Adolescents With Food InsecurityNCT03951883
Does Increased Egg Consumption Have Cognitive and Neural Benefits in Food Insecure, At-risk Adolescents?
A study testing Increased Egg Consumption and Typical diet in people with Adolescents With Food Insecurity, run by Texas Tech University at 2 sites in United States.
Trial summary
Quality nutrient intake is essential for proper development and well-being of children in all aspects of health, including cognitive development. Eggs are of particular interest based on potential cognitive and neurological benefits due in part to significant concentrations of choline and lutein. Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescents With Food Insecurity
- What is being tested?
- Increased Egg Consumption and Typical diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 May 2019to 1 Mar 2021
- 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 13 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age: 13-19 years.
- Household has food security status of low or very low as designated by scoring 2-6 raw score using the U.S. Household Food Security Survey Module: Six-Item Short Form.
Who cannot join
- Participants unable or unwilling to provide informed consent.
- Participants with motor, visual or hearing impairment.
- Participants with current severe psychiatric illnesses (e.g. psychosis, schizophrenia, bipolar disorders, depression)
- Participants with history of psychiatric hospitalization.
- Participants with habitual egg consumption (past 3 months) of 4 eggs per week or more
- Unable or unwilling to consume required study meals for any reason (e.g. dietary restrictions, allergies, or aversions to any of the food items used in the study).
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- History of liver or kidney disease, cardiovascular disease, hematologic disease, metabolic disease, Epilepsy (or other seizure disorder) or malignant tumor
- Currently taking (or have taken in the past 4 weeks) any anti-anxiolytic, anti-epileptic, or anti-depression medications
- Currently taking (or have taken in the past 4 weeks) any proton pump inhibitor medications
- History of any cognitive disorder, medical and/or psychological conditions and/or medications affecting cognition
- Participants with contraindications for MRI scanning.
- aneurism clips
- any implanted medical devices (pacemaker, neurostimulator)
- known pregnancy
- shrapnel in body or any injury to eye involving metal
- any ferrous metal in body
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Texas Tech Neuroimaging Institute
Lubbock, Texas, 79409
Nutrition & Metabolic Health Initiative
Lubbock, Texas, 79410
About this study
Quality nutrient intake is essential for proper development and well-being of children in all aspects of health, including cognitive development. Eggs are of particular interest based on potential cognitive and neurological benefits due in part to significant concentrations of choline and lutein. While overall, choline and lutein have received considerable attention in the literature in relation to cognition and brain function, most studies involving intake in young adults have had short intervention periods ranging from 90 minutes to 3 days. Food insecurity has been associated with decreased academic performance. Given that populations with food insecurity have limited resources to direct towards nutrition, identifying how a widely available, highly versatile and largely affordable source of nutrients (i.e. eggs) may have favorable impacts on cognitive function and brain function will be valuable in informing public health recommendations in this at-risk population. As such the investigators will examine whether an increased egg consumption dietary prescription can have positive effects on functional activity (i.e. fMRI) during an Eriksen-Flanker task, anatomical changes in the brain (i.e. DTI, MRI), and cognitive abilities as measured by the Stop Signal Reaction Time task, Operation Span task, Raven's Progressive Matrices and the Boston Naming Task.
- Conditions
- Adolescents With Food Insecurity
- Being tested
- Increased Egg Consumption, Typical diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increased Egg ConsumptionOther
Subjects will be instructed to use a weekly food purchase supplement for inclusion of 2 additional eggs per day to be added to subject's typical daily diet.
Typical dietOther
Subjects will be instructed to maintain their current dietary patterns.
| Study group | Role | What they receive |
|---|---|---|
| Typical Diet (TD) | Active comparator | Participants will be instructed to continue habitual dietary intake. Receives: Other: Typical diet |
| Increased Egg Consumption (IE) | Experimental | Participants will be prescribed an additional 2 eggs per day to their diet. Receives: Other: Increased Egg Consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of functional activity during Eriksen-Flanker Task
Changes in regional brain activation during an fMRI scan.
Measured: Baseline (pre-intervention) and 12 weeks (post-intervention)
Comparison of grey matter anatomical change
Grey density as measured by MRI
Measured: Baseline (pre-intervention) and 12 weeks (post-intervention)
Comparison of white matter connectivity change
White matter connectivity as measured by diffusion tensor imaging
Measured: Baseline (pre-intervention) and 12 weeks (post-intervention)
Comparison of cognitive battery performance change
Cognitive performance as measured by stop signal reaction time task
Measured: Baseline (pre-intervention) and 12 weeks (post-intervention)
Comparison of cognitive battery performance change
Cognitive performance as measured by operation span task
Measured: Baseline (pre-intervention) and 12 weeks (post-intervention)
Comparison of cognitive battery performance change
Cognitive performance as measured by Raven's Progressive Matrices
Measured: Baseline (pre-intervention) and 12 weeks (post-intervention)
Comparison of cognitive battery performance change
Cognitive performance as measured by Boston Naming Task
Measured: Baseline (pre-intervention) and 12 weeks (post-intervention)
Comparison of Eriksen-Flanker Task performance change
Eriksen-Flanker task performance compared using the drift diffusion model
Measured: Baseline (pre-intervention) and 12 weeks (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start1 May 2019
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescents With Food InsecurityStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University
- Sponsor type
- University, hospital or other
- Collaborators
- American Egg Board
- Responsible party
- Principal investigator, Martin Binks, Texas Tech University
- Investigators
- Martin Binks, PhD, Principal investigator, Texas Tech University- Department of Nutritional Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03951883
- Sponsor's protocol ID
- TTUIRB2019-160
- Status last verified
- Nov 2021
- First submitted
- 10 May 2019
- Last updated
- 11 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Increased Egg Consumption Have Cognitive and Neural Benefits in Food Insecure, At-risk Adolescents?
