ObesityNCT01781286
The Beneficial Effects of Healthy Snacks on Appetite Control, Satiety, and Reward-driven Eating Behavior in Young People
A study testing High Protein and Low Protein in people with Obesity, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
The purpose of this study is to examine the effects of normal vs. protein-rich afternoon snacks on appetite control, satiety, and reward-driven eating (particularly in the evening) in young people. Indices of attention and mood will also be assessed. Study hypotheses include the following: 1. Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- High Protein and Low Protein
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jan 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 13 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age range 13-19 years
- Normal to overweight (BMI: 50-85th percentile for BMI for age or BMI: 18-29.9 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)
- Not clinically diagnosed with an eating disorder
- Habitually eat (i.e., at least 5 times/week) breakfast between 7:00-9:00 am, lunch between 11:00 am-1:00 pm, an afternoon snack between 2:00-4:00 pm, and dinner
Show all 9Show fewer
- No food allergies or intolerances to soy products
- Rates the overall liking of the study snack foods higher than "Neither Like nor Dislike" on the screening palatability questionnaire
- Right handed
Who cannot join
- Age 12 years or younger, or 20 years or older
- Underweight or Obese (below 50th or above 85th percentile for BMI for age, or BMI below 18 or above 29.9 kg/m2)
- Any metabolic, psychological, or neurological diseases/conditions
- Currently or previously on a weight loss or other special diet (in the past 6 months)
- Clinically diagnosed with an eating disorder
- Does not habitually eat (i.e., at least 5 times/week) breakfast between 7:00-9:00 am, lunch between 11:00 am-1:00 pm, an afternoon snack between 2:00-4:00 pm, and dinner
Show all 9Show fewer
- Food allergies or intolerances to soy products
- Does not rate the overall liking of the study snack foods higher than "Neither Like nor Dislike" on the screening palatability questionnaire
- Not right handed
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri-Columbia
Columbia, Missouri, 65211
About this study
Official title: The Beneficial Effects of Protein-rich, Afternoon Snacks on Appetite Control, Satiety, and Reward-driven Eating Behavior in Young People
The purpose of this study is to examine the effects of normal vs. protein-rich afternoon snacks on appetite control, satiety, and reward-driven eating (particularly in the evening) in young people. Indices of attention and mood will also be assessed.
Study hypotheses include the following:
- The consumption of a high-protein, soy-rich afternoon snack will lead to significant improvements in appetite control and satiety, reductions in food motivation and reward, and will delay the drive to eat in normal to overweight young people.
- The consumption of a high-protein, soy-rich afternoon snack will lead to reduced unhealthy, evening snacking, particularly on foods high in fat and/or sugar, in normal to overweight young people.
- The daily consumption of a high-protein, soy-rich afternoon snack will lead to significant improvements in afternoon alertness, concentration, fatigue, and well-being in normal to overweight young people.
Read the detailed description
Forty adolescents will participate in the following randomized crossover-design study. Prior to the start of the study, the participants will be asked to document their habitual breakfast, lunch, and afternoon snack times. The snack patterns and associated testing days will be scheduled so that each participant consumes the afternoon snack (or refrains from snacking) 3 hours after lunch; however, the time of day when this occurs is based on the participant's previous, habitual snack time. Once this is determined, each participant will randomly acclimate to the following snack pattern for 3 consecutive days: 1) Higher Protein Soy-based Snacks (250 kcal; 40% Protein; 40% Carbohydrates; 20% Fat); 2) Typical, Low Protein Snacks (5% Protein; 50% Carbohydrates; 45% Fat); and 3) No Snack.
On day 4, the participants will consume a standard breakfast, at home, and lunch, at school, and will come in to our facility 1 hour prior to their habitual snack time. The participants will be placed in a window-less, comfortable room, void of all time cues. They will be informed that they will remain in this room for the next 6 hours. The participants will begin the testing day by completing baseline questionnaires assessing appetite, satiety, mood, and cognitive function. A brain scan will be completed using functional magnetic resonance imaging (fMRI) to identify brain activation patterns in response to food stimuli. Following the fMRI scan, the respective snack will be given to the participants; they will have 15 minutes to eat the snack. A second fMRI scan will then be performed. The participants will continue to complete the previous questionnaires until they voluntarily choose to eat. At this time, the volunteers will be presented with an 'all you can eat' snack buffet. They will be permitted to eat as much or as little as they would like to eat over the next 3-hour period. The participants will remain in the facility until the full 8-hour testing day is completed, regardless of when they requested to eat. Following the 6 hours, the participants will be permitted to leave the facility.
- Conditions
- Obesity
- Being tested
- High Protein, Low Protein
- Keywords
- Obesity, Snacking, Appetite, Protein, Soy, Reward driven eating, Satiety
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High ProteinBehavioural
250 kcal; 40% Protein; 40% Carbohydrate; 20% Fat
Low ProteinBehavioural
5% Protein; 50% Carbohydrates; 45% Fat
| Study group | Role | What they receive |
|---|---|---|
| High Protein | Active comparator | Higher Protein Soy-based Snacks Receives: Behavioral: High Protein |
| Low Protein | Active comparator | Typical, Low Protein Snacks Receives: Behavioral: Low Protein |
| No Snack | No intervention | No Snack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Dinner Request
The participants will be asked whether they would like to request a dinner buffet throughout the 5 h post-snack period. When the response is "Yes, I want to eat right now", the time from snack consumption will be recorded.
