An interventional study of Blood sample and Bio-impedance measurement (BIA) in Nocturia and Polyuria, sponsored by University Hospital, Ghent. Completed at 1 site in Belgium. Open to participants aged 20 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by University Hospital, Ghent · Not applicable, Interventional, and Prevention
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.
Research design: Prospective intervention study to investigate the impact of food/nutrients on urine production and fluid distribution in the body.
Study sample: The sample size was calculated for a power of 80% and for control vs. treatment using a paired-sample t-test at the 5% significance level. Thus 30 young healthy volunteers for each food group (total 300 subjects for 10 food/nutrients groups as; leek, asparagus, onion, garlic, cranberry, barley, parsley, cardamom, coffee and salt) with no acute or chronic disease, no use of medication (except contraception), not being pregnant or menstruating at the time of the study, no any food allergies and age between 20-35 years with BMI 18.5-25 kg/m2 will be included. Volunteers with an implanted electronic device (e.g. Pacemaker) will not be included.
Methodology: The subjects will be tested in fasted and sober state in the morning. No food/drink 6hrs prior to the test. The subjects will be asked to take 2 different dosages of testing nutrient and along with 500ml of water and only 500ml water for the control, on 3 different test days. Nutrients will prepared in 1g capsules. The test will last for 4 hrs after taking of the capsules.
Analyses: 3-Days food diary: Once only. For salt, caffeine and energy intake Anthropometric measurements: at the beginning of each test day 2 Blood samples at the beginning and end of the test: Haptoglobin phenotyping (serum), Haptoglobin concentration (μmol/l) (serum), Sodium (mmol/l) (serum), Osmolality (mOsm/kg) (serum), Urea (g/l) (serum), Creatinine (g/dl) (serum) 3 Urine samples at the beginning, after 2 hrs and at the end of the test: Total voided volume, Osmolality (mOsm/kg), Creatinine (g/dl), Sodium (mmol/l), Potassium (mmol/l), Urea (g/l) Bio-impedance measurement (BIA): for every 30 min for 4 hours
Sample analysis and storage: Half of the urine samples and blood samples are sent immediately after collection to the university hospital Gent clinical laboratory. The other half of the samples will be stored for a certain time in a freezer at -80 °C and will be processed and examined for a second time. The other urine samples and blood samples that are not used for the research are stored as a bio-bank.
134 studies on the registry are indexed under Nocturia; 22 are open to participants now.
This study's enrollment of 21 is below the median of 71 across 108 interventional studies indexed under Nocturia.
Browse Nocturia studies →University Hospital, Ghent is the lead sponsor of 689 studies on the registry; 160 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
on the nutrient day the subjects will take the testing food/nutrient capsules with 500 ml water
Diagnostic Test: Blood sample · Diagnostic Test: Bio-impedance measurement (BIA) · Dietary Supplement: Ingestion of testing nutrient/food capsules · Diagnostic Test: Urine sample
on the control day the subjects will take 500 ml water without nutrient/food capsules
Diagnostic Test: Blood sample · Diagnostic Test: Bio-impedance measurement (BIA) · Diagnostic Test: Urine sample
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)
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
Time frame: 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
Time frame: 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
Time frame: 4 hours
Change in body water distribution after ingestion of nutrients/food capsules
using the bio-impedance measurement, the water distribution of the body over 4 hours is tested
Time frame: 4 hours
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2019 to primary completion in Dec 2020, 18 months.
Of 34 interventional studies with no phase under Nocturia, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's 18 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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