Effect of Body Weight Loading on Urinary Electrolyte Excretion

NCT03213717 | Completed

• 1 other identifier: EBU
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Title: Effect of body weight loading on urinary electrolyte excretion Swedish Title: Effekt av belastning på utsöndring av elektrolyter Study period: Q2-Q3 2017 Study site: The study will be performed at the Institution for Neurology and Physiology, Sahlgrenska Academy, University of Gothenburg. Principal Investigator is John-Olov Jansson, MD, PhD, Professor at Institute of Neuroscience and Physiology, University of Gothenburg Background and study design: Weight reduction can be obtained by decreased appetite or increased metabolism. However, acute weight loss can also be obtained by loss of fluids - for example by increased urinary loss of fluid and salts, so called elctrolytes. Preliminary results from a laboratory lesson for the Master of Science in Medicine program at University of Gothenburg suggest that carrying a 10 kg weight vest could increase urinary excretion of Na+, K+ and Cl-. The purpose of this study is to investigate this further in a more controlled research setting. If confirmed, the results could potentially contribute to the development of potent diuretics or obesity medicines. The study will include 15 healthy volunteers and consist of three study days with about one week between each study day. The study subjects will go through a different study procedure each study day, and a randomized cross-over study design will be used to determine which procedure each day. Procedure 1: Wearing a weight vest with 10 % of body weight standing for seven hours. The study subject is allowed to sit for 10 minutes each hour. The reason for this is that it has been considered that the effect may be transmitted by weight loading of the lower extremities. Procedure 2: Wearing a weight vest with 1 % of body weight standing for seven hours, as a control for procedure 1, with lower loading. The study subject is allowed to sit for 10 minutes each hour. Procedure 3: Wearing a weight vest with 1 % of body weight sitting for seven hours. This is a procedure with even less loading of the lower extremities than during procedure 2. Urine- and blood samples, as well as heart rate and blood pressure measurements, will be collected during the study days and analyzed in order to address the primary and secondary objectives of the study.

Conditions

Obesity; Edema

Keywords

Obesity; Loading; Edema; Urine

Outcome Measures

Primary Outcomes (1)

• Sodium concentration

  In urine

  7 hours from start

Secondary Outcomes (17)

• Urine Volume

  7 hours from start

• Potassium concentration

  7 hours from start

• Chloride concentration

  7 hours from start

• Calcium concentration

  7 hours from start

• Creatinine

  7 hours from start

Study Arms (3)

Procedure 1

EXPERIMENTAL

Wearing a weight vest with 10 % of body weight standing for seven hours. The study subject is allowed to sit for 10 minutes each hour. The reason for this is because it has been considered that the effect may be transmitted by weight loading of the lower extremities.

Other: Heavy Casall HIT weight vest; Behavioral: Standing; Dietary Supplement: Water load

Procedure 2

ACTIVE COMPARATOR

Wearing a weight vest with 1 % of body weight standing for seven hours. The study subject is allowed to sit for 10 minutes each hour.

Behavioral: Standing; Dietary Supplement: Water load; Other: Light Casall HIT weight vest

Procedure 3

ACTIVE COMPARATOR

Wearing a weight vest with 1 % of body weight sitting for seven hours. This is a control group without loading of the lower extremities. This is also the normal working position for many sedentary jobs (e.g. office workers) and why this is of special interest for further investigation. There is a large body of investigative literature showing the negative health consequences of the sitting working position.

Dietary Supplement: Water load; Behavioral: Sitting; Other: Light Casall HIT weight vest

Interventions

Heavy Casall HIT weight vest OTHER

A weight west with a weight of 10 % compared to the study subject

Procedure 1

Standing BEHAVIORAL

Study subjects will be standing for at least 50 minutes every hour

Procedure 1; Procedure 2

Water load DIETARY_SUPPLEMENT

Study subjects will drink 5 ml per kg body weight at the start of experiment and continue drinking the same volume as excreted by the kidneys during the experiment

Procedure 1; Procedure 2; Procedure 3

Sitting BEHAVIORAL

Study subjects will be sitting for at least 50 minutes of every hour

Procedure 3

Light Casall HIT weight vest OTHER

A weight west with a weight of 1 % compared to the study subject

Procedure 2; Procedure 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers
• Signed informed consent
• Willingness to comply with study restrictions of not using alcohol, coffee etc during the hours specified below prior to each study day

You may not qualify if:

• Subjects must not enter the study if any of the following are present:
• Chronic disease requiring continuous medication or harden the participation in the study as judged by the investigator
• High blood pressure (\>140/90 mm Hg)
• Chronic pain such as pain that is constant and impairs quality of life
• Consumption of medications during the last 7 days prior the study day, not including contraceptives
• 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
• Smoking, snuff use or intake of drugs during the last 7 days prior the study day
• Intake of alcohol during the last 24 hours prior the study day
• Intake of coffee and tea during the last 12 hours prior the study day
• Strenuous physical activity before the study during the last 6 hours prior the study day
• Pregnancy: Females of childbearing potential must confirm to use reliable contraception and not suspect to be pregnant

Sponsors & Collaborators

• Göteborg University: lead
• Sahlgrenska University Hospital: collaborator

Study Sites (1)

University of Gothenburg

Gothenburg, Box 100, S-405 30, Sweden

Location

MeSH Terms

Conditions

Obesity; Edema

Interventions

Standing Position; Sitting Position

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• John-Olov Jansson

  Univeristy of Gothenburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: We will recruit healthy individuals who work at or close to the Institution of Neuroscience and Physiology at the Sahlgrenska Academy. We will ask healthy people who do not know the hypothesis of the study. Each study subject will be given a randomized code to use for the study. Only the study subject and the investigator will be able to connect each study subject with their randomized code. This will only be used under special circumstances, for example, if a study subject requests removal of his or her study data. As this study uses a cross-over design each subject will then be its own matched control. Subject eligibility will be established before enrolment and randomization. Subjects will be randomized strictly sequentially, as subjects are eligible for randomization. If a subject discontinues from the study, the subject number will not be reused, and the subject will not be allowed to re-enter the study.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is executed with all 15 study subjects over three study days with one week between each study day. In order to decrease the variation of the measurement values and increase the power of the study we will use a cross-over study design. The study subjects will on one of the days wear a weight vest with 10 % of body weight in the standing position, on one of the days the same study subject will wear a weight vest with 1 % of body weight in the standing position and on one of the days the same study subject will wear a weight vest with 1 % of body weight in the sitting position. Hence, three procedures are included in the study. Each of the procedure corresponds to a separate day.

Study Record Dates

• First Submitted: July 4, 2017
• First Posted: July 11, 2017
• Study Start: June 13, 2017
• Primary Completion: July 4, 2017
• Study Completion: July 4, 2017
• Last Updated: April 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)