Appetitive Behavior Clinical Trial
Official title:
The Benefits of Consuming Hummus as an Afternoon Snack on Appetite Control, Daily Food Intake, and Diet Quality in Adults
Verified date | April 2019 |
Source | Purdue University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 33 |
Est. completion date | December 20, 2018 |
Est. primary completion date | December 20, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Purdue University | West Lafayette | Indiana |
Lead Sponsor | Collaborator |
---|---|
Purdue University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Perceived Hunger | 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 | |
Primary | Perceived Fullness | 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 | |
Primary | Perceived Desire to Eat | 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 | |
Primary | Perceived Prospective Food Consumption | 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 | Perceived Sweet | 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 | |
Secondary | Perceived Salty | 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 | |
Secondary | Perceived Savory | 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 | |
Secondary | Perceived Sleepiness | 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 | |
Secondary | Perceived Energy | 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 | |
Secondary | Perceived Alertness | 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 | |
Secondary | Ad libitum Snack Pack-out | 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 | |
Secondary | Glucose Excursions Change | 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 | |
Secondary | Perceived Snack Palatability | 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 |
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