- ClinicalTrials.gov ID
- NCT03951883
- Acronym / sponsor ID
- TTUIRB2019-160
- Conditions
- Adolescents With Food Insecurity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Texas Tech UniversityUniversity, hospital or other
- Collaborators
- American Egg Board
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 16 May 2019 (actual)
- 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.
Quality nutrient intake is essential for proper development and well-being of children in all aspects of health, including cognitive development. Eggs are of particular interest based on potential cognitive and neurological benefits due in part to significant concentrations of choline and lutein. While overall, choline and lutein have received considerable attention in the literature in relation to cognition and brain function, most studies involving intake in young adults have had short intervention periods ranging from 90 minutes to 3 days. Food insecurity has been associated with decreased academic performance. Given that populations with food insecurity have limited resources to direct towards nutrition, identifying how a widely available, highly versatile and largely affordable source of nutrients (i.e. eggs) may have favorable impacts on cognitive function and brain function will be valuable in informing public health recommendations in this at-risk population. As such the investigators will examine whether an increased egg consumption dietary prescription can have positive effects on functional activity (i.e. fMRI) during an Eriksen-Flanker task, anatomical changes in the brain (i.e. DTI, MRI), and cognitive abilities as measured by the Stop Signal Reaction Time task, Operation Span task, Raven's Progressive Matrices and the Boston Naming Task.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Typical Diet (TD) | Active comparator | Other: Typical dietParticipants will be instructed to continue habitual dietary intake. |
| Increased Egg Consumption (IE) | Experimental | Other: Increased Egg ConsumptionParticipants will be prescribed an additional 2 eggs per day to their diet. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age: 13-19 years.
- Household has food security status of low or very low as designated by scoring 2-6 raw score using the U.S. Household Food Security Survey Module: Six-Item Short Form.
Key exclusion criteria (16 listed)
- Participants unable or unwilling to provide informed consent.
- Participants with motor, visual or hearing impairment.
- Participants with current severe psychiatric illnesses (e.g. psychosis, schizophrenia, bipolar disorders, depression)
- Participants with history of psychiatric hospitalization.
- Participants with habitual egg consumption (past 3 months) of 4 eggs per week or more
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 |
|---|---|---|
| Increased Egg ConsumptionSubjects will be instructed to use a weekly food purchase supplement for inclusion of 2 additional eggs per day to be added to subject's typical daily diet. | Other | Increased Egg Consumption (IE) |
| Typical dietSubjects will be instructed to maintain their current dietary patterns. | Other | Typical Diet (TD) |
Primary outcome
Comparison of functional activity during Eriksen-Flanker Task
Time frame: Baseline (pre-intervention) and 12 weeks (post-intervention)
Changes in regional brain activation during an fMRI scan.
Comparison of grey matter anatomical change
Time frame: Baseline (pre-intervention) and 12 weeks (post-intervention)
Grey density as measured by MRI
Comparison of white matter connectivity change
Time frame: Baseline (pre-intervention) and 12 weeks (post-intervention)
White matter connectivity as measured by diffusion tensor imaging
Comparison of cognitive battery performance change
Time frame: Baseline (pre-intervention) and 12 weeks (post-intervention)
Cognitive performance as measured by stop signal reaction time task
Comparison of cognitive battery performance change
Time frame: Baseline (pre-intervention) and 12 weeks (post-intervention)
Cognitive performance as measured by operation span task
Comparison of cognitive battery performance change
Time frame: Baseline (pre-intervention) and 12 weeks (post-intervention)
Cognitive performance as measured by Raven's Progressive Matrices
Comparison of cognitive battery performance change
Time frame: Baseline (pre-intervention) and 12 weeks (post-intervention)
Cognitive performance as measured by Boston Naming Task
Comparison of Eriksen-Flanker Task performance change
Time frame: Baseline (pre-intervention) and 12 weeks (post-intervention)
Eriksen-Flanker task performance compared using the drift diffusion model
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 11 Nov 2021.
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.
Martin Binks, PhD principal investigator
Texas Tech University- Department of Nutritional Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Increased Egg Consumption and Typical diet in people with Adolescents With Food Insecurity, run by Texas Tech University at 2 sites 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 16 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 11 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Comparison of functional activity during Eriksen-Flanker Task (time frame: Baseline (pre-intervention) and 12 weeks (post-intervention)). The study lists 8 primary outcomes in all. 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 11 Nov 2021.