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

NCT04937491 | Suspended DMC

• 1 other identifier: CTR025 HYDRA TROMSØ
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. The protocol is based on laboratory exercises previously carried out at The Arctic University of Norway (UiT).

Conditions

Healthy Nutrition

Keywords

dehyration

Outcome Measures

Primary Outcomes (1)

• Ability to detect tonicity or volume change

  Accurately depict each of the four interventions with a sensitivity better than 0.9.

  1 week

Study Arms (1)

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)

Device: New medical device (ReBalans)

Interventions

New medical device (ReBalans) DEVICE

Body worn, battery powered bioimpedance measuring patch device.

Healthy volunteers

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult healthy volunteers (students), 20 years or older.

You may qualify if:

• \- Healthy volunteer

You may not qualify if:

• Kidney disease,
• neurological,
• heart or endocrine disease,
• hypertension.
• Eating disorder

Sponsors & Collaborators

• Mode Sensors AS: lead
• University of Tromso: collaborator

Study Sites (1)

Arctic University of Norway

Tromsø, 9019, Norway

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum: sodium, albumin, carbamide, glucose, creatinine and haemoglobin

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: June 24, 2021
• Study Start: May 20, 2021
• Primary Completion: December 30, 2022
• Study Completion: May 31, 2023
• Last Updated: July 12, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)