NocturiaNCT04526340
Food and Salt Handling in Diuresis
A study testing Blood sample, Bio-impedance measurement (BIA) and Ingestion of testing nutrient/food capsules in people with Nocturia and Polyuria, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- What is being tested?
- Blood sample, Bio-impedance measurement (BIA) and Ingestion of testing nutrient/food capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteBelgium
- Study dates
- 24 Jun 2019to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Volunteers with an implanted electronic device (e.g. Pacemaker)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Food and Salt Handling in Diuresis: Research on Effects and Mechanisms of Food and Nutrients in Urine Output and Composition
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.
Read the detailed description
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.
- Being tested
- Blood sample, Bio-impedance measurement (BIA), Ingestion of testing nutrient/food capsules, Urine sample
- Medical subject headings
- Nocturia, Polyuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleDiagnostic test
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).
Bio-impedance measurement (BIA)Diagnostic test
for every 30 minutes for 4 hours
Ingestion of testing nutrient/food capsulesDietary supplement
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.
Urine sampleDiagnostic test
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)
| Study group | Role | What they receive |
|---|---|---|
| Nutrient day | Experimental | on the nutrient day the subjects will take the testing food/nutrient capsules with 500 ml water Receives: Diagnostic Test: Blood sample; Diagnostic Test: Bio-impedance measurement (BIA); Dietary Supplement: Ingestion of testing nutrient/food capsules; Diagnostic Test: Urine sample |
| Control day | Placebo comparator | on the control day the subjects will take 500 ml water without nutrient/food capsules Receives: Diagnostic Test: Blood sample; Diagnostic Test: Bio-impedance measurement (BIA); Diagnostic Test: Urine sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 4 hours
Secondary outcomes (1)
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
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start24 Jun 2019
- Primary completion31 Dec 2020
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NocturiaStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karel Everaert, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04526340
- Sponsor's protocol ID
- EC 2019/0710
- Status last verified
- Sep 2024
- First submitted
- 12 Aug 2020
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food and Salt Handling in Diuresis: Research on Effects and Mechanisms of Food and Nutrients in Urine Output and Composition
- ClinicalTrials.gov ID
- NCT04526340
- Acronym / sponsor ID
- EC 2019/0710
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 25 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutrient day | Experimental | Diagnostic Test: Blood sample, Diagnostic Test: Bio-impedance measurement (BIA), Dietary Supplement: Ingestion of testing nutrient/food capsules, Diagnostic Test: Urine sampleon the nutrient day the subjects will take the testing food/nutrient capsules with 500 ml water |
| Control day | Placebo comparator | Diagnostic Test: Blood sample, Diagnostic Test: Bio-impedance measurement (BIA), Diagnostic Test: Urine sampleon the control day the subjects will take 500 ml water without nutrient/food capsules |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Volunteers with an implanted electronic device (e.g. Pacemaker)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample2 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). | Diagnostic test | Control day, Nutrient day |
| Bio-impedance measurement (BIA)for every 30 minutes for 4 hours | Diagnostic test | Control day, Nutrient day |
| Ingestion of testing nutrient/food capsulesThe 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. | Dietary supplement | Nutrient day |
| Urine sample3 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) | Diagnostic test | Control day, Nutrient day |
Primary outcome
Change in urine volume (production) after ingestion of nutrient/food capsules
Time frame: 4 hours
the aim of this outcome is to check the effect on urine production after taking the capsules
Change in urine composition after ingestion of nutrient/food capsules
Time frame: 4 hours
the aim of this outcome is to check the effect on urine composition after taking the capsules
Change in serum composition after ingestion of nutrient/food capsules
Time frame: 4 hours
this aims to evaluate the effect in serum composition after taking the pills
1 secondary outcome
Change in body water distribution after ingestion of nutrients/food capsules
Time frame: 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karel Everaert, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample, Bio-impedance measurement (BIA) and Ingestion of testing nutrient/food capsules in people with Nocturia and Polyuria, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in urine volume (production) after ingestion of nutrient/food capsules (time frame: 4 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.