Healthy NutritionCTR025NCT04937491
Detection of Minor Changes in Fluid Volume or Tonicity in Healthy Volunteers.
An observational study of Healthy Nutrition, run by Mode Sensors AS at 1 site in Norway.
Trial summary
This study is aimed at detecting minor changes in hydration volume and tonicity. We will use healthy students of both sexes who will ingest fluids and nutrition that should lead to specific changes in both intracellular and extracellular volumes. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Nutrition
- What is being tested?
- New medical device (ReBalans)
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- 20 May 2021to 31 May 2023
- Phase
- Observational
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult healthy volunteers (students), 20 years or older.
Who may be able to join
- Healthy volunteer
Who cannot join
- Kidney disease,
- neurological,
- heart or endocrine disease,
- hypertension.
- Eating disorder
Trial locations and contacts
1 site in 1 country.
About this study
This study is aimed at detecting minor changes in hydration volume and tonicity. We will use healthy students of both sexes who will ingest fluids and nutrition that should lead to specific changes in both intracellular and extracellular volumes. The protocol is based on laboratory exercises previously carried out at The Arctic University of Norway (UiT).
- Conditions
- Healthy Nutrition
- Being tested
- New medical device (ReBalans)
- Keywords
- dehyration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New medical device (ReBalans)Device
Body worn, battery powered bioimpedance measuring patch device.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Adult healthy volunteers (students). Intervention 1: Intake of water (2% of body weight) Intervention 2: Intake of sports drink (2% of body weight) Intervention 3: Intake of soya saus (salt): 10 ml (equal to 8 g salt) Intervention 4: Intake of 90 g sugar (jelly figures) Receives: Device: New medical device (ReBalans) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to detect tonicity or volume change
Accurately depict each of the four interventions with a sensitivity better than 0.9.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start20 May 2021
- Primary completion30 Dec 2022 (estimated)
- Study completion31 May 2023 (estimated)
Why it stopped: Due to covid-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy NutritionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mode Sensors AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Tromso
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04937491
- Sponsor's protocol ID
- CTR025 HYDRA TROMSØ
- Acronym
- CTR025
- Status last verified
- Jul 2022
- First submitted
- 16 Jun 2021
- Last updated
- 12 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Minor Changes in Fluid Volume or Tonicity in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT04937491
- Acronym / sponsor ID
- CTR025 / CTR025 HYDRA TROMSØ
- Conditions
- Healthy Nutrition
- Keywords
- dehyration
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Due to covid-19
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mode Sensors ASIndustry (pharma, biotech, devices)
- Collaborators
- University of Tromso
- Study start
- 20 May 2021 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 24 Jun 2021 (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.
This study is aimed at detecting minor changes in hydration volume and tonicity. We will use healthy students of both sexes who will ingest fluids and nutrition that should lead to specific changes in both intracellular and extracellular volumes. The protocol is based on laboratory exercises previously carried out at The Arctic University of Norway (UiT).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Device: New medical device (ReBalans)Adult healthy volunteers (students). Intervention 1: Intake of water (2% of body weight) Intervention 2: Intake of sports drink (2% of body weight) Intervention 3: Intake of soya saus (salt): 10 ml (equal to 8 g salt) Intervention 4: Intake of 90 g sugar (jelly figures) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult healthy volunteers (students), 20 years or older.
Key inclusion criteria (1 listed)
- Healthy volunteer
Key exclusion criteria (5 listed)
- Kidney disease,
- neurological,
- heart or endocrine disease,
- hypertension.
- Eating disorder
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 |
|---|---|---|
| New medical device (ReBalans)Body worn, battery powered bioimpedance measuring patch device. | Device | Healthy volunteers |
Primary outcome
Ability to detect tonicity or volume change
Time frame: 1 week
Accurately depict each of the four interventions with a sensitivity better than 0.9.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
Related trials for Healthy Nutrition
RecruitingPhase 1
A Study to Learn How Different Forms of the Study Medicine Called Berobenatide is Taken up Into the Blood in Adults With Overweight or Obesity
Overweight and/or Obesity, Healthy Participants
Not yet recruitingPhase 1
A Phase I Clinical Trial of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of UBT48128 Tablets in Healthy Participants
Overweight , Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Active, not recruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08653944 in Otherwise Healthy Chinese Adults With Overweight or Obesity
Overweight, Obesity
Recruiting
Nutrition Outcomes Using a Randomized Intervention Via Smartphone on Dietary Habits
Healthy Adult Participants, Mindful Eating Intervention
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?
An observational study of Healthy Nutrition, run by Mode Sensors AS at 1 site in Norway.
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 1 inclusion and 5 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: paused, as of the sponsor's last update on 12 Jul 2022. 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 Norway. 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. 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?
Results are not available in the source record.
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?
Ability to detect tonicity or volume change (time frame: 1 week). 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 12 Jul 2022.