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

Obesity Clinical Trial

— Pizza  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01919814
• Other study ID #: PBRC 13022
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Est. completion date: December 2015

Study information

• Verified date: August 2019
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

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.

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	Greenleaf Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 hours after lunch (9 hours after administration of Appethyl from the morning)
Secondary	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.	30 minutes, 60 minutes, 120 minutes after consuming the drug or placebo
Secondary	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.	30 minutes, 60 minutes, 120 minutes after consuming the drug or placebo