Evaluation of Sodium Excretion and Dietary Intake Via a New Sodium Food Frequency Questionnaire

NCT07717645 — Not applicable, Completed, 100 participants, Toros University

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EVALUATION OF URINARY SODIUM EXCRETION AND DETERMINATION OF DIETARY SODIUM INTAKE BY THE DEVELOPMENT OF A SODIUM ADDED FOOD FREQUENCY QUESTIONNAIRE

Registry	NCT07717645
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, single group, masking: none, basic science
Enrollment	100 (Actual)
Sponsor	Toros University (Other)
Conditions	Healthy Adult, Alcohol Abstinence, Tobacco Abstinence
Interventions	Dietary Assessment (BTS-Salt), Urinary Analysis (Gold Standard vs. Practical), Nutritional Monitoring, Anthropometric & Lifestyle Assessment (Other)
Dates	start 2022-01-01, primary completion 2022-06-01, completion 2022-09-01, first posted 2026-07-21, last updated 2026-07-22
Locations	1 site in Turkey (Türkiye)

-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 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.

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+Arms and interventions

Arm	Type	Interventions	Description
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 Assessment	A sample group used to test the practical applicability of the BTS-Salt questionnaire in a real-world counseling setting.

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 Monitoring (Other): 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 Assessment (Other): 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).

+Outcome measures

Primary outcomes

Validation of the 'BTS-Salt' Questionnaire and Spot Urine Analysis for Estimating Dietary Sodium Intake in Healthy Adults [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 [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.

+Eligibility

Sex: All, ages: 19 Years to 64 Years, accepts healthy volunteers

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

+Locations (1)

Facility	City	Country	Status
Toros University	Mersin, Mersin	Turkey (Türkiye)

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