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临床试验/NCT07717645
NCT07717645已完成不适用

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

Toros University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Validation of the 'BTS-Salt' Questionnaire and Spot Urine Analysis for Estimating Dietary Sodium Intake in Healthy Adults

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
19 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Anthropometric & Lifestyle Assessment (Other)

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).

干预措施: Dietary Assessment (BTS-Salt) (Other)

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).

干预措施: Urinary Analysis (Gold Standard vs. Practical) (Other)

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.

干预措施: Dietary Assessment (BTS-Salt) (Other)

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.

干预措施: Nutritional Monitoring (Other)

结局指标

主要结局

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

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayşe Gökçe ALP

PhD

Toros University

研究点 (1)

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