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

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Appethyl™
Placebo
Sponsored by
Pennington Biomedical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Overweight

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Pennington Biomedical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Appethyl™, then Placebo

Placebo, then Appethyl™

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Difference in Pizza Consumed During Two Meals
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

Evaluation of Appetite
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.
Evaluation of Satiety by Means of Visual Analogue Scale
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.

Full Information

First Posted
August 2, 2013
Last Updated
August 17, 2019
Sponsor
Pennington Biomedical Research Center
Collaborators
Greenleaf Medical
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1. Study Identification

Unique Protocol Identification Number
NCT01919814
Brief Title
A Short-Term Appetite Suppression Trial Using Appethyl™: The Pizza
Acronym
Pizza
Official Title
A Short-Term Appetite Suppression Trial Using Appethyl™: The Pizza
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pennington Biomedical Research Center
Collaborators
Greenleaf Medical

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Appethyl™, then Placebo
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo, then Appethyl™
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Appethyl™
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
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)
Secondary Outcome Measure Information:
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Greenway, MD
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States

12. IPD Sharing Statement

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

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