Food InsecurityNCT03412825
Diet, Nutrient Status, and Food Insecurity
A study testing Egg supplementation in people with Food Insecurity, run by University of Arkansas, Fayetteville at 1 site in United States.
Trial summary
Arkansas has one of the highest rates for food insecurity and 27.7% of children in the University of Arkansas area are food insecure. In addition, more than 14% of children ages 2-4 are obese and 20% of children ages 10-17 are obese. Read more about this study
- Who is it for?
- Ages 7 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Insecurity
- What is being tested?
- Egg supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2017to 30 Nov 2018
- 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 7 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Food insecurity assessed by use of SNAP benefits or qualifying using the US Food Security Scale).
Who cannot join
- No dietary restrictions
- Fear of needles
- Metabolic disorders
- Picky eating
- Taking medication
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas
Fayetteville, Arkansas, 72704
About this study
Official title: The Effect of Dietary Supplementation on Nutrient Status in Families Living in a Food Insecure Environment
Arkansas has one of the highest rates for food insecurity and 27.7% of children in the University of Arkansas area are food insecure. In addition, more than 14% of children ages 2-4 are obese and 20% of children ages 10-17 are obese. In Northwest Arkansas, the area surrounding the University of Arkansas in Fayetteville (Washington County), the food insecurity rate for adults is 17.9% (an estimated 34,730 individuals) and the food insecurity rate for children under 17 years of age is 24.4% (12,150 individuals). In addition, the surrounding counties have similar food insecurity rates (This makes Northwest Arkansas an ideal location to conduct a pilot study focusing on egg supplementation, childhood obesity, and food insecurity (http://www.feedingamerica.org/hunger-in-america/our-research/map-the-meal-gap).
- Conditions
- Food Insecurity
- Being tested
- Egg supplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Egg supplementationDietary supplement
Participants will required to consume 2 eggs per day, 5 days a week (a total of 10 eggs per week).
| Study group | Role | What they receive |
|---|---|---|
| Nutrition Supplementation | Experimental | Not described Receives: Dietary Supplement: Egg supplementation |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Micronutrient status in plasma
Micronutrients status will be measured using plasma samples.
Measured: The change in micronutrient status (e.g. iron, vitamin A, vitamin B12) will be measured from baseline to 16 weeks to determine if the dietary intervention improves baseline micronutrient status.
Body composition
Body composition will be measured using dual X-ray absorptiometry (DEXA) .
Measured: The change in body composition (e.g. ratio of lean to fat mass) will measured from baseline to 16 weeks.
Secondary outcomes (3)
Height
Height (in centimeters) will be measured using a stadiometer.
Measured: The change in height will be measured from baseline to 16 weeks.
Weight
Weight (in kilograms) will be measured using a scale.
Measured: The change in weight will be measured from baseline to 16 weeks.
Waist-to-hip ratio
Waist-to-hip ratio will be measured using the protocol outlined by the World Health Organization.
Measured: The change in waist-to-hip ratio will be measured from baseline to 16 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start1 Dec 2017
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas, Fayetteville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamie Baum, University of Arkansas, Fayetteville
- Investigators
- Jamie I Baum, PhD, Principal investigator, University of Arkansas, Fayetteville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03412825
- Sponsor's protocol ID
- 70573
- Status last verified
- Apr 2019
- First submitted
- 8 Jan 2018
- Last updated
- 26 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dietary Supplementation on Nutrient Status in Families Living in a Food Insecure Environment
- ClinicalTrials.gov ID
- NCT03412825
- Acronym / sponsor ID
- 70573
- Conditions
- Food Insecurity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Arkansas, FayettevilleUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 26 Jan 2018 (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.
Arkansas has one of the highest rates for food insecurity and 27.7% of children in the University of Arkansas area are food insecure. In addition, more than 14% of children ages 2-4 are obese and 20% of children ages 10-17 are obese. In Northwest Arkansas, the area surrounding the University of Arkansas in Fayetteville (Washington County), the food insecurity rate for adults is 17.9% (an estimated 34,730 individuals) and the food insecurity rate for children under 17 years of age is 24.4% (12,150 individuals). In addition, the surrounding counties have similar food insecurity rates (This makes Northwest Arkansas an ideal location to conduct a pilot study focusing on egg supplementation, childhood obesity, and food insecurity (http://www.feedingamerica.org/hunger-in-america/our-research/map-the-meal-gap).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutrition Supplementation | Experimental | Dietary Supplement: Egg supplementation |
| Control | No intervention | – |
Who may qualify
- Ages
- 7 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Food insecurity assessed by use of SNAP benefits or qualifying using the US Food Security Scale).
Key exclusion criteria (5 listed)
- No dietary restrictions
- Fear of needles
- Metabolic disorders
- Picky eating
- Taking medication
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 supplementationParticipants will required to consume 2 eggs per day, 5 days a week (a total of 10 eggs per week). | Dietary supplement | Nutrition Supplementation |
Primary outcome
Micronutrient status in plasma
Time frame: The change in micronutrient status (e.g. iron, vitamin A, vitamin B12) will be measured from baseline to 16 weeks to determine if the dietary intervention improves baseline micronutrient status.
Micronutrients status will be measured using plasma samples.
Body composition
Time frame: The change in body composition (e.g. ratio of lean to fat mass) will measured from baseline to 16 weeks.
Body composition will be measured using dual X-ray absorptiometry (DEXA) .
3 secondary outcomes
Height
Time frame: The change in height will be measured from baseline to 16 weeks.
Weight
Time frame: The change in weight will be measured from baseline to 16 weeks.
Waist-to-hip ratio
Time frame: The change in waist-to-hip ratio will be measured from baseline to 16 weeks.
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 26 Apr 2019.
- Individual participant dataSharing planned: No
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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.
Jamie I Baum, PhD principal investigator
University of Arkansas, Fayetteville
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 supplementation in people with Food Insecurity, run by University of Arkansas, Fayetteville 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 1 inclusion and 5 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 26 Apr 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. 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?
Micronutrient status in plasma (time frame: The change in micronutrient status (e.g. iron, vitamin A, vitamin B12) will be measured from baseline to 16 weeks to determine if the dietary intervention improves baseline micronutrient status.). The study lists 2 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 26 Apr 2019.