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

20. juli 2026 oppdatert av: Ayşe Gökçe ALP, Toros University

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.

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.

Studieoversikt

Studietype

Intervensjonell

Registrering (Faktiske)

100

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Ja

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: Randomisert
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: Validation Arm (Stage 1)
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).

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.

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.

Annen: Application Arm (Stage 2)
A sample group used to test the practical applicability of the BTS-Salt questionnaire in a real-world counseling setting.

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.

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.

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).

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Validation of the 'BTS-Salt' Questionnaire and Spot Urine Analysis for Estimating Dietary Sodium Intake in Healthy Adults
Tidsramme: 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.
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
Tidsramme: 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.
24 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. januar 2022

Primær fullføring (Faktiske)

1. juni 2022

Studiet fullført (Faktiske)

1. september 2022

Datoer for studieregistrering

Først innsendt

14. mai 2026

Først innsendt som oppfylte QC-kriteriene

16. juli 2026

Først lagt ut (Faktiske)

21. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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