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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

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : July 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01919814


Locations
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United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
Greenleaf Medical
Investigators
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Principal Investigator: Frank Greenway, MD Pennington Biomedical Research Center
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Responsible Party: Frank Greenway, Clinical Medical Doctor, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01919814    
Other Study ID Numbers: PBRC 13022
First Posted: August 9, 2013    Key Record Dates
Results First Posted: August 28, 2019
Last Update Posted: August 28, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Overweight
Body Weight