Healthy AdultNCT07717645
Evaluation of Sodium Excretion and Dietary Intake Via a New Sodium Food Frequency Questionnaire
A study testing Dietary Assessment (BTS-Salt), Urinary Analysis (Gold Standard vs. Practical) and Nutritional Monitoring in people with Healthy Adult and Alcohol Abstinence, run by Toros University at 1 site in Turkey (Türkiye).
Trial summary
DETERMINATION OF URINARY SODIUM EXCRETION AND DIETARY SODIUM INTAKE IN ADULTS BY DEVELOPING A FOOD FREQUENCY QUESTIONNAIRE FOR ADDED-SALT FOODS Dear Participant, A doctoral thesis study titled "Determination of Urinary Sodium Excretion and Dietary Sodium Intake in Adults by Developing a Food Frequency Questionnaire… Read more about this study
- Who is it for?
- Ages 19 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult, Alcohol Abstinence, Tobacco Abstinence
- What is being tested?
- Dietary Assessment (BTS-Salt), Urinary Analysis (Gold Standard vs. Practical) and Nutritional Monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 1 Sep 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 19 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Absence of any physician-diagnosed chronic conditions.
- Not being on any pharmacological treatment.
- Maintaining regular follow-ups at the designated Nutrition and Diet Counseling Centers.
- Providing written informed consent for study participation.
- Age range of 19-64 years.
Who cannot join
- Presence of chronic medical conditions.
- Inability to maintain regular follow-ups at the designated nutrition and diet counseling centers during the 3-month study period.
- Being outside the 19-64 age range.
- Current use of prescription drugs and/or nutritional supplements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EVALUATION OF URINARY SODIUM EXCRETION AND DETERMINATION OF DIETARY SODIUM INTAKE BY THE DEVELOPMENT OF A SODIUM ADDED FOOD FREQUENCY QUESTIONNAIRE
DETERMINATION OF URINARY SODIUM EXCRETION AND DIETARY SODIUM INTAKE IN ADULTS BY DEVELOPING A FOOD FREQUENCY QUESTIONNAIRE FOR ADDED-SALT FOODS Dear Participant, A doctoral thesis study titled "Determination of Urinary Sodium Excretion and Dietary Sodium Intake in Adults by Developing a Food Frequency Questionnaire for Added-Salt Foods" is being conducted by Ayşe Gökçe Alp, a PhD student in the Department of Nutrition and Dietetics at Hasan Kalyoncu University. The valuable contributions of participants are expected, and participation in the study is requested. No fee will be requested from participants for participation in this study, and no payment will be made to participants. The investigators thank participants in advance for their cooperation.
The questionnaire has been designed to determine participants' general information (such as age, occupation, and marital status), nutritional habits (such as number of meals and meal-skipping status), food consumption status, food preferences, and lifestyle (such as physical activity level). In addition, height, body weight, and various circumference measurements (waist, hip, neck) will be taken by the researcher.
Read more
Within the scope of the study, 24-hour and spot (one-time) urine samples will be collected. For the 24-hour urine collection process, after the first morning urine is discarded, all urine produced during the day - starting with the second urination and including the first urination of the following day - will be collected. The 24-hour urine collection will take place on the second day of the food consumption record period; after the first urine is discarded, all urine collected throughout the day will be delivered to the researcher on the third day. Urine samples must be stored in a dark, cool environment at home. The spot urine sample will be collected on the third day, at the same time as the food consumption records and anthropometric measurements are taken.
The responses provided by participants will be kept strictly confidential, will be used solely for scientific purposes, and will not be used outside the scope of this research.
- Conditions
- Healthy Adult, Alcohol Abstinence, Tobacco Abstinence
- Being tested
- Dietary Assessment (BTS-Salt), Urinary Analysis (Gold Standard vs. Practical), Nutritional Monitoring, Anthropometric & Lifestyle Assessment
- Keywords
- salt consumption, sodium intake, food consumption frequency, urinary sodium excretion, urinary creatinine excretion
- Medical subject headings
- Alcohol Abstinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Assessment (BTS-Salt)Other
Description: Application of the newly developed "Food Frequency Questionnaire for Added-Salt Foods" (BTS-Salt).
Purpose: To estimate daily sodium and table salt intake through self-reported consumption frequency of specific high-salt foods.
