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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Overweight, Obesity

Intervention / Treatment
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* Dietary Supplement: Appethyl™
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Appethyl™, then Placebo<br>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™<br>* 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.<br>Other: Placebo<br>* 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.<br>|
| Placebo Comparator: Placebo, then Appethyl™<br>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™<br>* 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.<br>Other: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |