The Effect of Oat Based Breakfast Cereals on Satiety and Food Intake
17 december 2015 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Ingrijpend
Inschrijving (Werkelijk)
47
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Louisiana
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Baton Rouge, Louisiana, Verenigde Staten, 70808
- Pennington Biomedical Research Center
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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.
|
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Experimenteel: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Satiety Impact
Tijdsspanne: 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.
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Baseline to 2 days
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Impact on food intake at lunch
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 augustus 2012
Primaire voltooiing (Werkelijk)
1 juni 2013
Studie voltooiing (Werkelijk)
1 juli 2013
Studieregistratiedata
Eerst ingediend
14 augustus 2012
Eerst ingediend dat voldeed aan de QC-criteria
14 augustus 2012
Eerst geplaatst (Schatting)
16 augustus 2012
Updates van studierecords
Laatste update geplaatst (Schatting)
18 december 2015
Laatste update ingediend die voldeed aan QC-criteria
17 december 2015
Laatst geverifieerd
1 december 2015
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- PBRC 12029 (Period 2)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .