- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07726394
Effects of a Six-Day Whole-Diet Intervention on Taste Perception and Dietary Behaviour in Young Adults
Effects of a Six-Day Whole-Diet Intervention on Taste Perception, Dietary Behaviour, and Individual Differences in Young Adults
Обзор исследования
Статус
Условия
Подробное описание
Excess dietary sodium intake is a major modifiable risk factor for hypertension and cardiovascular disease. Public health strategies often assume that reducing exposure to salty foods will lower salt preference and encourage healthier food choices through sensory adaptation; however, evidence from whole-diet interventions conducted under real-world conditions remains limited and inconsistent. Dietary sodium consumption substantially exceeds recommended levels in many countries, including Malaysia, and contributes to the global burden of hypertension and cardiovascular disease. Public health sodium reduction programmes are based on the premise that lowering exposure to salty foods can gradually shift taste preferences towards less salty diets through sensory adaptation. However, evidence supporting this mechanism is mixed, and most previous studies have relied on controlled laboratory settings, single foods, or salt solutions rather than whole-diet interventions.
The study aims to determine whether short-term changes in dietary sodium exposure are sufficient to modify salt taste perception and related eating behaviors and to identify factors associated with individual variation in these responses. The primary objective is to determine whether increasing or decreasing exposure to salty foods over six days alters salt-related taste perception compared with maintaining usual dietary habits. Secondary objectives are to examine changes in sodium intake and appetite-related outcomes and to explore demographic and anthropometric factors associated with taste perception responses. The findings will improve understanding of short-term sensory adaptation to dietary sodium exposure and provide evidence relevant to sodium reduction policies, food reformulation efforts, and behavioral interventions aimed at reducing population sodium intake.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
Selangor
-
Subang Jaya, Selangor, Малайзия, 47500
- Department of Biomedical Sciences, Sir Jeffrey Cheah Sunway Medical School, Faculty of Medical and Life Sciences, Sunway University,.
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Being a student or staff member of Sunway University or Sunway College
- Aged 18-35 years
- Able to communicate in English
- Regularly consuming breakfast
- Being willing and able to comply with all study procedures.
Exclusion Criteria:
- Vegan/smokers/with chronic medical conditions (e.g., hypertension or diabetes)
- Food allergies
- Pregnant or breastfeeding
- Currently dieting or attempting to lose weight
- History of smell or taste impairment
- Use medications or supplements that could affect taste perception.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Increase salty food consumption
Participants increase intake of salty foods and beverages.
|
Participants assigned to the increase group were instructed to increase their consumption of salty-tasting foods and beverages for six consecutive days (Days 1-6) while living in their usual environment.
Participants selected their own foods and beverages but were encouraged to choose options consistent with a higher-salt dietary pattern.
Written guidance and meal examples were provided to support implementation.
Outcomes were assessed at baseline (Day 1) and after the intervention (Day 7).
|
|
Экспериментальный: Decrease salty food consumption
Participants decrease intake of salty foods and beverages.
|
Participants assigned to the decrease group were instructed to reduce their consumption of salty-tasting foods and beverages for six consecutive days (Days 1-6). Participants selected their own foods and beverages while attempting to minimize intake of high-salt items according to written guidance and examples. Outcomes were assessed at baseline (Day 1) and after the intervention (Day 7). A six-day, self-directed dietary intervention designed to reduce exposure to salty foods and beverages under free-living conditions. Participants modified their habitual diet without direct provision of foods by the investigators |
|
Активный компаратор: Maintain usual diet
Participants continue their habitual dietary practices
|
Participants assigned to the maintain group were instructed to continue their usual eating habits and dietary practices for six consecutive days without making deliberate changes to salty food consumption. Outcomes were assessed at baseline (Day 1) and after the intervention (Day 7). A six-day control condition in which participants maintained their habitual dietary intake under free-living conditions. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Pleasantness
Временное ограничение: Pleasantness ratings will be collected at baseline (Day 1) and Day 7
|
Pleasantness ratings, indicated after tasting three salty foods (Foods 1-3) and three non-salty foods (Foods 4-6), will be measured on a 10-point Likert scale. The rating scores will be averaged across the six test foods to generate composite scores. The aggregated pleasantness score will be used to capture overall taste responses rather than food-specific effects, consistent with whole-diet taste exposure theory. |
Pleasantness ratings will be collected at baseline (Day 1) and Day 7
|
|
Desire to eat
Временное ограничение: Desire to eat ratings will be collected at baseline (Day 1) and Day 7
|
Desire to eat ratings, indicated after tasting three salty foods (Foods 1-3) and three non-salty foods (Foods 4-6), will be measured on a 10-point Likert scale. The rating scores will be averaged across the six test foods to generate composite scores. The aggregated pleasantness score will be used to capture overall taste responses rather than food-specific effects, consistent with whole-diet taste exposure theory. |
Desire to eat ratings will be collected at baseline (Day 1) and Day 7
|
|
Saltiness intensity
Временное ограничение: Saltiness intensity ratings will be collected at baseline (Day 1) and Day 7
|
Saltiness intensity ratings, indicated after tasting three salty foods (Foods 1-3) and three non-salty foods (Foods 4-6), will be measured on a 10-point Likert scale. The rating scores will be averaged across the six test foods to generate composite scores. The aggregated pleasantness score will be used to capture overall taste responses rather than food-specific effects, consistent with whole-diet taste exposure theory. |
Saltiness intensity ratings will be collected at baseline (Day 1) and Day 7
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Dietary sodium intake
Временное ограничение: Dietary sodium intake is estimated at baseline (Day 1) and Day 7
|
Dietary sodium intake will be estimated from pre- and post-foods consumed by each participant.
|
Dietary sodium intake is estimated at baseline (Day 1) and Day 7
|
|
Sodium Density
Временное ограничение: Sodium density will be assessed at baseline (Day 1) and Day 7
|
Sodium density (mg/g) will be computed to distinguish compositional from volumetric changes in sodium intake.
|
Sodium density will be assessed at baseline (Day 1) and Day 7
|
|
Appetite
Временное ограничение: Appetite will be assessed at the baseline (Day 1) and Day 7
|
Appetite will be rated on 0-10 Likert scales at the start of each test session.
|
Appetite will be assessed at the baseline (Day 1) and Day 7
|
|
Adherence
Временное ограничение: Adherence was assessed only on Day 7
|
Adherence is a self-reported measure rated on a 10-point Likert scale.
|
Adherence was assessed only on Day 7
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Yee-How Say, PhD, Department of Biomedical Sciences, Sir Jeffrey Cheah Sunway Medical School, Faculty of Medical and Life Sciences, Sunway University, 5, Jalan Universiti, Bandar Sunway, 47500 Subang Jaya, Selangor, Malaysia.
Публикации и полезные ссылки
Общие публикации
- Mojadadi A, Au A, Ortiz Cerda T, Shao JY, O'Neil T, Bell-Anderson K, Andersen JW, Webb J, Salah W, Ahmad G, Harris HH, Witting PK. Dietary supplementation of male mice with inorganic, organic or nanoparticle selenium preparations: evidence supporting a putative gut-thyroid-male fertility axis. Redox Rep. 2025 Dec;30(1):2495367. doi: 10.1080/13510002.2025.2495367. Epub 2025 Apr 25.
- Bielat AD, Rogers PJ, Appleton KM. Effects of a six-day, whole-diet sweet taste intervention on pleasantness, desire for and intakes of sweet foods: a randomised controlled trial. Br J Nutr. 2025 Jan 28;133(2):277-288. doi: 10.1017/S0007114524003209. Epub 2024 Dec 19.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- SunwayU
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .