Diet, Nutrient Status, and Food Insecurity

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).

Study Overview

• Status: Completed
• Conditions: Food Insecurity
• Intervention / Treatment: Dietary supplement: Egg supplementation

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Fayetteville, Arkansas, United States, 72704
      • University of Arkansas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Food insecurity assessed by use of SNAP benefits or qualifying using the US Food Security Scale).

Exclusion Criteria:

• No dietary restrictions
• Fear of needles
• Metabolic disorders
• Picky eating
• Taking medication

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Nutrition Supplementation	Dietary supplement: Egg supplementation; Participants will required to consume 2 eggs per day, 5 days a week (a total of 10 eggs per week).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Micronutrient status in plasma	Micronutrients status will be measured using plasma samples.	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) .	The change in body composition (e.g. ratio of lean to fat mass) will measured from baseline to 16 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height	Height (in centimeters) will be measured using a stadiometer.	The change in height will be measured from baseline to 16 weeks.
Weight	Weight (in kilograms) will be measured using a scale.	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.	The change in waist-to-hip ratio will be measured from baseline to 16 weeks.

Collaborators and Investigators

• Sponsor: University of Arkansas, Fayetteville
• Investigators: Principal Investigator: Jamie I Baum, PhD, University of Arkansas, Fayetteville

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): November 30, 2018
• Study Completion (Actual): November 30, 2018

Study Registration Dates

• First Submitted: January 8, 2018
• First Submitted That Met QC Criteria: January 19, 2018
• First Posted (Actual): January 26, 2018

Study Record Updates

• Last Update Posted (Actual): April 26, 2019
• Last Update Submitted That Met QC Criteria: April 25, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 70573

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No