The Benefits of Consuming Hummus as an Afternoon Snack
30. dubna 2019 aktualizováno: Heather Leidy, Purdue University
The Benefits of Consuming Hummus as an Afternoon Snack on Appetite Control, Daily Food Intake, and Diet Quality in Adults
The investigators propose a randomized snack study in normal to overweight adults that will test whether the consumption of different afternoon snacks will have different effects on appetite, mood, blood sugar control, and food intake.
Aim 1: To examine whether the addition of hummus as part of an afternoon snack will improve diet quality, particularly through assessments of daily:
- Vegetable consumption
- Snacking behavior
- Energy intake
- Food choices
Aim 2: To examine whether the addition of hummus as part of an afternoon snack will improve appetite control and satiety including assessments of:
- Appetite Control (hunger, desire to eat, prospective food consumption)
- Cravings (sweet, salty, savory)
- Satiety (fullness)
- Eating initiation
Aim 3: To examine whether the addition of hummus as part of an afternoon snack will improve free-living glycemic control.
Aim 4: To explore whether the addition of hummus as part of an afternoon snack will improve mood/energy states
Přehled studie
Detailní popis
Experimental Design: For 6 consecutive days/treatment, the participants will consume either hummus and pretzels, granola bars, or no snack between 2-4 pm and refrain from eating anything else during this time.
On day 7, the participants will consume a standard breakfast, at home, and will come in to the investigator's facility 1 h prior to their habitual lunch time.
The participants will be placed in a comfortable room, void of all time cues and a standardized lunch will be consumed.
At 3 h after lunch, the participants will complete baseline appetite, satiety, and mood questionnaires.
The respective snack will be given to the participants, and they will have 20 minutes to eat the snack.
Snack palatability will also be assessed.
The participants will continue to complete the previous questionnaires until they voluntarily choose to eat (again).
At 3 h after snack, they will be presented with ad libitum dinner and evening snacks.
They will be permitted to eat as much or as little as they would like to eat over the remainder of the day.
In addition, from day 3 to day 8 of the testing week, continuous glucose monitoring will be completed to assess glucose control.
Typ studie
Intervenční
Zápis (Aktuální)
33
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Indiana
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West Lafayette, Indiana, Spojené státy, 47907
- Purdue University
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 50 let (Dospělý)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- normal to overweight (BMI: 18-32 kg/m2)
- no metabolic, psychological, or neurological diseases/conditions not currently or previously on a weight loss or other special diet (in the past 6 months)
- non-smoking
- not been clinically diagnosed with an eating disorder
- habitually eat an afternoon snack between 2:00-4:00 pm
- no food allergies related to the study snacks
- rates the overall liking of hummus higher than "Neither Like nor Dislike" on the screening palatability questionnaire.
Exclusion Criteria:
- Clinically diagnosed with an eating disorder
- Metabolic, hormonal, and/or neural conditions/diseases that influence metabolism or appetite
- Currently or previously on a weight loss or other special diet (in the past 6 months)
- Gained/lost >10 lb. over the past 6 months
- Taking medication that would directly influence appetite (weight-loss drugs or antidepressant, steroid, or thyroid medication, unless dosage has been stable for at least 6 months)
- Not willing or able to complete all study testing procedures
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Snack
The study participants will be provided with a snack to consume every day of the week.
The energy content of the snacks will be standardized to ~240 kcal.
The snacks will have different levels of protein, fat, carbohydrates, sugar, and fiber.
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Hummus and Pretzels- The study participants will be provided with a hummus and pretzels snack to consume every day for a week. The energy content of the hummus and pretzels will be ~240 kcal. The hummus and pretzels contain 6 g protein, 27 g carbohydrates, 0 g sugar, 4 g fiber, and 12 g fat. Granola Bars- The study participants will be provided with two granola bars to consume every day for a week. The energy content of the two granola bars will be ~240 kcal. The two granola bars contain 4 g protein, 38 g carbohydrates, 16 g sugar, 2 g fiber, and 9 g fat. |
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Komparátor placeba: No Snack
The study participants will not be provided with any snack and will be told to consume nothing from 2-4pm for a week.
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The study participants will not be provided with any snack and will be told to consume nothing from 2-4pm for a week.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Perceived Hunger
Časové okno: -180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
|
A questionnaire assessing perceived hunger will be completed at specific times throughout each of the the 6-h testing days.
The questionnaire contains a 100 mm VAS incorporating a horizontal line rating scale for each response.
The questions are worded as "how strong is your feeling of" with anchors of "not all" to "extremely."
The range is 0 mm (min) to 100 (max).
A summation (area under the curve) will be calculated.
Snacks were consumed at +0 min.
|
-180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
|
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Perceived Fullness
Časové okno: -180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
|
A questionnaire assessing perceived fullness will be completed at specific times throughout each of the the 6-h testing days.
The questionnaire contains a 100 mm VAS incorporating a horizontal line rating scale for each response.
The questions are worded as "how strong is your feeling of" with anchors of "not all" to "extremely."
The range is 0 mm (min) to 100 (max).
A summation (area under the curve) will be calculated.
Snacks were consumed at +0 min.
|
-180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
|
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Perceived Desire to Eat
Časové okno: -180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
|
A questionnaire assessing perceived desire to eat will be completed at specific times throughout each of the the 6-h testing days.
The questionnaire contains a 100 mm VAS incorporating a horizontal line rating scale for each response.
The questions are worded as "how strong is your feeling of" with anchors of "not all" to "extremely."
The range is 0 mm (min) to 100 (max).
A summation (area under the curve) will be calculated.
