Obesity, Overweight
Conditions
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.
Interventions
DIETARY_SUPPLEMENTAppethyl™
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.
OTHERPlacebo
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.
Sponsors
Greenleaf Medical
Pennington Biomedical Research Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Pizza Consumed During Two Meals | 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
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Appetite | 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. |
| Evaluation of Satiety by Means of Visual Analogue Scale | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 59 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 35.3 years STANDARD_DEVIATION 12.4 |
| Region of Enrollment United States | 59 Participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 60 | 0 / 60 |
| serious Total, serious adverse events | 1 / 60 | 1 / 60 |
Outcome results
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.
Time frame: 5 hours after lunch (9 hours after administration of Appethyl from the morning)
Population: One participant dropped because of adverse event
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Appethyl™ | Difference in Pizza Consumed During Two Meals | 1020.21 calories | Standard Deviation 554.35 |
| Placebo | Difference in Pizza Consumed During Two Meals | 1067.46 calories | Standard Deviation 551.63 |
p-value: >0.05t-test, 2 sided
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.
Time frame: 30 minutes, 60 minutes, 120 minutes after consuming the drug or placebo
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Appethyl™ | Evaluation of Appetite | Hunger - 60 minutes | 20.42 units on a scale | Standard Deviation 20.53 |
| Appethyl™ | Evaluation of Appetite | Satisfaction - 60 minutes | 72.41 units on a scale | Standard Deviation 23.28 |
| Appethyl™ | Evaluation of Appetite | Prospective Intake - 60 minutes | 21.33 units on a scale | Standard Deviation 22.42 |
| Appethyl™ | Evaluation of Appetite | Satisfaction - 120 minutes | 57.94 units on a scale | Standard Deviation 23.28 |
| Appethyl™ | Evaluation of Appetite | Hunger - 120 minutes | 30.16 units on a scale | Standard Deviation 20.53 |
| Appethyl™ | Evaluation of Appetite | Longing for Food - 60 minutes | 17.40 units on a scale | Standard Deviation 20.21 |
| Appethyl™ | Evaluation of Appetite | Fullness - 30 minutes | 85.7 units on a scale | Standard Deviation 21.3 |
| Appethyl™ | Evaluation of Appetite | Prospective Intake - 120 minutes | 34.48 units on a scale | Standard Deviation 22.42 |
| Appethyl™ | Evaluation of Appetite | Fullness - 60 minutes | 80.00 units on a scale | Standard Deviation 21.3 |
| Appethyl™ | Evaluation of Appetite | Longing for Food - 30 minutes | 12.59 units on a scale | Standard Deviation 20.21 |
| Appethyl™ | Evaluation of Appetite | Fullness - 120 minutes | 63.74 units on a scale | Standard Deviation 21.3 |
| Appethyl™ | Evaluation of Appetite | Longing for Food - 120 minutes | 27.49 units on a scale | Standard Deviation 20.21 |
| Appethyl™ | Evaluation of Appetite | Satisfaction - 30 minutes | 82.67 units on a scale | Standard Deviation 23.28 |
| Appethyl™ | Evaluation of Appetite | Prospective Intake - 30 minutes | 18.11 units on a scale | Standard Deviation 22.42 |
| Appethyl™ | Evaluation of Appetite | Hunger - 30 minutes | 12.14 units on a scale | Standard Deviation 29.53 |
| Placebo | Evaluation of Appetite | Satisfaction - 120 minutes | 53.16 units on a scale | Standard Deviation 22.98 |
| Placebo | Evaluation of Appetite | Hunger - 30 minutes | 15.77 units on a scale | Standard Deviation 20.4 |
| Placebo | Evaluation of Appetite | Hunger - 60 minutes | 22.13 units on a scale | Standard Deviation 20.31 |
| Placebo | Evaluation of Appetite | Fullness - 120 minutes | 59.80 units on a scale | Standard Deviation 21.02 |
| Placebo | Evaluation of Appetite | Longing for Food - 30 minutes | 14.27 units on a scale | Standard Deviation 20.11 |
| Placebo | Evaluation of Appetite | Longing for Food - 60 minutes | 22.39 units on a scale | Standard Deviation 20.03 |
| Placebo | Evaluation of Appetite | Prospective Intake - 30 minutes | 19.19 units on a scale | Standard Deviation 22.33 |
| Placebo | Evaluation of Appetite | Prospective Intake - 60 minutes | 26.49 units on a scale | Standard Deviation 22.25 |
| Placebo | Evaluation of Appetite | Prospective Intake - 120 minutes | 39.70 units on a scale | Standard Deviation 22.25 |
| Placebo | Evaluation of Appetite | Satisfaction - 30 minutes | 81.76 units on a scale | Standard Deviation 23.11 |
| Placebo | Evaluation of Appetite | Satisfaction - 60 minutes | 70.65 units on a scale | Standard Deviation 22.98 |
| Placebo | Evaluation of Appetite | Hunger - 120 minutes | 37.03 units on a scale | Standard Deviation 20.31 |
| Placebo | Evaluation of Appetite | Fullness - 30 minutes | 85.29 units on a scale | Standard Deviation 21.15 |
| Placebo | Evaluation of Appetite | Fullness - 60 minutes | 73.51 units on a scale | Standard Deviation 21.02 |
| Placebo | Evaluation of Appetite | Longing for Food - 120 minutes | 34.29 units on a scale | Standard Deviation 20.03 |
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.
