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

NCT01919814 | Completed Results

• 1 other identifier: PBRC 13022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Evaluation of Appetite

  30 minutes, 60 minutes, 120 minutes after consuming the drug or placebo

• Evaluation of Satiety by Means of Visual Analogue Scale

  30 minutes, 60 minutes, 120 minutes after consuming the drug or placebo

Study Arms (2)

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.

Dietary Supplement: Appethyl™; Other: Placebo

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.

Dietary Supplement: Appethyl™; Other: Placebo

Interventions

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.

Appethyl™, then Placebo; Placebo, then Appethyl™

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.

Appethyl™, then Placebo; Placebo, then Appethyl™

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• Greenleaf Medical: collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Frank Greenway, MD
• Organization: Pennington Biomedical Research Center

frank.greenway@pbrc.edu

2257632578

Study Officials

• Frank Greenway, MD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Medical Doctor

Study Record Dates

• First Submitted: August 2, 2013
• First Posted: August 9, 2013
• Study Start: July 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 28, 2019
• Results First Posted: August 28, 2019

Record last verified: 2019-08

Locations

US (1)