- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus 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
Tutkimuksen yleiskatsaus
Tila
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
Selangor
-
Subang Jaya, Selangor, Malesia, 47500
- Department of Biomedical Sciences, Sir Jeffrey Cheah Sunway Medical School, Faculty of Medical and Life Sciences, Sunway University,.
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kaksinkertainen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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).
|
|
Kokeellinen: 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 |
|
Active Comparator: 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. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Pleasantness
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Dietary sodium intake
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: 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.
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- 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.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- SunwayU
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .