Water IntakeNCT06290479
A Three-Group Study to Examine the Efficacy of the Air up® Drinking System at Improving Hydration and Associated Health Outcomes
A study testing Air Up® Peach Pod and Air Up® Orangeade Pod in people with Water Intake, run by air up GmbH at 1 site in United States.
Trial summary
A randomized, controlled trial evaluating the air up® drinking system's impact on hydration and health outcomes. Participants will use air up® with Peach, Orangeade, or unscented pods and their effects on drinking habits, and health outcomes will be assessed over 12 weeks. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Water Intake
- What is being tested?
- Air Up® Peach Pod and Air Up® Orangeade Pod
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2024to 30 Jun 2024
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willingness to use the system
- Generally healthy
- Enjoys the smell of peach or orangeade.
Who cannot join
- Silicone allergy
- IBS, bariatric surgery,
- pregnancy
- participation in another clinical study.
Trial locations and contacts
1 site in 1 country.
About this study
A randomized, controlled trial evaluating the air up® drinking system's impact on hydration and health outcomes. Participants will use air up® with Peach, Orangeade, or unscented pods and their effects on drinking habits, and health outcomes will be assessed over 12 weeks.
- Conditions
- Water Intake
- Being tested
- Air Up® Peach Pod, Air Up® Orangeade Pod
- Keywords
- Hydration, Drinking habits, Flavored water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air Up® Peach PodDietary supplement
Participants in this arm will use the air up® drinking system with a peach-flavored pod.
Air Up® Orangeade PodDietary supplement
Participants in this arm will use the air up® drinking system with an orangeade-flavored pod.
| Study group | Role | What they receive |
|---|---|---|
| Air Up® Peach Pod | Experimental | Participants in this arm will use the air up® drinking system with a peach-flavored pod. The intervention aims to test if the flavored scent encourages increased water intake, which will be assessed by self-reported questionnaires and hydration-related health outcomes over 12 weeks. Receives: Dietary Supplement: Air Up® Peach Pod |
| Air Up® Orangeade Pod | Experimental | Participants in this arm will use the air up® drinking system with an orangeade-flavored pod. Similar to Arm 1, the intervention will assess the impact of the flavored scent on water consumption and health outcomes, using the same methods of evaluation. Receives: Dietary Supplement: Air Up® Orangeade Pod |
| Control - Unscented Pod | No intervention | Participants in this control arm will use the air up® drinking system with an unscented pod. This group will serve as the control to evaluate the effectiveness of the scented pods in comparison to a baseline with no added scent. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hydration Habits and Health Outcomes as Measured by the Water Intake Questionnaire and the Hydration-Related Quality of Life Scale
This measure evaluates changes in participants' hydration habits and health impacts using questionnaires with a 5-point Likert scale.
Measured: 12 weeks
Secondary outcomes (1)
Blood Biomarkers
Changes in blood biomarkers (Insulin, HbA1c, and Glucose)
Measured: Measured at baseline and at the end of the 12-week study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start15 Feb 2024
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Water IntakeStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- air up GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06290479
- Sponsor's protocol ID
- 20358
- Status last verified
- Jul 2024
- First submitted
- 20 Feb 2024
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Three-Group Study to Examine the Efficacy of the Air up® Drinking System at Improving Hydration and Associated Health Outcomes
- ClinicalTrials.gov ID
- NCT06290479
- Acronym / sponsor ID
- 20358
- Conditions
- Water Intake
- Keywords
- Hydration, Drinking habits, Flavored water
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- air up GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 4 Mar 2024 (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.
A randomized, controlled trial evaluating the air up® drinking system's impact on hydration and health outcomes. Participants will use air up® with Peach, Orangeade, or unscented pods and their effects on drinking habits, and health outcomes will be assessed over 12 weeks.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator)
| Arm | Type | Receives |
|---|---|---|
| Air Up® Peach Pod | Experimental | Dietary Supplement: Air Up® Peach PodParticipants in this arm will use the air up® drinking system with a peach-flavored pod. The intervention aims to test if the flavored scent encourages increased water intake, which will be assessed by self-reported questionnaires and hydration-related health outcomes over 12 weeks. |
| Air Up® Orangeade Pod | Experimental | Dietary Supplement: Air Up® Orangeade PodParticipants in this arm will use the air up® drinking system with an orangeade-flavored pod. Similar to Arm 1, the intervention will assess the impact of the flavored scent on water consumption and health outcomes, using the same methods of evaluation. |
| Control - Unscented Pod | No intervention | –Participants in this control arm will use the air up® drinking system with an unscented pod. This group will serve as the control to evaluate the effectiveness of the scented pods in comparison to a baseline with no added scent. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Willingness to use the system
- Generally healthy
- Enjoys the smell of peach or orangeade.
Key exclusion criteria (4 listed)
- Silicone allergy
- IBS, bariatric surgery,
- pregnancy
- participation in another clinical 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 |
|---|---|---|
| Air Up® Peach PodParticipants in this arm will use the air up® drinking system with a peach-flavored pod. | Dietary supplement | Air Up® Peach Pod |
| Air Up® Orangeade PodParticipants in this arm will use the air up® drinking system with an orangeade-flavored pod. | Dietary supplement | Air Up® Orangeade Pod |
Primary outcome
Change in Hydration Habits and Health Outcomes as Measured by the Water Intake Questionnaire and the Hydration-Related Quality of Life Scale
Time frame: 12 weeks
This measure evaluates changes in participants' hydration habits and health impacts using questionnaires with a 5-point Likert scale.
1 secondary outcome
Blood Biomarkers
Time frame: Measured at baseline and at the end of the 12-week study period
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 19 Jul 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Water Intake
Not yet recruiting
Effects of Increased Water Intake on Hormonal Response, Hydration Status, and Physical Function in Low-drinking Older Adults
Dehydrated, Water-Electrolyte Imbalance, Malnutrition, Dehydration (Physiology)
Not yet recruiting
Effects of Hydrogen-rich Water Consumption on Transient Fatigue During an Official Football Match.
Exercise-Induced Fatigue, Football Performance
Active, not recruiting
Water Intake and Weight Control in Older Adults
Overweight and Obesity
Not yet recruiting
Impact of Reducing the Dialysate Flow Rate in Chronic Hemodialysis on Dialysis Quality and Environmental Impact on Water Consumption
Kidney Disease, Chronic
Not yet recruitingObservational study
The Effect of pH Value of Water Consumed During Bowel Preparation Before Colonoscopy on Colon Cleansing
Colonoscopy, Bowel Cleansing
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 Air Up® Peach Pod and Air Up® Orangeade Pod in people with Water Intake, run by air up GmbH at 1 site in United States.
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 4 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 19 Jul 2024. 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 United States. 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?
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?
Change in Hydration Habits and Health Outcomes as Measured by the Water Intake Questionnaire and the Hydration-Related Quality of Life Scale (time frame: 12 weeks). 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 19 Jul 2024.