- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02909764
Shifting Salty Taste Preferences in Children
6. september 2019 opdateret af: Monell Chemical Senses Center
Salty Taste: Assessing a Strategy to Reduce Children's Preference
The goals of the proposed research are to determine whether repeated exposure to a low sodium food will result in reduced preference for salt in that food among children; and to determine whether such reductions in preference are related to dietary intake of salt, taste receptor genotype, and anthropometric and physiological measures.
Studieoversigt
Detaljeret beskrivelse
This is a within- and between-subjects randomized controlled trial on children consuming either a low sodium or a higher sodium cereal over a 2-month period to determine if repeated exposure to the low sodium cereal is effective for reducing preference for salt in that food.
Children will be genotyped for markers related to taste, dietary intake will be recorded, and anthropometric and physiological measures will be collected at baseline.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
39
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- Monell Chemical Senses Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
7 år til 65 år (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Healthy
- Willingness to consume no other cereals during intervention
Exclusion Criteria:
- Allergies and/or taking medication that affects taste
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Ingen indgriben: Control Group
Children will receive regularly salted cereal to consume 4 times per week over a 2-month period.
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Eksperimentel: Low Sodium Group
Intervention: Children will receive low sodium cereal to consume 4 times per week over a 2-month period.
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Breakfast Cereal
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Most Preferred Level of Salt Taste
Tidsramme: Baseline (time 0) and after 8-week intervention
|
Children were presented with pairs of broths with varying concentrations of added salt (0.16, 0.24, 0.38, 0.61, 1.05 M) (17) .
The first pair of broths (0.24 and 0.61 M salt) presented were from the middle range of concentrations.
Children were instructed to taste each sample within a pair for 5 seconds, to rinse between tastings, and then to point to the sample they liked better.
Each subsequent pair of samples contained the concentration selected by the participant paired with an adjacent stimulus concentration.
This pattern continued until the child either chose the same concentration when paired with both a lower and higher concentration in two consecutive pairs or chose either the highest or the lowest concentration twice consecutively.
The entire task was repeated a, with stimulus pairs presented in reverse order.
The geometric mean of the two concentrations chosen in the first and second series was calculated to determine most preferred levels of salt.
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Baseline (time 0) and after 8-week intervention
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Relative Preference for Regular vs Low Sodium Cereal
Tidsramme: At baseline and after 8-week intervention
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The number of children who preferred the taste of the low salt cereal when compared to the regular sodium cereal
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At baseline and after 8-week intervention
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Salt Taste Detection Thresholds
Tidsramme: Baseline and after 8-week intervention
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Detection thresholds (the lowest level of salt detect by taste) were measured via a two-alternative forced-choice procedure
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Baseline and after 8-week intervention
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Most Preferred Level of Sucrose
Tidsramme: At baseline and after 8-week intervention
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Children were presented with pairs of sucrose solutions of varying concentrations (0.09, 0.18, 0.35, 0.70, 1.05 M).
The first pair presented were from the middle range of concentrations.
Children tasted each sample and then pointed to the sample they liked better.
Each subsequent pair of samples presented contained the concentration selected by the child paired with an adjacent stimulus concentration.
This pattern continued until the child either chose the same concentration when paired with both a lower and higher concentration in two consecutive pairs or chose either the highest or the lowest concentration twice consecutively.
The entire task was repeated after a 3-minute break, with stimulus pairs presented in reverse order.
The geometric mean of the two concentrations chosen in the first and second series was calculated to determine the most preferred levels of sucrose.
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At baseline and after 8-week intervention
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Intake of Cereal During Intervention Period
Tidsramme: 28 days
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Mothers recorded the amount of cereal their children ingested during 28 days of the 8-week, at-home intervention period.
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28 days
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Blood Pressure
Tidsramme: Baseline
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Blood pressure (mmHg) was measured by using an automatic blood pressure machine with pediatric cuff.
Blood pressure will be measured at baseline (time 0).
There were no a priori hypothesis but were collected as baseline characteristic to ensure no differences between the groups.
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Baseline
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. januar 2016
Primær færdiggørelse (Faktiske)
1. august 2016
Studieafslutning (Faktiske)
1. december 2016
Datoer for studieregistrering
Først indsendt
1. september 2016
Først indsendt, der opfyldte QC-kriterier
19. september 2016
Først opslået (Skøn)
21. september 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
30. september 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. september 2019
Sidst verificeret
1. september 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 823281
Plan for individuelle deltagerdata (IPD)
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