Food and Salt Handling in Diuresis
1 other identifier
interventional
21
1 country
1
Brief Summary
Understanding the impact of food/nutrients on body fluid metabolism is important for improving diagnosis and treatment of nocturia, polyuria in relation to lifestyle interventions. This study on "Food and Salt Handling in Diuresis" examines the role of certain food and nutrients in diuresis. The study design is to investigate the possible acute effects and mechanisms of selected food (which are known to be diuretic) and nutrients (e.g. salt) in diuresis in healthy individuals. The study will provide insights into the management of nocturia, nocturnal polyuria or oedema which are common clinical sign in a wide range of disorders as cardiovascular, renal and metabolic disorders. During the study the volunteers will be asked to ingest a certain dosage of a food/nutrient in capsules along with a defined amount of water (500 ml). 2 Blood and 3 urine samples will be collected at different time points to measure the urine output and urine composition derived by the ingestion of the particular food item. Renal Function Profiling is used as an easy and cheap tool to understand the mechanism of action behind the observed effect in diuresis. Renal function profiles distinguish the osmotic form water diuresis from a change in filtration. Bio-electrical impedance analysis (BIA) is also used to evaluate oedema and fluid volumes in body tissues. BIA is a non-invasive technique based on Ohm's law whereby the resistance of a tissue against an electric current is inversely proportional to the water content and directly proportional to the length of the tissue. For the BIA measurement, a device is used in which 8 tactile electrodes are placed: 2 in contact with the thumb and middle finger of each hand, and 2 in contact with the inside and outside of each foot. Before the start of the measurements, the length and body weight are measured. The resistance of the arms, torso and legs is measured at different frequencies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 24, 2019
CompletedFirst Submitted
Initial submission to the registry
August 12, 2020
CompletedFirst Posted
Study publicly available on registry
August 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2022
CompletedSeptember 19, 2024
September 1, 2024
1.5 years
August 12, 2020
September 5, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
Change in urine volume (production) after ingestion of nutrient/food capsules
the aim of this outcome is to check the effect on urine production after taking the capsules
4 hours
Change in urine composition after ingestion of nutrient/food capsules
the aim of this outcome is to check the effect on urine composition after taking the capsules
4 hours
Change in serum composition after ingestion of nutrient/food capsules
this aims to evaluate the effect in serum composition after taking the pills
4 hours
Secondary Outcomes (1)
Change in body water distribution after ingestion of nutrients/food capsules
4 hours
Study Arms (2)
Nutrient day
EXPERIMENTALon the nutrient day the subjects will take the testing food/nutrient capsules with 500 ml water
Control day
PLACEBO COMPARATORon the control day the subjects will take 500 ml water without nutrient/food capsules
Interventions
2 Blood samples at the beginning and end of the test to analyze; Haptoglobin phenotyping, Haptoglobin concemtration (μmol/l) (serum), Sodium (mmol/l) (serum), Osmolality (mOsm/kg) (serum), Urea (g/l) (serum), Creatinine (g/dl) (serum), Potassium (mmol/l) (serum).
for every 30 minutes for 4 hours
The subjects will be tested in fasted and sober state in the morning. No food/drink 6 hours prior to the test. The subjects will be asked to take 2 different dosages of testing nutrient along with 500ml of water and only water for the control, on 3 different test days. The testing nutrients will be prepared in 1g capsules.
3 Urine samples at the beginning, after 2 hrs and at the end of the test to analyze: Total voided volume, Osmolality (mOsm/kg), Creatinine (g/dl), Sodium (mmol/l), Potassium (mmol/l), Urea (g/l)
Eligibility Criteria
You may qualify if:
- Healthy male/female
- Age between 20-35 years
- No use of medication (except contraception)
- Have no health issues
- Not being pregnant or menstruating at the time of the study
- BMI 18.5 -25 kg / m2
- No food allergies
You may not qualify if:
- Volunteers with an implanted electronic device (e.g. Pacemaker)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Urology, Ghent University Hospital
Ghent, 9000, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karel Everaert, MD, PhD
University Hospital, Ghent
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2020
First Posted
August 25, 2020
Study Start
June 24, 2019
Primary Completion
December 31, 2020
Study Completion
February 28, 2022
Last Updated
September 19, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share