Measured: 1 Day
Secondary outcomes (5)
Appetite Questionnaires
Computerized questionnaires, assessing perceived sensations of appetite will be completed throughout the testing days. The questionnaires contain visual analog scales incorporating a 100 mm horizontal line rating scale for each response. The questions are worded as "how strong is your feeling of" with anchors of "not all" (scored as 0 out of 100) to "extremely" (scored as 100 out of 100). The following questions will be incorporated as 1 composite score ((Questions 1 + 3 + 4 - 2)/4) multiplied by the 300 minutes (a max of 30,000 mm*min and a minimum of -30,000 mm*min):
- How strong is your feeling of hunger?
- How strong is your feeling of being full?
- How strong is your desire to eat?
- How much food could you consume right now?
The Adaptive Visual Analog Scale Software (Neurobehavioral Research Laboratory and Clinic; San Antonio, TX) was used for these assessments.
Measured: 0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min, +270 min, +300 min
Snack Palatability and Perception Questionnaires
Computerized questionnaires, assessing snack palatability and perceptions of the snack will be completed during screening and after the first and last bite of each snack during the acclimation and testing days. The questionnaires contain visual analog scales incorporating a 100 mm horizontal line rating scale for each response. The questions are worded as "how strong is your feeling of" with anchors of "not all" (scores 0 out of 100) to "extremely" (scores 100 out of 100). The questions assess snack appearance, smell, flavor, texture (feel), liking.
The Adaptive Visual Analog Scale Software (Neurobehavioral Research Laboratory and Clinic; San Antonio, TX) was used for these assessments.
Measured: 5 min
Attention & Memory Questionnaires
Cognitive function will be assessed immediately before (-30 min) and 60 min post-snack using the lap-top based Cantab® computerized assessment system. This program consisted of a core battery of tests grouped into main categories including 1) Working Memory; 2) Reasoning; 3) Executive Function; 4) Reaction Time; 5) Sustained Attention; 6) Cognitive Flexibility; and 7) Processing Speed. This program has been used in our previous breakfast studies with success. A greater raw score for working memory, reasoning, executive function, sustained attention, and cognitive flexibility is considered to be greater performance. A lower score for reaction time and processing speed is considered to be greater performance. The raw scores are determined by Cantab® computerized assessment system. Therefore, maximum and minimum values for each test are unknown.
Measured: 90 min
Mood-state Questionnaires
Indices of mood state will be assessed immediately before and 60 min post-snack using the on-line, Profile of Mood States, 2nd Edition (POMS2). This program consisted of a core battery of tests with the following sub-categories 1) Tension; 2) Depression; 3) Anger; 4) Vigor; 5) Fatigue; 6) Confusion; and 7) Friendliness. Outcomes are scored as a T-score which could be a minimum of zero with no upper limit. A lower score represents a more positive mood state and a higher score represents a more negative mood state.
Measured: -30 min, +60 min
Energy Intake
Post-snack energy intake will be assessed through ad libitum dinner and snacking assessments. The ad libitum dinner will contain approximately 2,000 kcal and will consist of a chicken, rice, and stir-fry meal, chips, chocolate mints, ice tea, and water. The dinner meal will be consumed in the testing facility. The participants will be instructed to eat as much as or as little as they choose over a 30 min period. All contents will be weighed before the dinner and any remains will be re-weighed afterwards to determine the type and quantity of foods consumed.
The ad libitum evening snacks will contain 3,000 kcal and will include common snack foods. After the testing day is complete, the participants will take the snack packout home and consume any of the foods he/she chooses until going to bed. All contents will be weighed before the packout and any remains will be re-weighed afterwards to determine the type and quantity of foods consumed.
Measured: +300 min, 24 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionOct 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Solae, LLC
- Responsible party
- Principal investigator, Heather Leidy, University of Missouri-Columbia
- Investigators
- Heather J Leidy, PhD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01781286
- Sponsor's protocol ID
- 00039414
- Status last verified
- Jul 2018
- First submitted
- 9 Jan 2013
- Last updated
- 23 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Leidy HJ, Todd CB, Zino AZ, Immel JE, Mukherjea R, Shafer RS, Ortinau LC, Braun M. Consuming High-Protein Soy Snacks Affects Appetite Control, Satiety, and Diet Quality in Young People and Influences Select Aspects of Mood and Cognition. J Nutr. 2015 Jul;145(7):1614-22. doi: 10.3945/jn.115.212092. Epub 2015 May 20.
