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

• Sponsor: Pennington Biomedical Research Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01919814
• Collaborator: Greenleaf Medical (Other)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 29
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

The purpose of the study is to determine whether Appethyl™, made from spinach, will reduce appetite and hunger given on the same day of testing.

Condition or Disease	Intervention/Treatment	Phase
Overweight; Obesity	Dietary Supplement: Appethyl™; Other: Placebo	N/A

Detailed Description

Four hours after breakfast a small amount of liquid to drink will be given to a participant that will contain either the Appethyl™ or placebo. Participants will be given a lunch of about 750 calories and 40% fat prepared by the Metabolic Kitchen and be asked to eat all of it. Participants will have food choice testing performed 4 hours after starting their lunch meal. This will be done in two ways. Participants will be given a list of two foods that are made of carbohydrate like bread and pretzels and be asked which is most preferred. Participants will also be given a list of foods that differ in the amounts of fat, carbohydrate and protein that they contain and will be asked to mark the ones that appeal to them.

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Other
• Official Title: A Short-Term Appetite Suppression Trial Using Appethyl™: The Pizza
• Study Start Date: Jul 1, 2013
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Appethyl™, then Placebo Participants receive Appethyl™ liquid once four hours after breakfast. After a washout period of at least one week, they received the placebo drink once four hours after breakfast.	Dietary Supplement: Appethyl™; Four hours after breakfast participants will be given a small amount of liquid to drink that will contain Appethyl™. They 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.; Other: Placebo; 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. They are not expected to eat all of the pizza.
Placebo Comparator: Placebo, then Appethyl™ Participants receive the placebo drink once four hours after breakfast. After a washout period of at least one week, they received Appethyl™ liquid once four hours after breakfast.	Dietary Supplement: Appethyl™; Four hours after breakfast participants will be given a small amount of liquid to drink that will contain Appethyl™. They 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.; Other: Placebo; 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. They are not expected to eat all of the pizza.

Outcome Measures

Primary Outcome Measures

1. Difference in Pizza Consumed During Two Meals [5 hours after lunch (9 hours after administration of Appethyl from the morning)]

   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.

Secondary Outcome Measures

1. Evaluation of Appetite [30 minutes, 60 minutes, 120 minutes after consuming the drug or placebo]

   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.

2. Evaluation of Satiety by Means of Visual Analogue Scale [30 minutes, 60 minutes, 120 minutes after consuming the drug or placebo]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• You are a male or female aged 18 to 65 years.

• You have a BMI (a number calculated from your height and weight) between 25-35 kg/m2, inclusive.

• Your waist circumference is over 35 inches.

Exclusion Criteria:

• You have been on a diet for weight loss in the last 2 months.

• You are being treated for blood pressure, diabetes, heart disease, rheumatoid arthritis, or blood vessel disease.

• You have a psychotic illness.

• You have other chronic diseases like an inflammatory bowel disease such as Crohn's disease or ulcerative colitis.

• You have a dysfunction of your gastrointestinal tract.

• You have food allergies.

• You have rheumatoid arthritis with inflammation.

• You have chronic constipation.

• You are taking any products to lose weight such as medication for obesity or non-prescription medications for weight loss.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pennington Biomedical Research Center	Baton Rouge	Louisiana	United States	70808

Sponsors and Collaborators

• Pennington Biomedical Research Center
• Greenleaf Medical

Investigators

• Principal Investigator: Frank Greenway, MD, Pennington Biomedical Research Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Frank Greenway, Clinical Medical Doctor, Pennington Biomedical Research Center
• ClinicalTrials.gov Identifier: NCT01919814
• Other Study ID Numbers: PBRC 13022
• First Posted: Aug 9, 2013
• Last Update Posted: Aug 28, 2019
• Last Verified: Aug 1, 2019

• Additional relevant MeSH terms: Overweight

Study Results

Participant Flow

Arm/Group Title	Appethyl™ First, Then Placebo	Placebo First, Then Appethyl™
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

Baseline Characteristics

Arm/Group Title	All Participants
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 Participants	59
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35.3 (12.4)
Sex: Female, Male (Count of Participants)
Female	29 49.2%
Male	30 50.8%
Region of Enrollment (Count of Participants)
United States	59 100%

Outcome Measures

1. Primary Outcome

Title	Difference in Pizza Consumed During Two Meals
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)

Outcome Measure Data

Analysis Population Description

One participant dropped because of adverse event

Arm/Group Title	Appethyl™	Placebo
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.
Measure Participants	59	59
Mean (Standard Deviation) [calories]	1020.21 (554.35)	1067.46 (551.63)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Appethyl™, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	Threshold P-Value was 0.05
	Method	t-test, 2 sided
	Comments

2. Secondary Outcome

Title	Evaluation of Appetite
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Appethyl™	Placebo
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.
Measure Participants	59	59
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Appethyl™	Placebo
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.
Measure Participants	59	59
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)

Adverse Events

Arm/Group Title	Appethyl™		Placebo
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Appethyl™		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/60 (1.7%)		1/60 (1.7%)
Nervous system disorders
Severe Headache	1/60 (1.7%)	1	1/60 (1.7%)	1
Other (Not Including Serious) Adverse Events
	Appethyl™		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/60 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.