Trial Outcomes & Findings for A Short-Term Appetite Suppression Trial Using Appethyl™: The Pizza (NCT NCT01919814)
NCT ID: NCT01919814
Last Updated: 2019-08-28
Results Overview
Four hours after breakfast administration of Appethyl™ or placebo(inactive liquid) is given. You will be presented with a standard lunch and then (5 hours after lunch) pizza in a quantity of more than you could reasonably be expected to eat 5 hours after the start of your lunch meal and be asked to eat to your satisfaction over 30 minutes. You are not expected to eat all of the pizza.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
5 hours after lunch (9 hours after administration of Appethyl from the morning)
Results posted on
2019-08-28
Participant Flow
Participant milestones
| Measure |
Appethyl™ First, Then Placebo
Appethyl™ liquid once four hours after breakfast.
Appethyl™: • Four hours after breakfast participants will be given a small amount of liquid to drink that will contain Appethyl™. After one week washout period, participants were given placebo drink.
Participants will not know which they are getting and it will be decided randomly, like flipping a coin. Participants will be presented with a pizza in a quantity more than they could reasonably be expected to eat 5 hours after the start of their lunch meal and be asked to eat to their satisfaction over 30 minutes. Participants are not expected to eat all of the pizza.
|
Placebo First, Then Appethyl™
Four hours after breakfast participants will be given a small amount of liquid to drink that will contain a placebo (inactive liquid). After a one week washout period, they were given Appethyl™.
Participants will not know which they are getting and it will be decided randomly, like flipping a coin. Participants will be presented with a pizza in a quantity more than they could reasonably be expected to eat 5 hours after the start of their lunch meal and be asked to eat to their satisfaction over 30 minutes. Participants are not expected to eat all of the pizza.
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|---|---|---|
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Overall Study
STARTED
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30
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30
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|
Overall Study
COMPLETED
|
27
|
30
|
|
Overall Study
NOT COMPLETED
|
3
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0
|
Reasons for withdrawal
| Measure |
Appethyl™ First, Then Placebo
Appethyl™ liquid once four hours after breakfast.
Appethyl™: • Four hours after breakfast participants will be given a small amount of liquid to drink that will contain Appethyl™. After one week washout period, participants were given placebo drink.
Participants will not know which they are getting and it will be decided randomly, like flipping a coin. Participants will be presented with a pizza in a quantity more than they could reasonably be expected to eat 5 hours after the start of their lunch meal and be asked to eat to their satisfaction over 30 minutes. Participants are not expected to eat all of the pizza.
|
Placebo First, Then Appethyl™
Four hours after breakfast participants will be given a small amount of liquid to drink that will contain a placebo (inactive liquid). After a one week washout period, they were given Appethyl™.
Participants will not know which they are getting and it will be decided randomly, like flipping a coin. Participants will be presented with a pizza in a quantity more than they could reasonably be expected to eat 5 hours after the start of their lunch meal and be asked to eat to their satisfaction over 30 minutes. Participants are not expected to eat all of the pizza.
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|---|---|---|
|
Overall Study
Adverse Event
|
1
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0
|
|
Overall Study
Protocol Violation
|
1
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0
|
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Overall Study
Withdrawal by Subject
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1
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0
|
Baseline Characteristics
A Short-Term Appetite Suppression Trial Using Appethyl™: The Pizza
Baseline characteristics by cohort
| Measure |
All Participants
n=59 Participants
Appethyl™ liquid or Placebo once four hours after breakfast.
Appethyl™: Four hours after breakfast participants will be given a small amount of liquid to drink that will contain Appethyl™ pr Placebo.
Participants will not know which they are getting and it will be decided randomly, like flipping a coin. Participants will be presented with a pizza in a quantity more than they could reasonably be expected to eat 5 hours after the start of their lunch meal and be asked to eat to their satisfaction over 30 minutes. Participants are not expected to eat all of the pizza.
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|---|---|
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Age, Continuous
|
35.3 years
STANDARD_DEVIATION 12.4 • n=93 Participants
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|
Sex: Female, Male
Female
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29 Participants
n=93 Participants
|
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Sex: Female, Male
Male
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30 Participants
n=93 Participants
|
|
Region of Enrollment
United States
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59 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 5 hours after lunch (9 hours after administration of Appethyl from the morning)Population: One participant dropped because of adverse event
Four hours after breakfast administration of Appethyl™ or placebo(inactive liquid) is given. You will be presented with a standard lunch and then (5 hours after lunch) pizza in a quantity of more than you could reasonably be expected to eat 5 hours after the start of your lunch meal and be asked to eat to your satisfaction over 30 minutes. You are not expected to eat all of the pizza.
Outcome measures
| Measure |
Appethyl™
n=59 Participants
Appethyl™ liquid once four hours after breakfast.
