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Completed

NCT Number: NCT04476238

Inosine Energy Expenditure Study

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Basel, Department of Endocrinology

Basel, Canton of Basel-City, 4031, Switzerland

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Inosine

Dietary Supplement

2 grams of inosine dissolved in 250 ml water taken by mouth

Placebo

Other

250 ml water taken by mouth

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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

  3. Serum inosine level

    Time frame: 0 hours, 1 hour, 2 hours

    Serum inosine levels after ingestion of inosine

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: InoBAT

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jul 20, 2020
Registry last updated
Sep 28, 2023

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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