- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03595462
The Benefits of Consuming Hummus as an Afternoon Snack
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Indiana
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West Lafayette, Indiana, United States, 47907
- Purdue University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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. |
Placebo Comparator: 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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived Hunger
Time Frame: -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
Time Frame: -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
Time Frame: -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
Time Frame: -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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived Sweet
Time Frame: -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
Time Frame: -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
Time Frame: -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
Time Frame: -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
Time Frame: -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
Time Frame: -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
Time Frame: 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
|
Glucose Excursions Change
Time Frame: 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
Time Frame: 2 testing days that include snacks
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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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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Heather J Leidy, PhD, Purdue University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1804020480
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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