OverweightPizzaNCT01919814
A Short-Term Appetite Suppression Trial Using Appethyl™: The Pizza
A study testing Appethyl™ in people with Overweight and Obesity, run by Pennington Biomedical Research Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Appethyl™
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
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.
Read the 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.
- Conditions
- Overweight, Obesity
- Being tested
- Appethyl™, Placebo
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Appethyl™; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 hours after lunch (9 hours after administration of Appethyl from the morning)
Secondary outcomes (2)
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.
Measured: 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.
Measured: 30 minutes, 60 minutes, 120 minutes after consuming the drug or placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Greenleaf Medical
- Responsible party
- Principal investigator, Frank Greenway, Pennington Biomedical Research Center
- Investigators
- Frank Greenway, MD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01919814
- Sponsor's protocol ID
- PBRC 13022
- Acronym
- Pizza
- Status last verified
- Aug 2019
- First submitted
- 2 Aug 2013
- Last updated
- 28 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Short-Term Appetite Suppression Trial Using Appethyl™: The Pizza
- ClinicalTrials.gov ID
- NCT01919814
- Acronym / sponsor ID
- Pizza / PBRC 13022
- Conditions
- Overweight, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- Greenleaf Medical
- Study start
- Jul 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 9 Aug 2013 (estimated)
- Results
- Posted 28 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Appethyl™, then Placebo | Active comparator | Dietary Supplement: Appethyl™, Other: PlaceboParticipants 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. |
| Placebo, then Appethyl™ | Placebo comparator | Dietary Supplement: Appethyl™, Other: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Appethyl™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. | Dietary supplement | Appethyl™, then Placebo, Placebo, then Appethyl™ |
| PlaceboFour 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. | Other | Appethyl™, then Placebo, Placebo, then Appethyl™ |
Primary outcome
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.
2 secondary outcomes
Evaluation of Appetite
Time frame: 30 minutes, 60 minutes, 120 minutes after consuming the drug or placebo
Evaluation of Satiety by Means of Visual Analogue Scale
Time frame: 30 minutes, 60 minutes, 120 minutes after consuming the drug or placebo
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Greenway, MD principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Appethyl™ in people with Overweight and Obesity, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Pizza Consumed During Two Meals (time frame: 5 hours after lunch (9 hours after administration of Appethyl from the morning)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019; AzTrials last refreshed its copy on 30 Oct 2026.