- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02909764
Shifting Salty Taste Preferences in Children
6. september 2019 oppdatert av: 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.
Studieoversikt
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
39
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19104
- Monell Chemical Senses Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
7 år til 65 år (Barn, Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Healthy
- Willingness to consume no other cereals during intervention
Exclusion Criteria:
- Allergies and/or taking medication that affects taste
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Ingen inngripen: Control Group
Children will receive regularly salted cereal to consume 4 times per week over a 2-month period.
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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Most Preferred Level of Salt Taste
Tidsramme: Baseline (time 0) and after 8-week intervention
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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 |
Tiltaksbeskrivelse |
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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Samarbeidspartnere og etterforskere
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Sponsor
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. januar 2016
Primær fullføring (Faktiske)
1. august 2016
Studiet fullført (Faktiske)
1. desember 2016
Datoer for studieregistrering
Først innsendt
1. september 2016
Først innsendt som oppfylte QC-kriteriene
19. september 2016
Først lagt ut (Anslag)
21. september 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
30. september 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. september 2019
Sist bekreftet
1. september 2019
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 823281
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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