- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01490034
Effects of Learning and Food Form on Intake in Humans
Due to the rising incidence of obesity, much emphasis has been placed on identifying mechanisms of increased energy intake. At this point, the mechanisms responsible for the recent increase in obesity prevalence have not been thoroughly examined. Pre-ingestive influences, such as cognitive factors, may play a larger role in creating an energy surplus than previously thought. Expectations about the satiating effect of a food may override the post-ingestive influences in dictating further consumption. In addition, obese individuals may exhibit a decreased compensatory response to foods as compared to lean individuals.
Understanding the effects of energy content, food form, and learning on satiation, satiety, and energy intake will allow for a greater understanding of the mechanisms of energy imbalance as a whole. Food choice is dictated by sensory properties and post-ingestive effects. By utilizing foods with similar sensory properties, the acquired knowledge derived from ingesting these foods can be monitored by analyzing subsequent intake at the same meal and at subsequent eating occurrences. It is hypothesized that the liquid food form will elicit weaker dietary compensation; that is, energy intake at other eating events will not be adjusted to compensate for that food. In addition, it is posited that the lower energy food will cause lower compensation postprandially. By having participants consume the same test food daily over a two week learning period, it is thought that they will show improved dietary compensation when the initial testing is repeated due to learned associations between food properties and metabolism.
Přehled studie
Postavení
Podmínky
Detailní popis
Typ studie
Zápis (Očekávaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Indiana
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W. Lafayette, Indiana, Spojené státy, 47907
- Purdue Univeristy
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Weight stable (<3 kg weight change within last 3 months)
- Constant habitual activity patterns (no deviation > 1x/wk at 30 min/session within last 3 months)
- Constant habitual diet patterns within last 3 months
- Willingness to eat a chocolate-flavored snack at test sessions and two week training period
- No allergies to any test foods
- Not planning to change use of medications known to influence appetite or metabolism
- Not diabetic
- No history of GI pathology
- Non-smoker for one year or more
Exclusion Criteria:
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Základní věda
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Energy dense beverage
Metabolic effects of consuming energy dense beverages before and after regular consumption
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Consumption of energy dense beverages for 2 weeks and monitoring physiological responses
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Experimentální: Energy dense solid food form
Metabolic effects of consuming energy dense solid foods before and after regular exposure.
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Effects of consuming energy dense solid food for two weeks on physiological responses
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Experimentální: Eenergy dilute beverages
Metabolic effects of consumption of energy dilute beverages on a regular basis.
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Effects of consuming energy dilute beverages for two weeks on physiological responses.
|
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Experimentální: Energy dilute solid food form
Metabolic effects of consuming energy dilute sold foods before and after regular exposure.
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Effects of consuming energy dilute solid food for two weeks on physiological responses
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
energy intake
Časové okno: 12 weeks
|
Energy consumed over 12 weeks of intervention.
|
12 weeks
|
|
dietary compensation
Časové okno: 12 weeks
|
spontaneous dietary adjustment in response to intervention
|
12 weeks
|
|
appetite
Časové okno: 12 weeks
|
Effects of intervention on appetitive sensation such as hunger and fullness
|
12 weeks
|
|
effects of learning on energy intake
Časové okno: 12 weeks
|
The effects of learning based on exposure to products that are high or low in energy and liquid or solid
|
12 weeks
|
|
Effects of food form on energy intake
Časové okno: 12 weeks
|
The effects of food form on energy intake before and after chronic exposure to foods varying in food form and energy density
|
12 weeks
|
|
Effects of BMI on sensory learning
Časové okno: 12 weeks
|
The effects of BMI on appetite, energy intake and dietary compensation
|
12 weeks
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Effects of personality traits on appetite, energy intake and compensation
Časové okno: 12 weeks
|
Effects of personality traits related to feeding on appetite, energy intake and compensation following exposure to foods of different physical form, energy density and before and after learning.
|
12 weeks
|
Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- R01DK079913-3
- R01DK079913 (Grant/smlouva NIH USA)
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