Appethyl™: Four hours after breakfast participants will be given a small amount of liquid to drink that will contain Appethyl™. Participants will not know which they are getting and it will be decided randomly, like flipping a coin. Participants will be presented with a pizza in a quantity more than they could reasonably be expected to eat 5 hours after the start of their lunch meal and be asked to eat to their satisfaction over 30 minutes. Participants are not expected to eat all of the pizza.
|
Placebo
n=59 Participants
Four hours after breakfast participants will be given a small amount of liquid to drink that will contain a placebo (inactive liquid). Participants will not know which they are getting and it will be decided randomly, like flipping a coin. Participants will be presented with a pizza in a quantity more than they could reasonably be expected to eat 5 hours after the start of their lunch meal and be asked to eat to their satisfaction over 30 minutes. Participants are not expected to eat all of the pizza.
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|---|---|---|
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Difference in Pizza Consumed During Two Meals
|
1020.21 calories
Standard Deviation 554.35
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1067.46 calories
Standard Deviation 551.63
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SECONDARY outcome
Timeframe: 30 minutes, 60 minutes, 120 minutes after consuming the drug or placeboThe Visual Analogue scale allows you to mark a vertical line across the horizontal scale on how hungry you are or not. The Visual Analogue scale was used to evaluate hunger, fullness, longing for food, prospective intake, satisfaction, desire for salty food, desire for savory food, thirst, and desire for sweet food. The scale ranged from 0 to 100mm; the higher values indicated greater outcomes.
Outcome measures
| Measure |
Appethyl™
n=59 Participants
Appethyl™ liquid once four hours after breakfast.
Appethyl™: Four hours after breakfast participants will be given a small amount of liquid to drink that will contain Appethyl™. Participants will not know which they are getting and it will be decided randomly, like flipping a coin. Participants will be presented with a pizza in a quantity more than they could reasonably be expected to eat 5 hours after the start of their lunch meal and be asked to eat to their satisfaction over 30 minutes. Participants are not expected to eat all of the pizza.
|
Placebo
n=59 Participants
Four hours after breakfast participants will be given a small amount of liquid to drink that will contain a placebo (inactive liquid). Participants will not know which they are getting and it will be decided randomly, like flipping a coin. Participants will be presented with a pizza in a quantity more than they could reasonably be expected to eat 5 hours after the start of their lunch meal and be asked to eat to their satisfaction over 30 minutes. Participants are not expected to eat all of the pizza.
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|---|---|---|
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Evaluation of Appetite
Fullness - 30 minutes
|
85.7 units on a scale
Standard Deviation 21.30
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85.29 units on a scale
Standard Deviation 21.15
|
|
Evaluation of Appetite
Fullness - 60 minutes
|
80.00 units on a scale
Standard Deviation 21.30
|
73.51 units on a scale
Standard Deviation 21.02
|
|
Evaluation of Appetite
Prospective Intake - 30 minutes
|
18.11 units on a scale
Standard Deviation 22.42
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19.19 units on a scale
Standard Deviation 22.33
|
|
Evaluation of Appetite
Prospective Intake - 60 minutes
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21.33 units on a scale
Standard Deviation 22.42
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26.49 units on a scale
Standard Deviation 22.25
|
|
Evaluation of Appetite
Hunger - 30 minutes
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12.14 units on a scale
Standard Deviation 29.53
|
15.77 units on a scale
Standard Deviation 20.40
|
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Evaluation of Appetite
Hunger - 60 minutes
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20.42 units on a scale
Standard Deviation 20.53
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22.13 units on a scale
Standard Deviation 20.31
|
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Evaluation of Appetite
Hunger - 120 minutes
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30.16 units on a scale
Standard Deviation 20.53
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37.03 units on a scale
Standard Deviation 20.31
|
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Evaluation of Appetite
Fullness - 120 minutes
|
63.74 units on a scale
Standard Deviation 21.30
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59.80 units on a scale
Standard Deviation 21.02
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Evaluation of Appetite
Longing for Food - 30 minutes
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12.59 units on a scale
Standard Deviation 20.21
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14.27 units on a scale
Standard Deviation 20.11
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Evaluation of Appetite
Longing for Food - 60 minutes
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17.40 units on a scale
Standard Deviation 20.21
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22.39 units on a scale
Standard Deviation 20.03
|
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Evaluation of Appetite
Longing for Food - 120 minutes
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27.49 units on a scale
Standard Deviation 20.21
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34.29 units on a scale
Standard Deviation 20.03
|
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Evaluation of Appetite
Prospective Intake - 120 minutes
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34.48 units on a scale
Standard Deviation 22.42
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39.70 units on a scale
Standard Deviation 22.25
|
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Evaluation of Appetite
Satisfaction - 30 minutes
|
82.67 units on a scale
Standard Deviation 23.28
|
81.76 units on a scale
Standard Deviation 23.11
|
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Evaluation of Appetite
Satisfaction - 60 minutes
|
72.41 units on a scale
Standard Deviation 23.28
|
70.65 units on a scale
Standard Deviation 22.98
|
|
Evaluation of Appetite
Satisfaction - 120 minutes
|
57.94 units on a scale
Standard Deviation 23.28
|
53.16 units on a scale
Standard Deviation 22.98
|
SECONDARY outcome
Timeframe: 30 minutes, 60 minutes, 120 minutes after consuming the drug or placeboThe Visual Analogue scale allows you to mark a vertical line across the horizontal scale on how hungry you are or not. The Visual Analogue scale was used to evaluate hunger, fullness, longing for food, prospective intake, satisfaction, desire for salty food, desire for savory food, thirst, and desire for sweet food. The scale ranged from 0 to 100mm; the higher values indicated greater outcomes.
