- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01102907
Effect of Food Form on Satiety and Gastric Emptying
Beverages and Obesity: Effect of Food Form on Satiety and Hunger
Our objective is to determine whether food form (liquid vs. solid) alters gastric emptying, satiety, and food intake, when all macronutrients and fiber are controlled. The study population will include 10 healthy women, who have a normal body mass index. We have chosen to evaluate only women because this is a small pilot study and one of our endpoints is gastric emptying. Gastric emptying is known to differ between men and women. Gastric emptying will be evaluated using the Smartpill technology, satiety will be evaluated using computerized visual analog scales/questions, and food intake will be measured by providing subjects with an ad libitum/buffet-style lunch.
Our hypothesis is that our subjects will be less hungry after they eat a solid breakfast compared to a liquid breakfast. We also hypothesize that our subjects will have a slower gastric emptying time after they eat the solid meal. Lastly, we think subjects will want to eat less food at lunch time if they have eaten a solid meal compared to a liquid meal for breakfast.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
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Minnesota
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Saint Paul, Minnesota, Forente stater, 55108
- University of Minnesota
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Healthy women
- Age 18 - 35
- Body mass index in the healthy range between 18.5 and 25
- Proficient English speakers
- Non-smoking
- Not taking medications
- Non-dieting (weight stable over last 3 months)
- Able to swallow a large capsule
Exclusion Criteria:
- Irregular or erratic breakfast eating patterns
- Food allergies to ingredients commonly found in test products or pizza
- Distaste for test products or pizza
- BMI less than 18.5 or greater than 25
- Weight change > 5 kg in last 3 months (intentional or unintentional)
- Difficulty swallowing
- Cardiovascular disease
- Diabetes mellitus (fasting blood sugar > 126 mg/dl)
- Cancer in prior 5 years (except basal cell carcinoma of skin)
- Kidney or liver disease
- Any gastrointestinal conditions that may affect digestion and absorption
- Recent bacterial infection (< 3 months)
- Chronic medication use
- History of drug or alcohol abuse in prior 6 months
- Concurrent or recent intervention study participation
- Vegetarians or people who ate more than approximately 15 g of fiber per day
- Pregnant or lactating women
- Women with irregular menstrual cycles
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Liquid Meal
|
The liquid breakfast meal will contain 370 calories and will consist of fruit juices and skim milk
|
|
Solid Meal
|
The solid breakfast will contain 370 calories and will consist of oatmeal, golden delicious apples, blueberries, skim milk, and brown sugar.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Determine whether food form (liquid vs. solid) alters gastric emptying time when all macronutrients and fiber are controlled.
Tidsramme: May 2010 to December 2010
|
Subjects will consume both liquid and solid meals and we will evaluate and compare gastric emptying time after each of them.
|
May 2010 to December 2010
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Determine whether food form (liquid vs. solid) alters satiety and food intake when all macronutrients and fiber are controlled.
Tidsramme: May 2010 to December 2010
|
Subjects will consume both liquid and solid meals and we will evaluate and compare appetite and food intake after each of them.
|
May 2010 to December 2010
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Holly J Willis, PhD, University of Minnesota
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 1003M78873
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