Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Beneficial Effects of Healthy Snacks on Appetite Control, Satiety, and Reward-driven Eating Behavior in Young People

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01781286
Recruitment Status : Completed
First Posted : January 31, 2013
Results First Posted : July 23, 2018
Last Update Posted : July 23, 2018
Sponsor:
Collaborator:
Solae, LLC
Information provided by (Responsible Party):
Heather Leidy, University of Missouri-Columbia

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Obesity
Interventions Behavioral: High Protein
Behavioral: Low Protein
Enrollment 37
Recruitment Details  
Pre-assignment Details  
Arm/Group Title High Fat Snack > No Snack > High Protein Snack High Fat Snack > High Protein Snack > No Snack No Snack > High Protein Snack > High Fat Snack No Snack > High Fat Snack > High Protein Snack High Protein Snack > No Snack > High Fat Snack High Protein Snack > High Fat Snack > No Snack
Hide Arm/Group Description 8 Participants began testing procedures but only 31 completed all procedures. Each participant was randomly acclimated to the following snack patterns for 3 consecutive days: 1) Typical, Low Protein Snacks (5% Protein; 50% Carbohydrates; 45% Fat); 2) No Snack and 3) Higher Protein Soy-based Snacks (250 kcal; 40% Protein; 40% Carbohydrates; 20% Fat). On day 4, participants completed all testing day procedures outlined in the study description. Three participants signed the consent form but never began testing procedures. One dropped out before completing the second testing day and another before the third. Upon completion of all thirty two participants, one was later found to be noncompliant with testing day procedures. 4 Participants began testing procedures but only 31 completed all procedures. Each participant was randomly acclimated to the following snack patterns for 3 consecutive days: 1) Typical, Low Protein Snacks (5% Protein; 50% Carbohydrates; 45% Fat); 2) Higher Protein Soy-based Snacks (250 kcal; 40% Protein; 40% Carbohydrates; 20% Fat) and 3) No Snack. On day 4, participants completed all testing day procedures outlined in the study description. Three participants signed the consent form but never began testing procedures. One dropped out before completing the second testing day and another before the third. Upon completion of all thirty two participants, one was later found to be noncompliant with testing day procedures. 9 Participants began testing procedures but only 31 completed all procedures. Each participant was randomly acclimated to the following snack patterns for 3 consecutive days: 1) No Snack; 2) Higher Protein Soy-based Snacks (250 kcal; 40% Protein; 40% Carbohydrates; 20% Fat) and 3) Typical, Low Protein Snacks (5% Protein; 50% Carbohydrates; 45% Fat). On day 4, participants completed all testing day procedures outlined in the study description. Three participants signed the consent form but never began testing procedures. One dropped out before completing the second testing day and another before the third. Upon completion of all thirty two participants, one was later found to be noncompliant with testing day procedures. 8 Participants began testing procedures but only 31 completed all procedures. Each participant was randomly acclimated to the following snack patterns for 3 consecutive days: 1) No Snack; 2) Typical, Low Protein Snacks (5% Protein; 50% Carbohydrates; 45% Fat and 3) Higher Protein Soy-based Snacks (250 kcal; 40% Protein; 40% Carbohydrates; 20% Fat). On day 4, participants completed all testing day procedures outlined in the study description. Three participants signed the consent form but never began testing procedures. One dropped out before completing the second testing day and another before the third. Upon completion of all thirty two participants, one was later found to be noncompliant with testing day procedures. 6 Participants began testing procedures but only 31 completed all procedures. Each participant was randomly acclimated to the following snack patterns for 3 consecutive days: 1) Higher Protein Soy-based Snacks (250 kcal; 40% Protein; 40% Carbohydrates; 20% Fat); 2) No Snack and 3) Typical, Low Protein Snacks (5% Protein; 50% Carbohydrates; 45% Fat. On day 4, participants completed all testing day procedures outlined in the study description. Three participants signed the consent form but never began testing procedures. One dropped out before completing the second testing day and another before the third. Upon completion of all thirty two participants, one was later found to be noncompliant with testing day procedures. 3 Participants began testing procedures but only 31 completed all procedures. Each participant was randomly acclimated to the following snack patterns 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, participants completed all testing day procedures outlined in the study description. Three participants signed the consent form but never began testing procedures. One dropped out before completing the second testing day and another before the third. Upon completion of all thirty two participants, one was later found to be noncompliant with testing day procedures.
Period Title: Overall Study
Started 7 4 9 8 6 3
Started 1st Intervention 6 4 9 8 6 2
Started 2nd Intervention 5 4 9 8 6 2
Started 3rd Intervention 5 4 7 7 6 2
Completed 5 4 7 7 6 2
Not Completed 2 0 2 1 0 1
Reason Not Completed
Lost to Follow-up             0             0             0             0             0             1
Time Constraints             2             0             2             0             0             0
Noncompliance             0             0             0             1             0             0
Arm/Group Title All Study Participants
Hide Arm/Group Description Each participant was randomly acclimated to the following snack patterns 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, participants completed all testing day procedures outlined in the study description.
Overall Number of Baseline Participants 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants
17  (1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Female
16
  51.6%
Male
15
  48.4%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 31 participants
31
 100.0%
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 31 participants
171  (2)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 31 participants
65.6  (2.1)
BMI (kg/m2)  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 31 participants
22.3  (0.4)
BMI (%)  
Mean (Standard Deviation)
Unit of measure:  Percentile
Number Analyzed 31 participants
58.4  (4.4)
Frequency of Snacking  
Mean (Standard Deviation)
Unit of measure:  Days/week
Number Analyzed 31 participants
6  (1)
Commonly consumed chips/crackers as a snack  
Measure Type: Number
Unit of measure:  % of total participants
Number Analyzed 31 participants
64
Commonly consumed fruit as a snack  
Measure Type: Number
Unit of measure:  % of total participants
Number Analyzed 31 participants
61
Commonly consumed cereal as a snack  
Measure Type: Number
Unit of measure:  % of total participants
Number Analyzed 31 participants
25
1.Primary Outcome
Title Time to Dinner Request
Hide Description 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.
Time Frame 1 Day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Protein High Fat (Low Protein) No Snack
Hide Arm/Group Description:

