Appetitive BehaviorNCT03595462
The Benefits of Consuming Hummus as an Afternoon Snack
A study testing Snack and No Snack in people with Appetitive Behavior, run by Purdue University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Appetitive Behavior
- What is being tested?
- Snack and No Snack
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2018to 20 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
- 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
Read the detailed description
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.
- Conditions
- Appetitive Behavior
- Being tested
- Snack, No Snack
- Medical subject headings
- Appetitive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SnackOther
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.
No SnackOther
The study participants will not be provided with any snack and will be told to consume nothing from 2-4pm for a week.
| Study group | Role | What they receive |
|---|---|---|
| Snack | Experimental | 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. Receives: Other: Snack |
| No Snack | Placebo comparator | The study participants will not be provided with any snack and will be told to consume nothing from 2-4pm for a week. Receives: Other: No Snack |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: -180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
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.
Measured: -180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
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.
Measured: -180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
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.
Measured: -180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
Secondary outcomes (9)
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.
Measured: -180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
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.
Measured: -180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
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.
Measured: -180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
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.
Measured: -180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
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.
Measured: -180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min
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.
Measured: -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
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.
Measured: 3 testing days
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.
Measured: 6 days for each treatment
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.
Measured: 2 testing days that include snacks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start8 Jun 2018
- Primary completion20 Dec 2018
- Study completion20 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appetitive BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- tightly-controlled, randomized cross-over design
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heather Leidy, Purdue University
- Investigators
- Heather J Leidy, PhD, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03595462
- Sponsor's protocol ID
- 1804020480
- Status last verified
- Apr 2019
- First submitted
- 30 Jun 2018
- Last updated
- 2 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Benefits of Consuming Hummus as an Afternoon Snack on Appetite Control, Daily Food Intake, and Diet Quality in Adults
- ClinicalTrials.gov ID
- NCT03595462
- Acronym / sponsor ID
- 1804020480
- Conditions
- Appetitive Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- 8 Jun 2018 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 23 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- tightly-controlled, randomized cross-over design
| Arm | Type | Receives |
|---|---|---|
| Snack | Experimental | Other: SnackThe 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. |
| No Snack | Placebo comparator | Other: No SnackThe study participants will not be provided with any snack and will be told to consume nothing from 2-4pm for a week. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SnackHummus 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. | Other | Snack |
| No SnackThe study participants will not be provided with any snack and will be told to consume nothing from 2-4pm for a week. | Other | No Snack |
Primary outcome
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.
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.
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.
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.
9 secondary outcomes
Perceived Sweet
Time frame: -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
Perceived Savory
Time frame: -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
Perceived Energy
Time frame: -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
Ad libitum Snack Pack-out
Time frame: 3 testing days
Glucose Excursions Change
Time frame: 6 days for each treatment
Perceived Snack Palatability
Time frame: 2 testing days that include snacks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather J Leidy, PhD principal investigator
Purdue University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Snack and No Snack in people with Appetitive Behavior, run by Purdue University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Hunger (time frame: -180 min, -120 min, -60 min, +0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2019.