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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

Tracking Information
First Submitted Date  ICMJE August 2, 2013
First Posted Date  ICMJE August 9, 2013
Results First Submitted Date  ICMJE November 13, 2017
Results First Posted Date  ICMJE August 28, 2019
Last Update Posted Date August 28, 2019
Study Start Date  ICMJE July 2013
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2019)
Difference in Pizza Consumed During Two Meals [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 6, 2013)
How much Pizza consumed during a meal [ Time Frame: 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2019)
  • Evaluation of Appetite [ Time Frame: 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.
  • Evaluation of Satiety by Means of Visual Analogue Scale [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2013)
  • Evaluation of Appetite [ Time Frame: 5 hours after lunch (9 hours after administration of Appethyl from the morning) ]
    The Visual Analogue scale allows you to mark a vertical line across the horizontal scale on how hungry you are or not. Then the evaluation of food preferences list of different nutrients-food items. The list of two carbohydrate foods like bread and pretzels and be asked to choose which would prefer most. The other choice will give the subject a list of food items that differ in the amounts of fat, protein and carbohydrate they contain. The subjects will be asked to mark the foods that appeal to them.
  • Evaluation of Satiety by Means of Visual Analogue Scale [ Time Frame: 5 hours after lunch (9 hours after administration of Appethyl from the morning) ]
    The Visual Analogue scale allows you to mark a vertical line across the horizontal scale on how hungry you are or not. Then the evaluation of food preferences list of different nutrients-food items. The list of two carbohydrate foods like bread and pretzels and be asked to choose which would prefer most. The other choice will give the subject a list of food items that differ in the amounts of fat, protein and carbohydrate they contain. The subjects will be asked to mark the foods that appeal to them.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Short-Term Appetite Suppression Trial Using Appethyl™: The Pizza
Official Title  ICMJE A Short-Term Appetite Suppression Trial Using Appethyl™: The Pizza
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Condition  ICMJE
  • Overweight
  • Obesity
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Dietary Supplement: Appethyl™
    • Other: Placebo
  • 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.
    Interventions:
    • Dietary Supplement: Appethyl™
    • Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 6, 2013)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01919814
Other Study ID Numbers  ICMJE PBRC 13022
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Frank Greenway, Pennington Biomedical Research Center
Study Sponsor  ICMJE Pennington Biomedical Research Center
Collaborators  ICMJE Greenleaf Medical
Investigators  ICMJE
Principal Investigator: Frank Greenway, MD Pennington Biomedical Research Center
PRS Account Pennington Biomedical Research Center
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP