- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07717645
Evaluation of Sodium Excretion and Dietary Intake Via a New Sodium Food Frequency Questionnaire
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.
연구 개요
상태
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Mersin
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Mersin, Mersin, 터키 (Türkiye), 33140
- Toros University
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: 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).
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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. |
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다른: Application Arm (Stage 2)
A sample group used to test the practical applicability of the BTS-Salt questionnaire in a real-world counseling setting.
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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). |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Validation of the 'BTS-Salt' Questionnaire and Spot Urine Analysis for Estimating Dietary Sodium Intake in Healthy Adults
기간: 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
기간: 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
|
공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2022/001
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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