Higher Protein Soy-based Snacks

High Protein: 250 kcal; 40% Protein; 40% Carbohydrate; 20% Fat

Typical High Fat (Low Protein) Snacks

5% Protein; 50% Carbohydrates; 45% Fat

No snack was received
Overall Number of Participants Analyzed 31 31 31
Mean (Standard Error)
Unit of Measure: minutes
158  (7) 150  (6) 140  (6)
2.Secondary Outcome
Title Appetite Questionnaires
Hide Description

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):

  1. How strong is your feeling of hunger?
  2. How strong is your feeling of being full?
  3. How strong is your desire to eat?
  4. 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.

Time Frame 0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min, +270 min, +300 min
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Protein High Fat (Low Protein) No Snack
Hide Arm/Group Description:

Higher Protein Soy-based Snacks

High Protein: 250 kcal; 40% Protein; 40% Carbohydrate; 20% Fat

Typical, High Fat (Low Protein) Snacks

5% Protein; 50% Carbohydrates; 45% Fat

No snack was received
Overall Number of Participants Analyzed 31 31 31
Mean (Standard Error)
Unit of Measure: mm*min
-5500  (1000) -3000  (1000) 3000  (1000)
3.Secondary Outcome
Title Snack Palatability and Perception Questionnaires
Hide Description

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.

Time Frame 5 min
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Protein High Fat (Low Protein) No Snack
Hide Arm/Group Description:

Higher Protein Soy-based Snacks

High Protein: 250 kcal; 40% Protein; 40% Carbohydrate; 20% Fat

Typical High Fat (Low Protein) Snacks

5% Protein; 50% Carbohydrates; 45% Fat

No snack was received
Overall Number of Participants Analyzed 31 31 31
Mean (Standard Error)
Unit of Measure: millimeters
69  (4) 80  (3) NA [1]   (NA)
[1]
No snack was consumed. Therefore, palatability could not be assessed.
4.Secondary Outcome
Title Attention & Memory Questionnaires
Hide Description 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.
Time Frame 90 min
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Protein High Fat (Low Protein) No Snack
Hide Arm/Group Description:

Higher Protein Soy-based Snacks

High Protein: 250 kcal; 40% Protein; 40% Carbohydrate; 20% Fat

Typical High Fat (Low Protein) Snacks

5% Protein; 50% Carbohydrates; 45% Fat

No snack was received (0 kJ)
Overall Number of Participants Analyzed 31 31 31
Mean (Standard Error)
Unit of Measure: Units on a Scale
Working Memory (pre-snack) 102  (3) 106  (2) 105  (2)
Reasoning (pre-snack) 107  (2) 108  (2) 105  (2)
Executive Function (pre-snack) 108  (3) 114  (2) 112  (2)
Reaction Time (pre-snack) 106  (3) 107  (3) 103  (2)
Sustained Attention (pre-snack) 102  (2) 105  (1) 106  (1)
Cognitive Flexibility (pre-snack) 108  (4) 114  (2) 110  (2)
Processing Speed (pre-snack) 110  (3) 114  (3) 112  (3)
Working Memory (post-snack) 106  (2) 106  (2) 104  (2)
Reasoning (post-snack) 106  (2) 110  (2) 109  (2)
Executive function (post-snack) 113  (2) 116  (2) 112  (2)
Reaction Time (post-snack) 103  (3) 107  (3) 105  (3)
Sustained Attention (post-snack) 106  (1) 105  (1) 104  (2)
Cognitive Flexibility (post-snack) 112  (3) 116  (2) 112  (2)
Processing Speed (post-snack) 118  (3) 122  (4) 119  (3)
5.Secondary Outcome
Title Mood-state Questionnaires
Hide Description 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.
Time Frame -30 min, +60 min
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Protein High Fat (Low Protein) No Snack
Hide Arm/Group Description:

Higher Protein Soy-based Snacks

High Protein: 250 kcal; 40% Protein; 40% Carbohydrate; 20% Fat

Typical High Fat (Low Protein) Snacks

5% Protein; 50% Carbohydrates; 45% Fat

No snack was received (0 kJ)
Overall Number of Participants Analyzed 31 31 31
Mean (Standard Error)
Unit of Measure: T-Score
Confusion (-30 min) 43.5  (0.7) 42.1  (0.4) 42.3  (0.6)
Confusion (+60 min) 42.2  (0.5) 41.8  (0.4) 42.4  (0.5)
Fatigue (-30 min) 47.4  (1.4) 48.2  (1.3) 49.6  (1.4)
Fatigue (+60 min) 47.9  (1.3) 47.2  (1.2) 50  (1.2)
Tension (-30 min 42.8  (0.5) 42.4  (0.4) 43.2  (0.7)
Tension (+60 min) 42.2  (0.4) 42.1  (0.4) 41.9  (0.3)
Vigor (-30 min) 45.6  (1.8) 44.2  (1.8) 45.0  (1.2)
Vigor (+60 min) 44.2  (1.9) 43.2  (1.6) 42.3  (1.5)
Anger (-30 min) 41.7  (0.5) 41.3  (0.4) 41.5  (0.5)
Anger (+60 min) 40.8  (0.3) 40.5  (0.2) 41.5  (0.6)
Depression (-30 min) 43.5  (0.6) 42.8  (0.5) 43.1  (0.6)
Depression (+60 min) 55.1  (12.5) 42.5  (0.2) 43  (0.5)
Friendliness (-30 min) 45.8  (1.6) 45.3  (1.6) 46.8  (1.4)
Friendliness (+60 min) 44.4  (1.6) 44.0  (1.7) 43.3  (1.5)
6.Secondary Outcome
Title Energy Intake
Hide Description

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.

Time Frame +300 min, 24 h
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Protein High Fat (Low Protein) No Snack
Hide Arm/Group Description:

Higher Protein Soy-based Snacks

High Protein: 250 kcal; 40% Protein; 40% Carbohydrate; 20% Fat

Typical High Fat (Low Protein) Snacks

5% Protein; 50% Carbohydrates; 45% Fat

No snack was received
Overall Number of Participants Analyzed 31 31 31
Mean (Standard Error)
Unit of Measure: kilojoules
3080  (230) 3370  (290) 3170  (240)
Time Frame 4 months (May 2013 through August 2013).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title High Protein Low Protein No Snack
Hide Arm/Group Description

Higher Protein Soy-based Snacks

High Protein: 250 kcal; 40% Protein; 40% Carbohydrate; 20% Fat

Typical, Low Protein Snacks

Low Protein: 5% Protein; 50% Carbohydrates; 45% Fat

No snack was received (0 kJ)
All-Cause Mortality
High Protein Low Protein No Snack
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
High Protein Low Protein No Snack
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)   0/31 (0.00%)   0/31 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
High Protein Low Protein No Snack
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)   0/31 (0.00%)   0/31 (0.00%) 
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Heather Leidy
Organization: University of Missouri
Phone: (573) 882-4288
EMail: leidyh@health.missouri.edu
Layout table for additonal information
Responsible Party: Heather Leidy, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT01781286    
Other Study ID Numbers: 00039414
First Submitted: January 9, 2013
First Posted: January 31, 2013
Results First Submitted: May 2, 2017
Results First Posted: July 23, 2018
Last Update Posted: July 23, 2018