Urinary Analysis (Gold Standard vs. Practical)Other
24-Hour Urine Collection: Participants collect all urine over a 24-hour period to measure absolute sodium and creatinine excretion.
Spot Urine Collection: A single urine sample collected on the 3rd day to test its validity as a simpler substitute for the 24-hour collection.
Nutritional MonitoringOther
3-Day Dietary Record: Participants keep a detailed log of all food and drink consumed for three consecutive days to provide a baseline for comparison with the BTS-Salt results.
Anthropometric & Lifestyle AssessmentOther
Physical Measurements: Measurement of body weight, height, and circumferences (waist, hip, neck).
Lifestyle Survey: Data collection on physical activity levels and general eating habits (e.g., meal skipping).
| Study group | Role | What they receive |
|---|---|---|
| Validation Arm (Stage 1) | Other | A group of 40 healthy adults (aged 19-64) used to test the reliability of the new assessment tools against the gold standard (24-hour urine). Receives: Other: Dietary Assessment (BTS-Salt); Other: Urinary Analysis (Gold Standard vs. Practical) |
| Application Arm (Stage 2) | Other | A sample group used to test the practical applicability of the BTS-Salt questionnaire in a real-world counseling setting. Receives: Other: Dietary Assessment (BTS-Salt); Other: Nutritional Monitoring; Other: Anthropometric & Lifestyle Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of the 'BTS-Salt' Questionnaire and Spot Urine Analysis for Estimating Dietary Sodium Intake in Healthy Adults
The research tests the substitutability of spot urine for 24-hour urine collection and the validity of the BTS-Salt questionnaire in reflecting true sodium intake. Therefore, the significance of the relationship and the degree of agreement between the 24-hour urinary sodium excretion-the gold standard-and alternative methods form the focal point of all statistical analyses.
Measured: 24 months
The research tests the substitutability of spot urine for 24-hour urine collection and the validity of the BTS-Salt questionnaire in reflecting true sodium intake. Therefore, the significance of the relationship and the degree of agreement between the 24
The research tests the substitutability of spot urine for 24-hour urine collection and the validity of the BTS-Salt questionnaire in reflecting true sodium intake. Therefore, the significance of the relationship and the degree of agreement between the 24-hour urinary sodium excretion-the gold standard-and alternative methods form the focal point of all statistical analyses.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start1 Jan 2022
- Primary completion1 Jun 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toros University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Gökçe ALP, Toros University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07717645
- Sponsor's protocol ID
- 2022/001
- Status last verified
- Jul 2026
- First submitted
- 14 May 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF URINARY SODIUM EXCRETION AND DETERMINATION OF DIETARY SODIUM INTAKE BY THE DEVELOPMENT OF A SODIUM ADDED FOOD FREQUENCY QUESTIONNAIRE
- ClinicalTrials.gov ID
- NCT07717645
- Acronym / sponsor ID
- 2022/001
- Conditions
- Healthy Adult, Alcohol Abstinence, Tobacco Abstinence
- Keywords
- salt consumption, sodium intake, food consumption frequency, urinary sodium excretion, urinary creatinine excretion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Toros UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 21 Jul 2026 (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.
DETERMINATION OF URINARY SODIUM EXCRETION AND DIETARY SODIUM INTAKE IN ADULTS BY DEVELOPING A FOOD FREQUENCY QUESTIONNAIRE FOR ADDED-SALT FOODS Dear Participant, A doctoral thesis study titled "Determination of Urinary Sodium Excretion and Dietary Sodium Intake in Adults by Developing a Food Frequency Questionnaire for Added-Salt Foods" is being conducted by Ayşe Gökçe Alp, a PhD student in the Department of Nutrition and Dietetics at Hasan Kalyoncu University. The valuable contributions of participants are expected, and participation in the study is requested. No fee will be requested from participants for participation in this study, and no payment will be made to participants. The investigators thank participants in advance for their cooperation.
The questionnaire has been designed to determine participants' general information (such as age, occupation, and marital status), nutritional habits (such as number of meals and meal-skipping status), food consumption status, food preferences, and lifestyle (such as physical activity level). In addition, height, body weight, and various circumference measurements (waist, hip, neck) will be taken by the researcher.