Snacks were consumed at +0 min.
|
-180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
|
|
Perceived Prospective Food Consumption
Časové okno: -180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
|
A questionnaire assessing how much food could be consumed will be completed at specific times throughout each of the the 6-h testing days.
The questionnaire contains a 100 mm VAS incorporating a horizontal line rating scale for each response.
The questions are worded as "how strong is your feeling of" with anchors of "not all" to "extremely."
The range is 0 mm (min) to 100 (max).
A summation (area under the curve) will be calculated.
Snacks were consumed at +0 min.
|
-180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Perceived Sweet
Časové okno: -180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
|
A questionnaire assessing perceived sweet cravings will be completed at specific times throughout each of the the 6-h testing days.
The questionnaire contains a 100 mm VAS incorporating a horizontal line rating scale for each response.
The questions are worded as "how strong is your feeling of" with anchors of "not all" to "extremely."
The range is 0 mm (min) to 100 (max).
A summation (area under the curve) will be calculated.
Snacks were consumed at +0 min.
|
-180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
|
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Perceived Salty
Časové okno: -180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
|
A questionnaire assessing perceived salty cravings will be completed at specific times throughout each of the the 6-h testing days.
The questionnaire contains a 100 mm VAS incorporating a horizontal line rating scale for each response.
The questions are worded as "how strong is your feeling of" with anchors of "not all" to "extremely."
The range is 0 mm (min) to 100 (max).
A summation (area under the curve) will be calculated.
Snacks were consumed at +0 min.
|
-180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
|
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Perceived Savory
Časové okno: -180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
|
A questionnaire assessing perceived savory cravings will be completed at specific times throughout each of the the 6-h testing days.
The questionnaire contains a 100 mm VAS incorporating a horizontal line rating scale for each response.
The questions are worded as "how strong is your feeling of" with anchors of "not all" to "extremely."
The range is 0 mm (min) to 100 (max).
A summation (area under the curve) will be calculated.
Snacks were consumed at +0 min.
|
-180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
|
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Perceived Sleepiness
Časové okno: -180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
|
A questionnaire assessing perceived sleepiness will be completed at specific times throughout each of the the 6-h testing days.
The questionnaire contains a 100 mm VAS incorporating a horizontal line rating scale for each response.
The questions are worded as "how strong is your feeling of" with anchors of "not all" to "extremely."
The range is 0 mm (min) to 100 (max).
A summation (area under the curve) will be calculated.
Snacks were consumed at +0 min.
|
-180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
|
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Perceived Energy
Časové okno: -180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
|
A questionnaire assessing perceived energy state will be completed at specific times throughout each of the the 6-h testing days.
The questionnaire contains a 100 mm VAS incorporating a horizontal line rating scale for each response.
The questions are worded as "how strong is your feeling of" with anchors of "not all" to "extremely."
The range is 0 mm (min) to 100 (max).
A summation (area under the curve) will be calculated.
Snacks were consumed at +0 min.
|
-180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
|
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Perceived Alertness
Časové okno: -180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
|
A questionnaire assessing perceived alertness will be completed at specific times throughout each of the the 6-h testing days.
The questionnaire contains a 100 mm VAS incorporating a horizontal line rating scale for each response.
The questions are worded as "how strong is your feeling of" with anchors of "not all" to "extremely."
The range is 0 mm (min) to 100 (max).
A summation (area under the curve) will be calculated.
Snacks were consumed at +0 min.
|
-180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
|
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Ad libitum Snack Pack-out
Časové okno: 3 testing days
|
Free-living energy intake will be assessed on the in-clinic testing day of each treatment.
When the participant leaves the testing facility, the participant will be provided with an excess of snacks to consume, ad libitum, throughout the remainder of the day.
The quantity of food provided will be ~50% more than their estimated, weight-maintaining energy intake.
All food items will be initially weighed and recorded.
The participants will be instructed to return all uneaten foods as well as all wrappers and containers from consumed food.
Any partially eaten, returned items will be weighed accordingly.
The daily energy content will be assessed from these pack-outs.
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3 testing days
|
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Glucose Excursions Change
Časové okno: 6 days for each treatment
|
Free-living, glucose measures will be performed for 7 consecutive days using Continuous Glucose Monitoring Device.
The participants will report to our facility during one afternoon for insertion.
A small area on the participant's abdomen will be cleaned and the tiny glucose sensor will be inserted just under the skin and held in place with Tegederm.
The sensor measures glucose every 10sec and records an average glucose value every 5min for up to 144h.Calibration is performed by 4 finger sticks/d with a glucose analyzer.
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6 days for each treatment
|
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Perceived Snack Palatability
Časové okno: 2 testing days that include snacks
|
A questionnaires assessing how much the snack is liked will be completed at specific times throughout the 4-h testing days.
The questionnaire contains a 100 mm VAS incorporating a horizontal line rating scale for each response.
The questions are worded as "how strong is your feeling of" with anchors of "not all" to "extremely."
The range is 0 mm (min) to 100 (max).
A summation (area under the curve) will be calculated.
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2 testing days that include snacks
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Heather J Leidy, PhD, Purdue University
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
8. června 2018
Primární dokončení (Aktuální)
20. prosince 2018
Dokončení studie (Aktuální)
20. prosince 2018
Termíny zápisu do studia
První předloženo
30. června 2018
První předloženo, které splnilo kritéria kontroly kvality
11. července 2018
První zveřejněno (Aktuální)
23. července 2018
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
2. května 2019
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
30. dubna 2019
Naposledy ověřeno
1. dubna 2019
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- 1804020480
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Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
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