Clinical trial NCT01919814: A Short-Term Appetite Suppression Trial Using Appethyl™: The Pizza
Official title: A Short-Term Appetite Suppression Trial Using Appethyl™: The Pizza
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: Greenleaf Medical
First posted: 2013-08-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Difference in Pizza Consumed During Two Meals
timeFrame: 5 hours after lunch (9 hours after administration of Appethyl from the morning)
Secondary outcomes:
measure: Evaluation of Appetite
timeFrame: 30 minutes, 60 minutes, 120 minutes after consuming the drug or placebo
measure: Evaluation of Satiety by Means of Visual Analogue Scale
timeFrame: 30 minutes, 60 minutes, 120 minutes after consuming the drug or placebo
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Frank Greenway, MD
role: PRINCIPAL_INVESTIGATOR
References: