Trial Outcomes & Findings for The Beneficial Effects of Healthy Snacks on Appetite Control, Satiety, and Reward-driven Eating Behavior in Young People (NCT NCT01781286)

Last Updated: 2018-07-23

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

37 participants

Primary outcome timeframe

1 Day

Results posted on

2018-07-23

Participant Flow

Participant milestones

Participant milestones
Measure	High Fat Snack > No Snack > High Protein Snack 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.	High Fat Snack > High Protein Snack > No Snack 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.	No Snack > High Protein Snack > High Fat Snack 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.	No Snack > High Fat Snack > High Protein Snack 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.	High Protein Snack > No Snack > High Fat Snack 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.	High Protein Snack > High Fat Snack > No Snack 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.
Overall Study STARTED	7	4	9	8	6	3
Overall Study Started 1st Intervention	6	4	9	8	6	2
Overall Study Started 2nd Intervention	5	4	9	8	6	2
Overall Study Started 3rd Intervention	5	4	7	7	6	2
Overall Study COMPLETED	5	4	7	7	6	2
Overall Study NOT COMPLETED	2	0	2	1	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	High Fat Snack > No Snack > High Protein Snack 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.	No Snack > High Protein Snack > High Fat Snack 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.	No Snack > High Fat Snack > High Protein Snack 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.	High Protein Snack > High Fat Snack > No Snack 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.
Overall Study Lost to Follow-up	0	0	0	1
Overall Study Time Constraints	2	2	0	0
Overall Study Noncompliance	0	0	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=31 Participants 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.
Age, Continuous	17 years STANDARD_DEVIATION 1 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Region of Enrollment United States	31 Participants n=5 Participants
Height	171 centimeters STANDARD_DEVIATION 2 • n=5 Participants
Weight	65.6 kilograms STANDARD_DEVIATION 2.1 • n=5 Participants
BMI (kg/m2)	22.3 kg/m2 STANDARD_DEVIATION 0.4 • n=5 Participants
BMI (%)	58.4 Percentile STANDARD_DEVIATION 4.4 • n=5 Participants
Frequency of Snacking	6 days/week STANDARD_DEVIATION 1 • n=5 Participants
Commonly consumed chips/crackers as a snack	64 % of total participants n=5 Participants
Commonly consumed fruit as a snack	61 % of total participants n=5 Participants
Commonly consumed cereal as a snack	25 % of total participants n=5 Participants

PRIMARY outcome

Timeframe: 1 Day

Outcome measures

Outcome measures
Measure	High Protein n=31 Participants Higher Protein Soy-based Snacks High Protein: 250 kcal; 40% Protein; 40% Carbohydrate; 20% Fat	High Fat (Low Protein) n=31 Participants Typical High Fat (Low Protein) Snacks 5% Protein; 50% Carbohydrates; 45% Fat	No Snack n=31 Participants No snack was received
Time to Dinner Request	158 minutes Standard Error 7	150 minutes Standard Error 6	140 minutes Standard Error 6

SECONDARY outcome

Timeframe: 0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min, +270 min, +300 min

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.

Outcome measures

Outcome measures
Measure	High Protein n=31 Participants Higher Protein Soy-based Snacks High Protein: 250 kcal; 40% Protein; 40% Carbohydrate; 20% Fat	High Fat (Low Protein) n=31 Participants Typical High Fat (Low Protein) Snacks 5% Protein; 50% Carbohydrates; 45% Fat	No Snack n=31 Participants No snack was received
Appetite Questionnaires	-5500 mm*min Standard Error 1000	-3000 mm*min Standard Error 1000	3000 mm*min Standard Error 1000

SECONDARY outcome

Timeframe: 5 min

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.

Outcome measures

Outcome measures
Measure	High Protein n=31 Participants Higher Protein Soy-based Snacks High Protein: 250 kcal; 40% Protein; 40% Carbohydrate; 20% Fat	High Fat (Low Protein) n=31 Participants Typical High Fat (Low Protein) Snacks 5% Protein; 50% Carbohydrates; 45% Fat	No Snack n=31 Participants No snack was received
Snack Palatability and Perception Questionnaires	69 millimeters Standard Error 4	80 millimeters Standard Error 3	NA millimeters Standard Error NA No snack was consumed. Therefore, palatability could not be assessed.

SECONDARY outcome

Timeframe: 90 min

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.

Outcome measures

Outcome measures
Measure	High Protein n=31 Participants Higher Protein Soy-based Snacks High Protein: 250 kcal; 40% Protein; 40% Carbohydrate; 20% Fat	High Fat (Low Protein) n=31 Participants Typical High Fat (Low Protein) Snacks 5% Protein; 50% Carbohydrates; 45% Fat	No Snack n=31 Participants No snack was received
Attention & Memory Questionnaires Working Memory (pre-snack)	102 Units on a Scale Standard Error 3	106 Units on a Scale Standard Error 2	105 Units on a Scale Standard Error 2
Attention & Memory Questionnaires Reasoning (pre-snack)	107 Units on a Scale Standard Error 2	108 Units on a Scale Standard Error 2	105 Units on a Scale Standard Error 2
Attention & Memory Questionnaires Executive Function (pre-snack)	108 Units on a Scale Standard Error 3	114 Units on a Scale Standard Error 2	112 Units on a Scale Standard Error 2
Attention & Memory Questionnaires Reaction Time (pre-snack)	106 Units on a Scale Standard Error 3	107 Units on a Scale Standard Error 3	103 Units on a Scale Standard Error 2
Attention & Memory Questionnaires Sustained Attention (pre-snack)	102 Units on a Scale Standard Error 2	105 Units on a Scale Standard Error 1	106 Units on a Scale Standard Error 1
Attention & Memory Questionnaires Cognitive Flexibility (pre-snack)	108 Units on a Scale Standard Error 4	114 Units on a Scale Standard Error 2	110 Units on a Scale Standard Error 2
Attention & Memory Questionnaires Processing Speed (pre-snack)	110 Units on a Scale Standard Error 3	114 Units on a Scale Standard Error 3	112 Units on a Scale Standard Error 3
Attention & Memory Questionnaires Working Memory (post-snack)	106 Units on a Scale Standard Error 2	106 Units on a Scale Standard Error 2	104 Units on a Scale Standard Error 2
Attention & Memory Questionnaires Reasoning (post-snack)	106 Units on a Scale Standard Error 2	110 Units on a Scale Standard Error 2	109 Units on a Scale Standard Error 2
Attention & Memory Questionnaires Executive function (post-snack)	113 Units on a Scale Standard Error 2	116 Units on a Scale Standard Error 2	112 Units on a Scale Standard Error 2
Attention & Memory Questionnaires Reaction Time (post-snack)	103 Units on a Scale Standard Error 3	107 Units on a Scale Standard Error 3	105 Units on a Scale Standard Error 3
Attention & Memory Questionnaires Sustained Attention (post-snack)	106 Units on a Scale Standard Error 1	105 Units on a Scale Standard Error 1	104 Units on a Scale Standard Error 2
Attention & Memory Questionnaires Cognitive Flexibility (post-snack)	112 Units on a Scale Standard Error 3	116 Units on a Scale Standard Error 2	112 Units on a Scale Standard Error 2
Attention & Memory Questionnaires Processing Speed (post-snack)	118 Units on a Scale Standard Error 3	122 Units on a Scale Standard Error 4	119 Units on a Scale Standard Error 3

SECONDARY outcome

Timeframe: -30 min, +60 min

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.

Outcome measures

Outcome measures
Measure	High Protein n=31 Participants Higher Protein Soy-based Snacks High Protein: 250 kcal; 40% Protein; 40% Carbohydrate; 20% Fat	High Fat (Low Protein) n=31 Participants Typical High Fat (Low Protein) Snacks 5% Protein; 50% Carbohydrates; 45% Fat	No Snack n=31 Participants No snack was received
Mood-state Questionnaires Confusion (-30 min)	43.5 T-Score Standard Error 0.7	42.1 T-Score Standard Error 0.4	42.3 T-Score Standard Error 0.6
Mood-state Questionnaires Confusion (+60 min)	42.2 T-Score Standard Error 0.5	41.8 T-Score Standard Error 0.4	42.4 T-Score Standard Error 0.5
Mood-state Questionnaires Fatigue (-30 min)	47.4 T-Score Standard Error 1.4	48.2 T-Score Standard Error 1.3	49.6 T-Score Standard Error 1.4
Mood-state Questionnaires Fatigue (+60 min)	47.9 T-Score Standard Error 1.3	47.2 T-Score Standard Error 1.2	50 T-Score Standard Error 1.2
Mood-state Questionnaires Tension (-30 min	42.8 T-Score Standard Error 0.5	42.4 T-Score Standard Error 0.4	43.2 T-Score Standard Error 0.7
Mood-state Questionnaires Tension (+60 min)	42.2 T-Score Standard Error 0.4	42.1 T-Score Standard Error 0.4	41.9 T-Score Standard Error 0.3
Mood-state Questionnaires Vigor (-30 min)	45.6 T-Score Standard Error 1.8	44.2 T-Score Standard Error 1.8	45.0 T-Score Standard Error 1.2
Mood-state Questionnaires Vigor (+60 min)	44.2 T-Score Standard Error 1.9	43.2 T-Score Standard Error 1.6	42.3 T-Score Standard Error 1.5
Mood-state Questionnaires Anger (-30 min)	41.7 T-Score Standard Error 0.5	41.3 T-Score Standard Error 0.4	41.5 T-Score Standard Error 0.5
Mood-state Questionnaires Anger (+60 min)	40.8 T-Score Standard Error 0.3	40.5 T-Score Standard Error 0.2	41.5 T-Score Standard Error 0.6
Mood-state Questionnaires Depression (-30 min)	43.5 T-Score Standard Error 0.6	42.8 T-Score Standard Error 0.5	43.1 T-Score Standard Error 0.6
Mood-state Questionnaires Depression (+60 min)	55.1 T-Score Standard Error 12.5	42.5 T-Score Standard Error 0.2	43 T-Score Standard Error 0.5
Mood-state Questionnaires Friendliness (-30 min)	45.8 T-Score Standard Error 1.6	45.3 T-Score Standard Error 1.6	46.8 T-Score Standard Error 1.4
Mood-state Questionnaires Friendliness (+60 min)	44.4 T-Score Standard Error 1.6	44.0 T-Score Standard Error 1.7	43.3 T-Score Standard Error 1.5

SECONDARY outcome

Timeframe: +300 min, 24 h

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.

Outcome measures

Outcome measures
Measure	High Protein n=31 Participants Higher Protein Soy-based Snacks High Protein: 250 kcal; 40% Protein; 40% Carbohydrate; 20% Fat	High Fat (Low Protein) n=31 Participants Typical High Fat (Low Protein) Snacks 5% Protein; 50% Carbohydrates; 45% Fat	No Snack n=31 Participants No snack was received
Energy Intake	3080 kilojoules Standard Error 230	3370 kilojoules Standard Error 290	3170 kilojoules Standard Error 240

Adverse Events

High Protein

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Low Protein

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Snack

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Heather Leidy

University of Missouri

Phone: (573) 882-4288

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place