Detection of Minor Changes in Fluid Volume or Tonicity in Healthy Volunteers.

NCT ID: NCT04937491

Last Updated: 2022-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

SUSPENDED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-20

Study Completion Date

2023-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Nutrition

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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)

New medical device (ReBalans)

Intervention Type DEVICE

Body worn, battery powered bioimpedance measuring patch device.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

New medical device (ReBalans)

Body worn, battery powered bioimpedance measuring patch device.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\- Healthy volunteer

Exclusion Criteria

* Kidney disease,
* neurological,
* heart or endocrine disease,
* hypertension.
* Eating disorder
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Tromso

OTHER

Sponsor Role collaborator

Mode Sensors AS

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Arctic University of Norway

Tromsø, , Norway

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CTR025 HYDRA TROMSØ

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Body Water Content Sensor
NCT00643721 TERMINATED