InoBAT: Inosine Energy Expenditure Study

• Sponsor: University Hospital, Basel, Switzerland (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04476238
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 11.1
• Patients Per Site Per Month: 0.7

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 Disease	Intervention/Treatment	Phase
Healthy Volunteers	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
• Actual Study Start Date: Feb 28, 2022
• Anticipated Primary Completion Date: Jun 1, 2022
• Anticipated Study Completion Date: Feb 1, 2023

Arms and Interventions

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

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

	Site	City	State	Country	Postal Code
1	University Hospital Basel, Department of Endocrinology	Basel	BS	Switzerland	4031

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: Mar 15, 2022
• Last Verified: Mar 1, 2022

• 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: Energy expenditure; metabolism; inosine

Study Results

No Results Posted as of Mar 15, 2022