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The Benefits of Consuming Hummus as an Afternoon Snack

30 aprile 2019 aggiornato da: 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

Panoramica dello studio

Stato

Completato

Condizioni

Comportamento Appetitivo

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

Fase

Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

Stati Uniti
- Indiana
  - West Lafayette, Indiana, Stati Uniti, 47907
    - Purdue University

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 50 anni (Adulto)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Scopo principale: Prevenzione
Assegnazione: Randomizzato
Modello interventistico: Assegnazione incrociata
Mascheramento: Separare

Numero di armi

Armi e interventi

Gruppo di partecipanti / Arm	Intervento / Trattamento
Sperimentale: 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.	Altro: Snack 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.
Comparatore placebo: 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.	Altro: 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.

Gruppo di partecipanti / Arm

Intervento / Trattamento

Sperimentale: 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.

Altro: Snack

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.

Comparatore placebo: 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.

Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Perceived Hunger Lasso di tempo: -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
Perceived Fullness Lasso di tempo: -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
Perceived Desire to Eat Lasso di tempo: -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 Lasso di tempo: -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

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Perceived Sweet Lasso di tempo: -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
Perceived Salty Lasso di tempo: -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
Perceived Savory Lasso di tempo: -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
Perceived Sleepiness Lasso di tempo: -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
Perceived Energy Lasso di tempo: -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
Perceived Alertness Lasso di tempo: -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
Ad libitum Snack Pack-out Lasso di tempo: 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.	3 testing days
Glucose Excursions Change Lasso di tempo: 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.	6 days for each treatment
Perceived Snack Palatability Lasso di tempo: 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.	2 testing days that include snacks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Purdue University

Investigatori

Investigatore principale: Heather J Leidy, PhD, Purdue University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

8 giugno 2018

Completamento primario (Effettivo)

20 dicembre 2018

Completamento dello studio (Effettivo)

20 dicembre 2018

Date di iscrizione allo studio

Primo inviato

30 giugno 2018

Primo inviato che soddisfa i criteri di controllo qualità

11 luglio 2018

Primo Inserito (Effettivo)

23 luglio 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 maggio 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 aprile 2019

Ultimo verificato

1 aprile 2019

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

1804020480

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

The Benefits of Consuming Hummus as an Afternoon Snack