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

Pennington Biomedical Research Center

Status: Completed

Conditions: Overweight; Obesity

Treatments: Dietary Supplement: Appethyl™; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01919814

PBRC 13022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Appethyl™, then Placebo

Active Comparator group

Description:

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.

Treatment:

Other: Placebo

Dietary Supplement: Appethyl™

Placebo, then Appethyl™

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo

Dietary Supplement: Appethyl™