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

NCT06290479 | Completed

• 1 other identifier: 20358
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Water Intake

Keywords

Hydration; Drinking habits; Flavored water

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (1)

• Blood Biomarkers

  Measured at baseline and at the end of the 12-week study period

Study Arms (3)

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.

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.

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.

Interventions

Air Up® Peach Pod DIETARY_SUPPLEMENT

Participants in this arm will use the air up® drinking system with a peach-flavored pod.

Air Up® Peach Pod

Air Up® Orangeade Pod DIETARY_SUPPLEMENT

Participants in this arm will use the air up® drinking system with an orangeade-flavored pod.

Air Up® Orangeade Pod

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• air up GmbH: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masking: Triple (Participant, Care Provider, Investigator)
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator)

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: March 4, 2024
• Study Start: February 15, 2024
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: July 19, 2024

Record last verified: 2024-07

Locations

US (1)