Inosine Energy Expenditure Study

NCT04476238 | Completed

• 1 other identifier: 2020-01026
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Energy expenditure; metabolism; inosine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in energy expenditure

  one hour after oral intake of inosine

• Change in Respiratory Quotient

  one hour after oral intake of inosine

• Serum inosine level

  0 hours, 1 hour, 2 hours

Study Arms (2)

Inosine

EXPERIMENTAL

2 grams of inosine dissolved in 250 ml of tap water

Dietary Supplement: Inosine

Water

PLACEBO COMPARATOR

250 ml of tap water only

Other: Placebo

Interventions

Inosine DIETARY_SUPPLEMENT

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

Inosine

Placebo OTHER

250 ml water taken by mouth

Water

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male volunteers
• BMI between 18-27 kg/m2
• Age between 18 and 40 years

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel, Department of Endocrinology

Basel, Canton of Basel-City, 4031, Switzerland

Location

MeSH Terms

Interventions

Inosine

Intervention Hierarchy (Ancestors)

Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 20, 2020
• Study Start: February 28, 2022
• Primary Completion: December 31, 2022
• Study Completion: April 30, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)