AppetiteNCT01530061
The Satiating Effect of Eggs in Children
A study testing Egg Breakfast and Bagel Breakfast in people with Appetite, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
This study will determine which breakfast (egg breakfast or bagel breakfast) has the most beneficial effect on appetite. Read more about this study
- Who is it for?
- Ages 4 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Appetite
- What is being tested?
- Egg Breakfast and Bagel Breakfast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 4 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- • Is a healthy boy or girl between 14 and 17 years of age
- Is a healthy boy or girl between 4 and 6 years of age
Who cannot join
- • Is suffering from any diseases such as major heart conditions, type 1 diabetes, cancer, eating disorders, or any serious illness that requires intensive and long-term medical treatment
- Has allergies/sensitivities/dislikes to eggs, soy, or wheat
- Uses drugs recreationally
- Is actively attempting to lose weight
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
This study will determine which breakfast (egg breakfast or bagel breakfast) has the most beneficial effect on appetite.
Read the detailed description
Test Day 1 (about 4 hours)
- This is a fasting visit (nothing besides water 12 hours prior to visit)
- Your child will be offered one of two breakfasts (egg breakfast or bagel breakfast) . He/she will be asked to eat all the food that is provided.
- He/she will be asked to rate the taste of the meal.
- He/she will be offered a pasta lunch.
Test Day 2 (about 4 hours)
- This will be scheduled 1 week after Test Day 1
- This is a fasting visit (nothing besides water 12 hours prior to visit)
- The procedures for this visit are the same as for Test Day 1. Your child will be offered the breakfast that he/she did not receive at the last visit.
The sequence of the 2 breakfasts will be randomly assigned to each child.
- Conditions
- Appetite
- Being tested
- Egg Breakfast, Bagel Breakfast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Egg BreakfastOther
Also called Egg
Egg, Toast and Jelly
Bagel BreakfastOther
Also called Bagel
Bagel, Cream Cheese and Yogurt
| Study group | Role | What they receive |
|---|---|---|
| Preschool Children age 4-6 years | Experimental | Preschool children participate in eating either an egg breakfast or a bagel breakfast. Receives: Other: Egg Breakfast; Other: Bagel Breakfast |
| Teenagers 14-17 years of age | Experimental | Teenagers participate in eating either an egg breakfast or a bagel breakfast. Receives: Other: Egg Breakfast; Other: Bagel Breakfast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lunch time food intake
Measure calories consumed at lunch time.
Measured: 1 day
Secondary outcomes (2)
Visual Analog Scale Ratings
They will be asked to rate their feelings of hunger and fullness periodically using visual analog scales. The Egg Breakfast is expected to increase satiety scores, decrease hunger and the lunch time food intake, compared to the Bagel Breakfast.
Measured: 1 day
Blood appetite hormone
We expect that Peptide YY (PYY) and Glucagon-like Peptide-1 (GLP1) levels will rise higher and remain elevated after the Egg Breakfast, and the acylated ghrelin levels will rise higher between the Bagle Breakfast and lunch time.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AppetiteStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Egg Nutrition Center
- Responsible party
- Sponsor
- Investigators
- Nikhil Dhurandhar, PhD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01530061
- Sponsor's protocol ID
- PBRC 12001
- Status last verified
- Sep 2022
- First submitted
- 7 Feb 2012
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Satiating Effect of Eggs in Children
- ClinicalTrials.gov ID
- NCT01530061
- Acronym / sponsor ID
- PBRC 12001
- Conditions
- Appetite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- Egg Nutrition Center
- Study start
- Feb 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 9 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine which breakfast (egg breakfast or bagel breakfast) has the most beneficial effect on appetite.
Detailed description
Test Day 1 (about 4 hours)
- This is a fasting visit (nothing besides water 12 hours prior to visit)
- Your child will be offered one of two breakfasts (egg breakfast or bagel breakfast) . He/she will be asked to eat all the food that is provided.
- He/she will be asked to rate the taste of the meal.
- He/she will be offered a pasta lunch.
Test Day 2 (about 4 hours)
- This will be scheduled 1 week after Test Day 1
- This is a fasting visit (nothing besides water 12 hours prior to visit)
- The procedures for this visit are the same as for Test Day 1. Your child will be offered the breakfast that he/she did not receive at the last visit.
The sequence of the 2 breakfasts will be randomly assigned to each child.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preschool Children age 4-6 years | Experimental | Other: Egg Breakfast, Other: Bagel BreakfastPreschool children participate in eating either an egg breakfast or a bagel breakfast. |
| Teenagers 14-17 years of age | Experimental | Other: Egg Breakfast, Other: Bagel BreakfastTeenagers participate in eating either an egg breakfast or a bagel breakfast. |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- • Is a healthy boy or girl between 14 and 17 years of age
Key exclusion criteria (4 listed)
- • Is suffering from any diseases such as major heart conditions, type 1 diabetes, cancer, eating disorders, or any serious illness that requires intensive and long-term medical treatment
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 |
|---|---|---|
| Egg BreakfastAlso: EggEgg, Toast and Jelly | Other | Preschool Children age 4-6 years, Teenagers 14-17 years of age |
| Bagel BreakfastAlso: BagelBagel, Cream Cheese and Yogurt | Other | Preschool Children age 4-6 years, Teenagers 14-17 years of age |
Primary outcome
Lunch time food intake
Time frame: 1 day
Measure calories consumed at lunch time.
2 secondary outcomes
Visual Analog Scale Ratings
Time frame: 1 day
Blood appetite hormone
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
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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.
Nikhil Dhurandhar, PhD 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 Egg Breakfast and Bagel Breakfast in people with Appetite, 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 2 inclusion and 4 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 15 Sep 2022. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Lunch time food intake (time frame: 1 day). 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 15 Sep 2022.