The Effect of Oat Based Breakfast Cereals on Satiety and Food Intake
17. desember 2015 oppdatert av: Frank Greenway, Pennington Biomedical Research Center
The Effect of Oat Based Breakfast Cereals on Satiety and Food Intake.
This study is to determine if two breakfasts of equivalent calories, an oat based breakfast cereal or a ready-to-eat cereal, provide the same satiety benefits.
The study will also determine if the two calorically equivalent oat-based breakfast cereals give different caloric intakes at a lunch meal that participants will eat to their satisfaction.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
The Second trial (Period 2): An additional 48 healthy men and women 18 years of age or older will be enrolled to investigate the satiety and food intake at lunch after a breakfast consisting of one of two randomly assigned oat-based cereals and milk breakfast.
Visual analogue scales of hunger and satiety will be completed before breakfast and at, 30, 60, 120, 180, and 240 minutes following consumption.
Subjects will be asked to eat Lunch until satisfied.
The subjects will have the two breakfasts in a balanced and random order and the two meal tests will be separated by at least a week.
Studietype
Intervensjonell
Registrering (Faktiske)
47
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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Louisiana
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Baton Rouge, Louisiana, Forente stater, 70808
- Pennington Biomedical Research 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
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- 18 years of age or older and are healthy.
- Taking no regular medications other than birth control or hormone replacement therapy.
- Are willing to use an effective method of birth control if you are capable of bearing children. Acceptable methods include abstinence, barrier methods, intrauterine devices, and hormonal methods of contraception.
Exclusion Criteria:
- Are a woman who is pregnant or nursing a baby.
- Have gained or lost 8.8 pounds or more in the last 3 months.
- Have diabetes or a fasting blood sugar over 126 mg/dL.
- Have a score of 14 or greater on the restraint scale of the 3-factor eating questionnaire (a questionnaire which will be given to you by the study staff).
- Are allergic to oats, lactose-free milk, Honey Nut Cheerios or oatmeal.
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: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Test cereal 1, Oat-based
The purpose of this arm is to determine if a breakfast containing 250 kcal of Oat based cereal will cause people to eat less at lunch.
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The study design is a lunch that will be presented 4 hours after the start of breakfast.
Subjects will be asked to eat until satisfied and food intake will will be measured.
The effect on hunger and satiety will be measured using visual analog scales before breakfast and at 30, 60, 120, 180, and 240 minutes following consumption.
The study design is a two visit trial with each subject randomly receiving one of the cereals at each visit separated by at least a week.
A lunch will be presented 4 hours after the start of breakfast.
Subjects will be asked to eat until satisfied and food intake will be measured.
The effect on hunger and satiety will be measured using visual analog scales before breakfast and at 30, 60, 120, 180, and 240 minutes following consumption.
|
|
Eksperimentell: Test Cereal 2, Oat based
The purpose of this arm is to determine if a breakfast containing 250 kcal of Oat based ready-to-eat cereal will cause people to eat less at lunch.
|
The study design is a lunch that will be presented 4 hours after the start of breakfast.
Subjects will be asked to eat until satisfied and food intake will will be measured.
The effect on hunger and satiety will be measured using visual analog scales before breakfast and at 30, 60, 120, 180, and 240 minutes following consumption.
The study design is a two visit trial with each subject randomly receiving one of the cereals at each visit separated by at least a week.
A lunch will be presented 4 hours after the start of breakfast.
Subjects will be asked to eat until satisfied and food intake will be measured.
The effect on hunger and satiety will be measured using visual analog scales before breakfast and at 30, 60, 120, 180, and 240 minutes following consumption.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Satiety Impact
Tidsramme: Baseline to 2 days
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Breakfast containing 250 kcal of Oat-based breakfast cereal will cause people to eat less at lunch compared to a breakfast containing 250 kcal of the ready-to-eat oat-based breakfast cereal.
Area under the curve (AUC) of appetite and satiety.
|
Baseline to 2 days
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Impact on food intake at lunch
Tidsramme: Baseline to 2 days
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You will fill out a visual analog scales at 30, 60, 120, 180, and 240 minutes following the start of the breakfast meal each day. Four hours after the start of breakfast, you will be presented with a lunch and will be asked to eat to your satisfaction over 20 minutes. You will be asked how you are feeling periodically throughout the test. Area under the curve for subjective energy measures |
Baseline to 2 days
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
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
1. august 2012
Primær fullføring (Faktiske)
1. juni 2013
Studiet fullført (Faktiske)
1. juli 2013
Datoer for studieregistrering
Først innsendt
14. august 2012
Først innsendt som oppfylte QC-kriteriene
14. august 2012
Først lagt ut (Anslag)
16. august 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
18. desember 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. desember 2015
Sist bekreftet
1. desember 2015
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- PBRC 12029 (Period 2)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .