A Three-Group Study to Examine the Efficacy of the Air up® Drinking System at Improving Hydration and Associated Health Outcomes

February 26, 2024 updated by: air up GmbH
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Willingness to use the system
  • Generally healthy
  • Enjoys the smell of peach or orangeade.

Exclusion Criteria:

  • Silicone allergy
  • IBS, bariatric surgery,
  • pregnancy
  • participation in another clinical study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Air Up® Peach Pod
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.
Dietary supplement: Air Up® Peach Pod
Participants in this arm will use the air up® drinking system with a peach-flavored pod.
Experimental: Air Up® Orangeade Pod
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.
Dietary supplement: Air Up® Orangeade Pod
Participants in this arm will use the air up® drinking system with an orangeade-flavored pod.
No Intervention: Control - Unscented Pod
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Biomarkers
Time Frame: Measured at baseline and at the end of the 12-week study period
Changes in blood biomarkers (Insulin, HbA1c, and Glucose)
Measured at baseline and at the end of the 12-week study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

air up GmbH

Collaborators

Citruslabs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2024

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

February 20, 2024

First Submitted That Met QC Criteria

February 26, 2024

First Posted (Estimated)

March 4, 2024

Study Record Updates

Last Update Posted (Estimated)

March 4, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20358

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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