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| Name | Class |
|---|---|
| Greenleaf Medical | UNKNOWN |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Appethyl™, then Placebo | Active Comparator | 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. |
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| Placebo, then Appethyl™ | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Appethyl™ | Dietary Supplement | 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. |
| 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) |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank Greenway, MD | Pennington Biomedical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Appethyl™ First, Then Placebo | Appethyl™ liquid once four hours after breakfast. Appethyl™: • Four hours after breakfast participants will be given a small amount of liquid to drink that will contain Appethyl™. After one week washout period, participants were given placebo drink. 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. Participants are not expected to eat all of the pizza. |
| FG001 | Placebo First, Then Appethyl™ | Four hours after breakfast participants will be given a small amount of liquid to drink that will contain a placebo (inactive liquid). After a one week washout period, they were given Appethyl™. 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. Participants are not expected to eat all of the pizza. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
One participant was dropped because of adverse event
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Appethyl™ liquid or Placebo once four hours after breakfast. Appethyl™: Four hours after breakfast participants will be given a small amount of liquid to drink that will contain Appethyl™ pr Placebo. 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. Participants are not expected to eat all of the pizza. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | One participant dropped because of adverse event | Posted | Mean | Standard Deviation | calories | 5 hours after lunch (9 hours after administration of Appethyl from the morning) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Appethyl™ | Appethyl™ liquid once four hours after breakfast. Appethyl™: Four hours after breakfast participants will be given a small amount of liquid to drink that will contain Appethyl™. 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. Participants are not expected to eat all of the pizza. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Frank Greenway, MD | Pennington Biomedical Research Center | 2257632578 | frank.greenway@pbrc.edu |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Placebo | Other | 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. |
|
| 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 |
| Withdrawal by Subject |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | 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. Participants are not expected to eat all of the pizza. |
|
|
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| 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. | Posted | Mean | Standard Deviation | units on a scale | 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. | Posted | Mean | Standard Deviation | units on a scale | 30 minutes, 60 minutes, 120 minutes after consuming the drug or placebo |
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|
|
| 1 |
| 60 |
| 0 |
| 60 |
| EG001 | 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. Participants are not expected to eat all of the pizza. | 1 | 60 | 0 | 60 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Hunger - 120 minutes |
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| Fullness - 30 minutes |
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| Fullness - 60 minutes |
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| Fullness - 120 minutes |
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| Longing for Food - 30 minutes |
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| Longing for Food - 60 minutes |
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| Longing for Food - 120 minutes |
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| Prospective Intake - 30 minutes |
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| Prospective Intake - 60 minutes |
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| Prospective Intake - 120 minutes |
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| Satisfaction - 30 minutes |
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| Satisfaction - 60 minutes |
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| Satisfaction - 120 minutes |
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| Desire for Salty Food - 120 minutes |
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| Desire for Savory Food - 30 minutes |
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| Desire for Savory Food - 60 minutes |
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| Desire for Savory Food - 120 minutes |
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| Thirst - 30 minutes |
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| Thirst - 60 minutes |
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| Thirst - 120 minutes |
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| Desire for Sweet Food - 30 minutes |
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| Desire for Sweet Food - 60 minutes |
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| Desire for Sweet Food - 120 minutes |
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