The Beneficial Effects of Healthy Snacks on Appetite Control, Satiety, and Reward-driven Eating Behavior in Young People
The Beneficial Effects of Protein-rich, Afternoon Snacks on Appetite Control, Satiety, and Reward-driven Eating Behavior in Young People
1 other identifier
interventional
37
1 country
1
Brief 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.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.
- 2.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.
- 3.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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Jan 2013
Shorter than P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 9, 2013
CompletedFirst Posted
Study publicly available on registry
January 31, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedResults Posted
Study results publicly available
July 23, 2018
CompletedJuly 23, 2018
July 1, 2018
9 months
January 9, 2013
May 2, 2017
July 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1 Day
Secondary Outcomes (5)
Appetite Questionnaires
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
5 min
Attention & Memory Questionnaires
90 min
Mood-state Questionnaires
-30 min, +60 min
Energy Intake
+300 min, 24 h
Study Arms (3)
High Protein
ACTIVE COMPARATORHigher Protein Soy-based Snacks
Low Protein
ACTIVE COMPARATORTypical, Low Protein Snacks
No Snack
NO INTERVENTIONNo Snack
Interventions
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Missouri-Columbialead
- Solae, LLCcollaborator
Study Sites (1)
University of Missouri-Columbia
Columbia, Missouri, 65211, United States
Related Publications (1)
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.
PMID: 25995282DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Menstrual cycle was not controlled for within the female participants. However, menstrual cyclicity varied between testing days and between participants, thus, reducing any systematic bias/effect.
Results Point of Contact
- Title
- Dr. Heather Leidy
- Organization
- University of Missouri
Study Officials
- PRINCIPAL INVESTIGATOR
Heather J Leidy, PhD
University of Missouri-Columbia
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Tenure-track Assistant Professor, Heather J Leidy, PhD
Study Record Dates
First Submitted
January 9, 2013
First Posted
January 31, 2013
Study Start
January 1, 2013
Primary Completion
October 1, 2013
Study Completion
January 1, 2014
Last Updated
July 23, 2018
Results First Posted
July 23, 2018
Record last verified: 2018-07