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A Short-Term Appetite Suppression Trial Using Appethyl™: The Pizza (Pizza)

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ClinicalTrials.gov Identifier: NCT01919814
Recruitment Status : Completed
First Posted : August 9, 2013
Results First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Collaborator:
Greenleaf Medical
Information provided by (Responsible Party):
Frank Greenway, Pennington Biomedical Research Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Other
Conditions Overweight
Obesity
Interventions Dietary Supplement: Appethyl™
Other: Placebo
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Appethyl™ First, Then Placebo Placebo First, Then Appethyl™
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 30 30
Completed 27 30
Not Completed 3 0
Reason Not Completed
Adverse Event             1             0
Protocol Violation             1             0
Withdrawal by Subject             1             0
Arm/Group Title All Participants
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 59
Hide Baseline Analysis Population Description
One participant was dropped because of adverse event
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 59 participants
35.3  (12.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants
Female
29
  49.2%
Male
30
  50.8%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 59 participants
59
 100.0%
1.Primary Outcome
Title Difference in Pizza Consumed During Two Meals
Hide Description 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.
Time Frame 5 hours after lunch (9 hours after administration of Appethyl from the morning)
Hide Outcome Measure Data
Hide Analysis Population Description
One participant dropped because of adverse event
Arm/Group Title Appethyl™ Placebo
Hide Arm/Group Description:

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.

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.
Overall Number of Participants Analyzed 59 59
Mean (Standard Deviation)
Unit of Measure: calories
1020.21  (554.35) 1067.46  (551.63)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Appethyl™, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments Threshold P-Value was 0.05
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Evaluation of Appetite
Hide Description The 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.
Time Frame 30 minutes, 60 minutes, 120 minutes after consuming the drug or placebo
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Appethyl™ Placebo
Hide Arm/Group Description:

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.

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.
Overall Number of Participants Analyzed 59 59
Mean (Standard Deviation)
Unit of Measure: units on a scale
Hunger - 30 minutes 12.14  (29.53) 15.77  (20.40)
Hunger - 60 minutes 20.42  (20.53) 22.13  (20.31)
Hunger - 120 minutes 30.16  (20.53) 37.03  (20.31)
Fullness - 30 minutes 85.7  (21.30) 85.29  (21.15)
Fullness - 60 minutes 80.00  (21.30) 73.51  (21.02)
Fullness - 120 minutes 63.74  (21.30) 59.80  (21.02)
Longing for Food - 30 minutes 12.59  (20.21) 14.27  (20.11)
Longing for Food - 60 minutes 17.40  (20.21) 22.39  (20.03)
Longing for Food - 120 minutes 27.49  (20.21) 34.29  (20.03)
Prospective Intake - 30 minutes 18.11  (22.42) 19.19  (22.33)
Prospective Intake - 60 minutes 21.33  (22.42) 26.49  (22.25)
Prospective Intake - 120 minutes 34.48  (22.42) 39.70  (22.25)
Satisfaction - 30 minutes 82.67  (23.28) 81.76  (23.11)
Satisfaction - 60 minutes 72.41  (23.28) 70.65  (22.98)
Satisfaction - 120 minutes 57.94  (23.28) 53.16  (22.98)
3.Secondary Outcome
Title Evaluation of Satiety by Means of Visual Analogue Scale
Hide Description The 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.
Time Frame 30 minutes, 60 minutes, 120 minutes after consuming the drug or placebo
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Appethyl™ Placebo
Hide Arm/Group Description:

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.

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.
Overall Number of Participants Analyzed 59 59
Mean (Standard Deviation)
Unit of Measure: units on a scale
Desire for Salty Food - 30 minutes 26.28  (28.20) 30.53  (28.16)
Desire for Salty Food - 60 minutes 28.53  (28.20) 34.59  (28.12)
Desire for Salty Food - 120 minutes 35.51  (28.20) 40.62  (28.12)
Desire for Savory Food - 30 minutes 34.34  (30.75) 38.83  (30.68)
Desire for Savory Food - 60 minutes 34.16  (30.75) 40.63  (30.62)
Desire for Savory Food - 120 minutes 44.58  (30.75) 46.31  (30.62)
Thirst - 30 minutes 27.76  (26.38) 35.61  (26.29)
Thirst - 60 minutes 37.63  (26.38) 43.01  (26.21)
Thirst - 120 minutes 47.69  (26.38) 52.92  (26.21)
Desire for Sweet Food - 30 minutes 43.32  (32.45) 47.75  (32.34)
Desire for Sweet Food - 60 minutes 47.50  (32.45) 48.77  (32.24)
Desire for Sweet Food - 120 minutes 53.58  (32.45) 53.38  (32.24)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Appethyl™ Placebo
Hide Arm/Group Description

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.

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.
All-Cause Mortality
Appethyl™ Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Appethyl™ Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/60 (1.67%)      1/60 (1.67%)    
Nervous system disorders     
Severe Headache   1/60 (1.67%)  1 1/60 (1.67%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Appethyl™ Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/60 (0.00%)      0/60 (0.00%)    
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: Frank Greenway, MD
Organization: Pennington Biomedical Research Center
Phone: 2257632578
EMail: frank.greenway@pbrc.edu
Layout table for additonal information
Responsible Party: Frank Greenway, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01919814    
Other Study ID Numbers: PBRC 13022
First Submitted: August 2, 2013
First Posted: August 9, 2013
Results First Submitted: November 13, 2017
Results First Posted: August 28, 2019
Last Update Posted: August 28, 2019