Healthy VolunteersInoBATNCT04476238
Inosine Energy Expenditure Study
A study testing Inosine in people with Healthy Volunteers, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Inosine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteSwitzerland
- Study dates
- 28 Feb 2022to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers
- BMI between 18-27 kg/m2
- Age between 18 and 40 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel, Department of Endocrinology
Basel, Canton of Basel-City, 4031
About this study
Official title: 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.
- Conditions
- Healthy Volunteers
- Being tested
- Inosine, Placebo
- Keywords
- Energy expenditure, metabolism, inosine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InosineDietary supplement
2 grams of inosine dissolved in 250 ml water taken by mouth
PlaceboOther
250 ml water taken by mouth
| Study group | Role | What they receive |
|---|---|---|
| Inosine | Experimental | 2 grams of inosine dissolved in 250 ml of tap water Receives: Dietary Supplement: Inosine |
| Water | Placebo comparator | 250 ml of tap water only Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one hour after oral intake of inosine
Secondary outcomes (3)
Change in energy expenditure
- Difference in EE between baseline measurement and measurement one hour after administration of inosine or control, respectively, at each study visit.
Measured: one hour after oral intake of inosine
Change in Respiratory Quotient
- Respiratory quotient (RQ) as an indicator of substrate oxidation one hour after oral intake of two grams of inosine
Measured: one hour after oral intake of inosine
Serum inosine level
Serum inosine levels after ingestion of inosine
Measured: 0 hours, 1 hour, 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start28 Feb 2022
- Primary completion31 Dec 2022
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04476238
- Sponsor's protocol ID
- 2020-01026
- Acronym
- InoBAT
- Status last verified
- Sep 2023
- First submitted
- 14 Jul 2020
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Cross-over Trial to Investigate the Effect of Inosine on Human Energy Expenditure
- ClinicalTrials.gov ID
- NCT04476238
- Acronym / sponsor ID
- InoBAT / 2020-01026
- Conditions
- Healthy Volunteers
- Keywords
- Energy expenditure, metabolism, inosine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 20 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inosine | Experimental | Dietary Supplement: Inosine2 grams of inosine dissolved in 250 ml of tap water |
| Water | Placebo comparator | Other: Placebo250 ml of tap water only |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male volunteers
- BMI between 18-27 kg/m2
- Age between 18 and 40 years
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inosine2 grams of inosine dissolved in 250 ml water taken by mouth | Dietary supplement | Inosine |
| Placebo250 ml water taken by mouth | Other | Water |
Primary outcome
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
3 secondary outcomes
Change in energy expenditure
Time frame: one hour after oral intake of inosine
Change in Respiratory Quotient
Time frame: one hour after oral intake of inosine
Serum inosine level
Time frame: 0 hours, 1 hour, 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inosine in people with Healthy Volunteers, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
resting energy expenditure after Inosine (time frame: one hour after oral intake of inosine). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023; AzTrials last refreshed its copy on 27 Oct 2026.