Time frame: 30 minutes, 60 minutes, 120 minutes after consuming the drug or placebo
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Appethyl™ | Evaluation of Satiety by Means of Visual Analogue Scale | Desire for Salty Food - 30 minutes | 26.28 units on a scale | Standard Deviation 28.2 |
| Appethyl™ | Evaluation of Satiety by Means of Visual Analogue Scale | Desire for Salty Food - 60 minutes | 28.53 units on a scale | Standard Deviation 28.2 |
| Appethyl™ | Evaluation of Satiety by Means of Visual Analogue Scale | Desire for Savory Food - 60 minutes | 34.16 units on a scale | Standard Deviation 30.75 |
| Appethyl™ | Evaluation of Satiety by Means of Visual Analogue Scale | Desire for Savory Food - 120 minutes | 44.58 units on a scale | Standard Deviation 30.75 |
| Appethyl™ | Evaluation of Satiety by Means of Visual Analogue Scale | Thirst - 30 minutes | 27.76 units on a scale | Standard Deviation 26.38 |
| Appethyl™ | Evaluation of Satiety by Means of Visual Analogue Scale | Desire for Sweet Food - 30 minutes | 43.32 units on a scale | Standard Deviation 32.45 |
| Appethyl™ | Evaluation of Satiety by Means of Visual Analogue Scale | Desire for Salty Food - 120 minutes | 35.51 units on a scale | Standard Deviation 28.2 |
| Appethyl™ | Evaluation of Satiety by Means of Visual Analogue Scale | Desire for Savory Food - 30 minutes | 34.34 units on a scale | Standard Deviation 30.75 |
| Appethyl™ | Evaluation of Satiety by Means of Visual Analogue Scale | Thirst - 60 minutes | 37.63 units on a scale | Standard Deviation 26.38 |
| Appethyl™ | Evaluation of Satiety by Means of Visual Analogue Scale | Thirst - 120 minutes | 47.69 units on a scale | Standard Deviation 26.38 |
| Appethyl™ | Evaluation of Satiety by Means of Visual Analogue Scale | Desire for Sweet Food - 60 minutes | 47.50 units on a scale | Standard Deviation 32.45 |
| Appethyl™ | Evaluation of Satiety by Means of Visual Analogue Scale | Desire for Sweet Food - 120 minutes | 53.58 units on a scale | Standard Deviation 32.45 |
| Placebo | Evaluation of Satiety by Means of Visual Analogue Scale | Desire for Sweet Food - 120 minutes | 53.38 units on a scale | Standard Deviation 32.24 |
| Placebo | Evaluation of Satiety by Means of Visual Analogue Scale | Desire for Salty Food - 30 minutes | 30.53 units on a scale | Standard Deviation 28.16 |
| Placebo | Evaluation of Satiety by Means of Visual Analogue Scale | Thirst - 60 minutes | 43.01 units on a scale | Standard Deviation 26.21 |
| Placebo | Evaluation of Satiety by Means of Visual Analogue Scale | Desire for Salty Food - 60 minutes | 34.59 units on a scale | Standard Deviation 28.12 |
| Placebo | Evaluation of Satiety by Means of Visual Analogue Scale | Desire for Salty Food - 120 minutes | 40.62 units on a scale | Standard Deviation 28.12 |
| Placebo | Evaluation of Satiety by Means of Visual Analogue Scale | Desire for Sweet Food - 60 minutes | 48.77 units on a scale | Standard Deviation 32.24 |
| Placebo | Evaluation of Satiety by Means of Visual Analogue Scale | Desire for Savory Food - 60 minutes | 40.63 units on a scale | Standard Deviation 30.62 |
| Placebo | Evaluation of Satiety by Means of Visual Analogue Scale | Desire for Savory Food - 30 minutes | 38.83 units on a scale | Standard Deviation 30.68 |
| Placebo | Evaluation of Satiety by Means of Visual Analogue Scale | Desire for Savory Food - 120 minutes | 46.31 units on a scale | Standard Deviation 30.62 |
| Placebo | Evaluation of Satiety by Means of Visual Analogue Scale | Thirst - 30 minutes | 35.61 units on a scale | Standard Deviation 26.29 |
| Placebo | Evaluation of Satiety by Means of Visual Analogue Scale | Thirst - 120 minutes | 52.92 units on a scale | Standard Deviation 26.21 |
| Placebo | Evaluation of Satiety by Means of Visual Analogue Scale | Desire for Sweet Food - 30 minutes | 47.75 units on a scale | Standard Deviation 32.34 |