Within the scope of the study, 24-hour and spot (one-time) urine samples will be collected. For the 24-hour urine collection process, after the first morning urine is discarded, all urine produced during the day - starting with the second urination and including the first urination of the following day - will be collected. The 24-hour urine collection will take place on the second day of the food consumption record period; after the first urine is discarded, all urine collected throughout the day will be delivered to the researcher on the third day. Urine samples must be stored in a dark, cool environment at home. The spot urine sample will be collected on the third day, at the same time as the food consumption records and anthropometric measurements are taken.
The responses provided by participants will be kept strictly confidential, will be used solely for scientific purposes, and will not be used outside the scope of this research.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Validation Arm (Stage 1) | Other | Other: Dietary Assessment (BTS-Salt), Other: Urinary Analysis (Gold Standard vs. Practical)A group of 40 healthy adults (aged 19-64) used to test the reliability of the new assessment tools against the gold standard (24-hour urine). |
| Application Arm (Stage 2) | Other | Other: Dietary Assessment (BTS-Salt), Other: Nutritional Monitoring, Other: Anthropometric & Lifestyle AssessmentA sample group used to test the practical applicability of the BTS-Salt questionnaire in a real-world counseling setting. |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Absence of any physician-diagnosed chronic conditions.
- Not being on any pharmacological treatment.
- Maintaining regular follow-ups at the designated Nutrition and Diet Counseling Centers.
- Providing written informed consent for study participation.
- Age range of 19-64 years.
Key exclusion criteria (4 listed)
- Presence of chronic medical conditions.
- Inability to maintain regular follow-ups at the designated nutrition and diet counseling centers during the 3-month study period.
- Being outside the 19-64 age range.
- Current use of prescription drugs and/or nutritional supplements.
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 |
|---|---|---|
| Dietary Assessment (BTS-Salt)Description: Application of the newly developed "Food Frequency Questionnaire for Added-Salt Foods" (BTS-Salt). Purpose: To estimate daily sodium and table salt intake through self-reported consumption frequency of specific high-salt foods. | Other | Application Arm (Stage 2), Validation Arm (Stage 1) |
| Urinary Analysis (Gold Standard vs. Practical)24-Hour Urine Collection: Participants collect all urine over a 24-hour period to measure absolute sodium and creatinine excretion. Spot Urine Collection: A single urine sample collected on the 3rd day to test its validity as a simpler substitute for the 24-hour collection. | Other | Validation Arm (Stage 1) |
| Nutritional Monitoring3-Day Dietary Record: Participants keep a detailed log of all food and drink consumed for three consecutive days to provide a baseline for comparison with the BTS-Salt results. | Other | Application Arm (Stage 2) |
| Anthropometric & Lifestyle AssessmentPhysical Measurements: Measurement of body weight, height, and circumferences (waist, hip, neck). Lifestyle Survey: Data collection on physical activity levels and general eating habits (e.g., meal skipping). | Other | Application Arm (Stage 2) |
Primary outcome
Validation of the 'BTS-Salt' Questionnaire and Spot Urine Analysis for Estimating Dietary Sodium Intake in Healthy Adults
Time frame: 24 months
The research tests the substitutability of spot urine for 24-hour urine collection and the validity of the BTS-Salt questionnaire in reflecting true sodium intake. Therefore, the significance of the relationship and the degree of agreement between the 24-hour urinary sodium excretion-the gold standard-and alternative methods form the focal point of all statistical analyses.
The research tests the substitutability of spot urine for 24-hour urine collection and the validity of the BTS-Salt questionnaire in reflecting true sodium intake. Therefore, the significance of the relationship and the degree of agreement between the 24
Time frame: 24 months
The research tests the substitutability of spot urine for 24-hour urine collection and the validity of the BTS-Salt questionnaire in reflecting true sodium intake. Therefore, the significance of the relationship and the degree of agreement between the 24-hour urinary sodium excretion-the gold standard-and alternative methods form the focal point of all statistical analyses.
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 22 Jul 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Assessment (BTS-Salt), Urinary Analysis (Gold Standard vs. Practical) and Nutritional Monitoring in people with Healthy Adult and Alcohol Abstinence, run by Toros University at 1 site in Turkey (Türkiye).
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 5 inclusion and 4 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 22 Jul 2026. 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 Turkey (Türkiye). 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. 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?
Validation of the 'BTS-Salt' Questionnaire and Spot Urine Analysis for Estimating Dietary Sodium Intake in Healthy Adults (time frame: 24 months). The study lists 2 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 22 Jul 2026.