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Food and Salt Handling in Diuresis

Primary Purpose

Nocturia, Polyuria

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Blood sample
Bio-impedance measurement (BIA)
Ingestion of testing nutrient/food capsules
Urine sample
Sponsored by
University Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nocturia

Eligibility Criteria

20 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Volunteers with an implanted electronic device (e.g. Pacemaker)

Sites / Locations

  • Department of Urology, Ghent University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nutrient day

Control day

Arm Description

on the nutrient day the subjects will take the testing food/nutrient capsules with 500 ml water

on the control day the subjects will take 500 ml water without nutrient/food capsules

Outcomes

Primary Outcome Measures

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
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
Change in serum composition after ingestion of nutrient/food capsules
this aims to evaluate the effect in serum composition after taking the pills

Secondary Outcome Measures

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

Full Information

First Posted
August 12, 2020
Last Updated
December 9, 2022
Sponsor
University Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT04526340
Brief Title
Food and Salt Handling in Diuresis
Official Title
Food and Salt Handling in Diuresis: Research on Effects and Mechanisms of Food and Nutrients in Urine Output and Composition
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
June 24, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
February 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nocturia, Polyuria

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nutrient day
Arm Type
Experimental
Arm Description
on the nutrient day the subjects will take the testing food/nutrient capsules with 500 ml water
Arm Title
Control day
Arm Type
Placebo Comparator
Arm Description
on the control day the subjects will take 500 ml water without nutrient/food capsules
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood sample
Intervention Description
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).
Intervention Type
Diagnostic Test
Intervention Name(s)
Bio-impedance measurement (BIA)
Intervention Description
for every 30 minutes for 4 hours
Intervention Type
Dietary Supplement
Intervention Name(s)
Ingestion of testing nutrient/food capsules
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Urine sample
Intervention Description
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)
Primary Outcome Measure Information:
Title
Change in urine volume (production) after ingestion of nutrient/food capsules
Description
the aim of this outcome is to check the effect on urine production after taking the capsules
Time Frame
4 hours
Title
Change in urine composition after ingestion of nutrient/food capsules
Description
the aim of this outcome is to check the effect on urine composition after taking the capsules
Time Frame
4 hours
Title
Change in serum composition after ingestion of nutrient/food capsules
Description
this aims to evaluate the effect in serum composition after taking the pills
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Change in body water distribution after ingestion of nutrients/food capsules
Description
using the bio-impedance measurement, the water distribution of the body over 4 hours is tested
Time Frame
4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Volunteers with an implanted electronic device (e.g. Pacemaker)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karel Everaert, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Urology, Ghent University Hospital
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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Food and Salt Handling in Diuresis

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