Outcome measures
| Measure |
Appethyl™
n=59 Participants
Appethyl™ liquid once four hours after breakfast.
Appethyl™: Four hours after breakfast participants will be given a small amount of liquid to drink that will contain Appethyl™. Participants will not know which they are getting and it will be decided randomly, like flipping a coin. Participants will be presented with a pizza in a quantity more than they could reasonably be expected to eat 5 hours after the start of their lunch meal and be asked to eat to their satisfaction over 30 minutes. Participants are not expected to eat all of the pizza.
|
Placebo
n=59 Participants
Four hours after breakfast participants will be given a small amount of liquid to drink that will contain a placebo (inactive liquid). Participants will not know which they are getting and it will be decided randomly, like flipping a coin. Participants will be presented with a pizza in a quantity more than they could reasonably be expected to eat 5 hours after the start of their lunch meal and be asked to eat to their satisfaction over 30 minutes. Participants are not expected to eat all of the pizza.
|
|---|---|---|
|
Evaluation of Satiety by Means of Visual Analogue Scale
Desire for Salty Food - 60 minutes
|
28.53 units on a scale
Standard Deviation 28.20
|
34.59 units on a scale
Standard Deviation 28.12
|
|
Evaluation of Satiety by Means of Visual Analogue Scale
Desire for Salty Food - 120 minutes
|
35.51 units on a scale
Standard Deviation 28.20
|
40.62 units on a scale
Standard Deviation 28.12
|
|
Evaluation of Satiety by Means of Visual Analogue Scale
Desire for Savory Food - 60 minutes
|
34.16 units on a scale
Standard Deviation 30.75
|
40.63 units on a scale
Standard Deviation 30.62
|
|
Evaluation of Satiety by Means of Visual Analogue Scale
Desire for Savory Food - 120 minutes
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44.58 units on a scale
Standard Deviation 30.75
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46.31 units on a scale
Standard Deviation 30.62
|
|
Evaluation of Satiety by Means of Visual Analogue Scale
Thirst - 120 minutes
|
47.69 units on a scale
Standard Deviation 26.38
|
52.92 units on a scale
Standard Deviation 26.21
|
|
Evaluation of Satiety by Means of Visual Analogue Scale
Desire for Sweet Food - 30 minutes
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43.32 units on a scale
Standard Deviation 32.45
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47.75 units on a scale
Standard Deviation 32.34
|
|
Evaluation of Satiety by Means of Visual Analogue Scale
Desire for Sweet Food - 120 minutes
|
53.58 units on a scale
Standard Deviation 32.45
|
53.38 units on a scale
Standard Deviation 32.24
|
|
Evaluation of Satiety by Means of Visual Analogue Scale
Desire for Salty Food - 30 minutes
|
26.28 units on a scale
Standard Deviation 28.20
|
30.53 units on a scale
Standard Deviation 28.16
|
|
Evaluation of Satiety by Means of Visual Analogue Scale
Desire for Savory Food - 30 minutes
|
34.34 units on a scale
Standard Deviation 30.75
|
38.83 units on a scale
Standard Deviation 30.68
|
|
Evaluation of Satiety by Means of Visual Analogue Scale
Thirst - 30 minutes
|
27.76 units on a scale
Standard Deviation 26.38
|
35.61 units on a scale
Standard Deviation 26.29
|
|
Evaluation of Satiety by Means of Visual Analogue Scale
Thirst - 60 minutes
|
37.63 units on a scale
Standard Deviation 26.38
|
43.01 units on a scale
Standard Deviation 26.21
|
|
Evaluation of Satiety by Means of Visual Analogue Scale
Desire for Sweet Food - 60 minutes
|
47.50 units on a scale
Standard Deviation 32.45
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48.77 units on a scale
Standard Deviation 32.24
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Adverse Events
Appethyl™
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Appethyl™
n=60 participants at risk
Appethyl™ liquid once four hours after breakfast.
Appethyl™: Four hours after breakfast participants will be given a small amount of liquid to drink that will contain Appethyl™. Participants will not know which they are getting and it will be decided randomly, like flipping a coin. Participants will be presented with a pizza in a quantity more than they could reasonably be expected to eat 5 hours after the start of their lunch meal and be asked to eat to their satisfaction over 30 minutes. Participants are not expected to eat all of the pizza.
|
Placebo
n=60 participants at risk
Four hours after breakfast participants will be given a small amount of liquid to drink that will contain a placebo (inactive liquid). Participants will not know which they are getting and it will be decided randomly, like flipping a coin. Participants will be presented with a pizza in a quantity more than they could reasonably be expected to eat 5 hours after the start of their lunch meal and be asked to eat to their satisfaction over 30 minutes. Participants are not expected to eat all of the pizza.
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|---|---|---|
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Nervous system disorders
Severe Headache
|
1.7%
1/60 • Number of events 1
|
1.7%
1/60 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place