PubMed 25995282
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Beneficial Effects of Protein-rich, Afternoon Snacks on Appetite Control, Satiety, and Reward-driven Eating Behavior in Young People
- ClinicalTrials.gov ID
- NCT01781286
- Acronym / sponsor ID
- 00039414
- Conditions
- Obesity
- Keywords
- Obesity, Snacking, Appetite, Protein, Soy, Reward driven eating, Satiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- Solae, LLC
- Study start
- Jan 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 31 Jan 2013 (estimated)
- Results
- Posted 23 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the effects of normal vs. protein-rich afternoon snacks on appetite control, satiety, and reward-driven eating (particularly in the evening) in young people. Indices of attention and mood will also be assessed.
Study hypotheses include the following:
- The consumption of a high-protein, soy-rich afternoon snack will lead to significant improvements in appetite control and satiety, reductions in food motivation and reward, and will delay the drive to eat in normal to overweight young people.
- The consumption of a high-protein, soy-rich afternoon snack will lead to reduced unhealthy, evening snacking, particularly on foods high in fat and/or sugar, in normal to overweight young people.
- The daily consumption of a high-protein, soy-rich afternoon snack will lead to significant improvements in afternoon alertness, concentration, fatigue, and well-being in normal to overweight young people.
Detailed description
Forty adolescents will participate in the following randomized crossover-design study. Prior to the start of the study, the participants will be asked to document their habitual breakfast, lunch, and afternoon snack times. The snack patterns and associated testing days will be scheduled so that each participant consumes the afternoon snack (or refrains from snacking) 3 hours after lunch; however, the time of day when this occurs is based on the participant's previous, habitual snack time. Once this is determined, each participant will randomly acclimate to the following snack pattern for 3 consecutive days: 1) Higher Protein Soy-based Snacks (250 kcal; 40% Protein; 40% Carbohydrates; 20% Fat); 2) Typical, Low Protein Snacks (5% Protein; 50% Carbohydrates; 45% Fat); and 3) No Snack.
On day 4, the participants will consume a standard breakfast, at home, and lunch, at school, and will come in to our facility 1 hour prior to their habitual snack time. The participants will be placed in a window-less, comfortable room, void of all time cues. They will be informed that they will remain in this room for the next 6 hours. The participants will begin the testing day by completing baseline questionnaires assessing appetite, satiety, mood, and cognitive function. A brain scan will be completed using functional magnetic resonance imaging (fMRI) to identify brain activation patterns in response to food stimuli. Following the fMRI scan, the respective snack will be given to the participants; they will have 15 minutes to eat the snack. A second fMRI scan will then be performed. The participants will continue to complete the previous questionnaires until they voluntarily choose to eat. At this time, the volunteers will be presented with an 'all you can eat' snack buffet. They will be permitted to eat as much or as little as they would like to eat over the next 3-hour period. The participants will remain in the facility until the full 8-hour testing day is completed, regardless of when they requested to eat. Following the 6 hours, the participants will be permitted to leave the facility.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Protein | Active comparator | Behavioral: High ProteinHigher Protein Soy-based Snacks |
| Low Protein | Active comparator | Behavioral: Low ProteinTypical, Low Protein Snacks |
| No Snack | No intervention | –No Snack |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Age range 13-19 years
- Normal to overweight (BMI: 50-85th percentile for BMI for age or BMI: 18-29.9 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)
- Not clinically diagnosed with an eating disorder
Key exclusion criteria (9 listed)
- Age 12 years or younger, or 20 years or older
- Underweight or Obese (below 50th or above 85th percentile for BMI for age, or BMI below 18 or above 29.9 kg/m2)
- Any metabolic, psychological, or neurological diseases/conditions
- Currently or previously on a weight loss or other special diet (in the past 6 months)
- Clinically diagnosed with an eating disorder
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 |
|---|---|---|
| High Protein250 kcal; 40% Protein; 40% Carbohydrate; 20% Fat | Behavioural | High Protein |
| Low Protein5% Protein; 50% Carbohydrates; 45% Fat | Behavioural | Low Protein |
Primary outcome
Time to Dinner Request
Time frame: 1 Day
The participants will be asked whether they would like to request a dinner buffet throughout the 5 h post-snack period. When the response is "Yes, I want to eat right now", the time from snack consumption will be recorded.
5 secondary outcomes
Appetite Questionnaires
Time frame: 0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min, +270 min, +300 min
Snack Palatability and Perception Questionnaires
Time frame: 5 min
Attention & Memory Questionnaires
Time frame: 90 min
Mood-state Questionnaires
Time frame: -30 min, +60 min
Energy Intake
Time frame: +300 min, 24 h
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25995282Leidy HJ, Todd CB, Zino AZ, Immel JE, Mukherjea R, Shafer RS, Ortinau LC, Braun M. Consuming High-Protein Soy Snacks Affects Appetite Control, Satiety, and Diet Quality in Young People and Influences Select Aspects of Mood and Cognition. J Nutr. 2015 Jul;145(7):1614-22. doi: 10.3945/jn.115.212092. Epub 2015 May 20.
- Individual participant dataSharing planned: Undecided
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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
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Protein and Low Protein in people with Obesity, run by University of Missouri-Columbia 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 9 inclusion and 9 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 23 Jul 2018. 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. 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?
Yes. Results are posted in the registry (first posted 23 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time to Dinner Request (time frame: 1 Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01781286, which also lists 1 linked publication.
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 23 Jul 2018.