- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03442829
Repeated Sweet Breakfasts and Subsequent Sweet Food Preferences and Intakes
1. september 2020 opdateret af: Bournemouth University
Impact of Repeated Sweet Breakfasts on Subsequent Sweet Food Preferences and Intakes
This study will assess the impact of repeated sweet breakfast consumption versus repeated non-sweet breakfast consumption on subsequent sweet and non-sweet food preferences and intakes
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Participants will be randomized to receive either sweet or non-sweet breakfasts for three consecutive weeks, and impacts on food preferences and intakes will be assessed at baseline (day 0), after 1 week (day 7), and after three weeks (day 21).
Preferences for sweet and non-sweet foods will be assessed during two taste tests at each assessment time, where six different foods will be rated.
Sweet and non-sweet food consumption will also be measured at two meals at each assessment time - breakfast and lunch.
Identical buffet meals composed of sweet and non-sweet foods suitable for consumption at breakfast and lunch will be provided ad-libitum.
Intervention breakfasts will only be consumed on the days between test days.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
54
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
US And Canada Only
-
Bournemouth, US And Canada Only, Det Forenede Kongerige, BH12 5BB
- Bournemouth University
-
-
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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- No known food allergy
- No known taste or appetite abnormalities
- Non-smoker
- Habitually eats breakfast
- Able to provide consent and complete all study measures
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: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Sweet food consumption
Sweet breakfasts.
Participants are asked to consume a sweet breakfast every day for three weeks (excepting on three days when outcomes will be assessed (days 0, 7 and 21, day 21 reported).
All foods will be provided.
|
Sweet food consumption at breakfast
|
|
Aktiv komparator: Non-sweet food consumption
Non-sweet breakfasts.
Participants are asked to consume a non-sweet breakfast every day for three weeks (excepting on three days when outcomes will be assessed (days 0, 7 and 21, day 21 reported).
All foods will be provided.
|
Non-sweet food consumption at breakfast
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Food Preferences
Tidsramme: 3 weeks from baseline
|
Ratings of three sweet and three non-sweet foods during a taste test at breakfast.
Ratings measured using 100mm VAS scales for different hedonic factors - pleasure, sweetness, desire to eat).
Scores range from 0-100 where 0=least and 100=greatest for each hedonic factor.
Assessments made on Day 0, 7 and 21, Day 21 reported.
|
3 weeks from baseline
|
|
Food Intake
Tidsramme: 3 weeks from baseline
|
Amount of sweet and non-sweet foods consumed during breakfast on test days (days 0, 7 and 21, day 21 reported)
|
3 weeks from baseline
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Hunger Ratings
Tidsramme: 3 weeks from baseline
|
Ratings of subjective perceptions (two meals).
Ratings measured using 100mm VAS scales for different subjective factors - hunger, thirst, fullness.
Scores range from 0-100 where 0=least and 100=greatest for each subjective factor.
Assessments made on Day 0, 7 and 21, Day 21 reported.
|
3 weeks from baseline
|
|
Food Preferences at Lunch
Tidsramme: 3 weeks from baseline
|
Ratings of three sweet and three non-sweet foods during a taste test at lunch.
Measures are the same as those used at breakfast.
Ratings measured using 100mm VAS scales for different hedonic factors - pleasure, sweetness, desire to eat).
Scores range from 0-100 where 0=least and 100=greatest for each hedonic factor.
Assessments made on Day 0, 7 and 21, Day 21 reported.
|
3 weeks from baseline
|
|
Food Intake at Lunch
Tidsramme: 3 weeks from baseline
|
Amount of sweet and non-sweet foods consumed during lunch on test days (days 0, 7 and 21, day 21 reported).
|
3 weeks from baseline
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
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)
23. februar 2018
Primær færdiggørelse (Faktiske)
31. marts 2020
Studieafslutning (Faktiske)
31. marts 2020
Datoer for studieregistrering
Først indsendt
1. februar 2018
Først indsendt, der opfyldte QC-kriterier
21. februar 2018
Først opslået (Faktiske)
22. februar 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
23. september 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. september 2020
Sidst verificeret
1. september 2020
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- KAPR2018
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
The full study protocol is currently available from the PI on reasonable request.
All generated data will be available from the PI, following completion and publication of the work on reasonable request.
IPD-delingstidsramme
Data will be available following completion and publication of the study.
Data will be stored for ten years following publication of the work.
IPD-delingsadgangskriterier
Direct contact and reasonable request of the PI.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Sweet food consumption
-
University of AberdeenRekrutteringKostændring | Bæredygtigt fødevareforbrugDet Forenede Kongerige
-
Purdue UniversityAfsluttetJernmangel | A-vitamin mangelSenegal
-
International Centre for Diarrhoeal Disease Research...Washington University School of MedicineUkendtErnæring | Mikrobiota | Supplerende madBangladesh
-
Rutgers, The State University of New JerseyAfsluttetMiljøeksponering | Udvalg af madForenede Stater
-
The Affiliated Nanjing Drum Tower Hospital of Nanjing...RekrutteringEsophagogastric Junction CarcinomKina
-
The Miriam HospitalNational Institute of General Medical Sciences (NIGMS)AfsluttetBetændelse | Fødevareusikkerhed | Fedme, barndom | Mentalt helbredForenede Stater
-
Ohio State UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)RekrutteringDiabetes mellitus, type 2 | Dårlig ernæring | MadmangelForenede Stater
-
University of British ColumbiaAfsluttetHusholdningernes fødevaresikkerhedCambodja
-
Pacific Cancer CareAfsluttetProstatakræftForenede Stater