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OpenTrials
Completed

NCT Number: NCT03412825

Diet, Nutrient Status, and Food Insecurity

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).

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Key information

Conditions

Food Insecurity

Age range

7 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arkansas

Fayetteville, Arkansas, 72704, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Egg Supplementation

Dietary Supplement

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

Primary outcomes

  1. 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.

  2. 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) .

Secondary outcomes

  1. Height

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

    Height (in centimeters) will be measured using a stadiometer.

  2. Weight

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

    Weight (in kilograms) will be measured using a scale.

  3. Waist-to-hip ratio

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

    Waist-to-hip ratio will be measured using the protocol outlined by the World Health Organization.

Sponsors and collaborators

Lead sponsor

University of Arkansas, Fayetteville

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 26, 2018
Registry last updated
Apr 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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