Effect of Body Weight Loading on Urinary Electrolyte Excretion

• Register: ClinicalTrials.gov
• Last refreshed on: 8 January 2018
• Main ID: NCT03213717
• Date of registration: 04/07/2017
• Prospective Registration: No
• Primary sponsor: Göteborg University
• Public title: Effect of Body Weight Loading on Urinary Electrolyte Excretion EBU
• Scientific title: Effect of Body Weight Loading on Urinary Electrolyte Excretion
• Date of first enrolment: June 13, 2017
• Target sample size: 15
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03213717
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Triple (Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Sweden

Contacts

• Name: John-Olov Jansson
• Affiliation: Univeristy of Gothenburg

Key inclusion & exclusion criteria

Inclusion Criteria:

For inclusion in the study, subjects must fulfil the following criteria:

1. Healthy volunteers

2. Signed informed consent

3. Willingness to comply with study restrictions of not using alcohol, coffee etc during
the hours specified below prior to each study day

Exclusion Criteria:

Subjects must not enter the study if any of the following are present:

1. Chronic disease requiring continuous medication or harden the participation in the
study as judged by the investigator

2. High blood pressure (>140/90 mm Hg)

3. Chronic pain such as pain that is constant and impairs quality of life

4. Consumption of medications during the last 7 days prior the study day, not including
contraceptives

5. Consumption of nature medicine or supplements that results in a increased intake of a
specific compound that isn't a nutrient during the last 7 days prior the study day

6. Smoking, snuff use or intake of drugs during the last 7 days prior the study day

7. Intake of alcohol during the last 24 hours prior the study day

8. Intake of coffee and tea during the last 12 hours prior the study day

9. Strenuous physical activity before the study during the last 6 hours prior the study
day

10. Pregnancy: Females of childbearing potential must confirm to use reliable
contraception and not suspect to be pregnant



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Edema

Obesity

Intervention(s)

Other: Heavy Casall HIT weight vest

Other: Light Casall HIT weight vest

Dietary Supplement: Water load

Behavioral: Sitting

Behavioral: Standing

Primary Outcome(s)

Sodium concentration [Time Frame: 7 hours from start]

Secondary Outcome(s)

Glucose [Time Frame: 6.5 hours from start]

Urine Volume [Time Frame: 7 hours from start]

Blood pressure [Time Frame: 7 hours from start]

Osteocalcin [Time Frame: 6.5 hours from start]

Lipocalin2 [Time Frame: 6.5 hours from start]

Potassium [Time Frame: 6.5 hours from start]

Heart Rate [Time Frame: 7 hours from start]

pH [Time Frame: 7 hours from start]

Sclerostin [Time Frame: 6.5 hours from start]

Creatinine [Time Frame: 7 hours from start]

Calcium concentration [Time Frame: 7 hours from start]

Chloride [Time Frame: 6.5 hours from start]

Chloride concentration [Time Frame: 7 hours from start]

Creatinine [Time Frame: 6.5 hours from start]

FGF23 [Time Frame: 6.5 hours from start]

Potassium concentration [Time Frame: 7 hours from start]

Sodium [Time Frame: 6.5 hours from start]

Secondary ID(s)

EBU

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Sahlgrenska University Hospital, Sweden