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

NCT07717645 | Completed DMC

• 1 other identifier: 2022/001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Adult; Alcohol Abstinence; Tobacco Abstinence

Keywords

salt consumption; sodium intake; food consumption frequency; urinary sodium excretion; urinary creatinine excretion

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  24 months

Study Arms (2)

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).

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.

Other: Dietary Assessment (BTS-Salt); Other: Nutritional Monitoring; Other: Anthropometric & Lifestyle Assessment

Interventions

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).

Application Arm (Stage 2)

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.

Application Arm (Stage 2); Validation Arm (Stage 1)

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.

Validation Arm (Stage 1)

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.

Application Arm (Stage 2)

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Toros University: lead

Study Sites (1)

Toros University

Mersin, Mersin, 33140, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Alcohol Abstinence

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: July 21, 2026
• Study Start: January 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: September 1, 2022
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)