InoBAT: Inosine Energy Expenditure Study

Sponsor
University Hospital, Basel, Switzerland (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04476238
Collaborator
(none)
8
Enrollment
2
Arms
12
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Dietary Supplement: Inosine
  • Other: Placebo
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
8 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
Randomized Cross-over Trial to Investigate the Effect of Inosine on Human Energy Expenditure
Anticipated Study Start Date :
Feb 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

ArmIntervention/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

Outcome Measures

Primary Outcome Measures

  1. resting energy expenditure after Inosine [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

Secondary Outcome Measures

  1. Change in energy expenditure [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.

  2. Change in Respiratory Quotient [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

  3. Serum inosine level [0 hours, 1 hour, 2 hours]

    Serum inosine levels after ingestion of inosine

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital, Basel, Switzerland

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT04476238
Other Study ID Numbers:
  • 2020-01026
First Posted:
Jul 20, 2020
Last Update Posted:
Nov 17, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Basel, Switzerland

Study Results

No Results Posted as of Nov 17, 2021