Diet, Nutrient Status, and Food Insecurity

Food Insecurity Clinical Trial

Official title:

The Effect of Dietary Supplementation on Nutrient Status in Families Living in a Food Insecure Environment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03412825
• Other study ID #: 70573
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: November 30, 2018

Study information

• Verified date: April 2019
• Source: University of Arkansas, Fayetteville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Food Insecurity

Intervention

Dietary Supplement:
• Egg supplementation
Participants will required to consume 2 eggs per day, 5 days a week (a total of 10 eggs per week).

Locations

Country	Name	City	State
United States	University of Arkansas	Fayetteville	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas, Fayetteville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Height	Height (in centimeters) will be measured using a stadiometer.	The change in height will be measured from baseline to 16 weeks.
Secondary	Weight	Weight (in kilograms) will be measured using a scale.	The change in weight will be measured from baseline to 16 weeks.
Secondary	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.