Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04526340 |
| Other study ID # |
EC 2019/0710 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 24, 2019 |
| Est. completion date |
February 28, 2022 |
Study information
| Verified date |
December 2022 |
| Source |
University Hospital, Ghent |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
