 ml of tap water
Dietary supplement: Inosine
2 grams of inosine dissolved in 250 ml water taken by mouth
Placebo Comparator: Water
250 ml of tap water only
Other: Placebo
250 ml water taken by mouth

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
resting energy expenditure after Inosine
Time Frame: one hour after oral intake of 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
Time Frame: one hour after oral intake of inosine
- 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
Time Frame: one hour after oral intake of inosine
- 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
Time Frame: 0 hours, 1 hour, 2 hours
Serum inosine levels after ingestion of inosine
0 hours, 1 hour, 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2022

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

April 30, 2023

Study Registration Dates

First Submitted

July 14, 2020

First Submitted That Met QC Criteria

July 14, 2020

First Posted (Actual)

July 20, 2020

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2020-01026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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