Diet, Nutrient Status, and Food Insecurity

NCT03412825 | Completed

• 1 other identifier: 70573
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Height

  The change in height will be measured from baseline to 16 weeks.

• Weight

  The change in weight will be measured from baseline to 16 weeks.

• Waist-to-hip ratio

  The change in waist-to-hip ratio will be measured from baseline to 16 weeks.

Study Arms (2)

Nutrition Supplementation

EXPERIMENTAL

Dietary Supplement: Egg supplementation

Control

NO INTERVENTION

Interventions

Egg supplementation DIETARY_SUPPLEMENT

Participants will required to consume 2 eggs per day, 5 days a week (a total of 10 eggs per week).

Nutrition Supplementation

Eligibility Criteria

• Age: 7 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Arkansas, Fayetteville: lead

Study Sites (1)

University of Arkansas

Fayetteville, Arkansas, 72704, United States

Location

Study Officials

• Jamie I Baum, PhD

  University of Arkansas, Fayetteville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: January 26, 2018
• Study Start: December 1, 2017
• Primary Completion: November 30, 2018
• Study Completion: November 30, 2018
• Last Updated: April 26, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)