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Completed

NCT Number: NCT01919814

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

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.

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Difference in Pizza Consumed During Two Meals

    Time frame: 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 outcomes

  1. Evaluation of Appetite

    Time frame: 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.

  2. Evaluation of Satiety by Means of Visual Analogue Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Collaborators

  • Greenleaf Medical

Registry information

Acronym: Pizza

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Aug 9, 2013
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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