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NCT Number: NCT05248737

Bioavailability of Vitamin D(25(OH)D) and Omega-3 Fatty Acid (DHA) Enhanced Chicken

The purpose of the research is to evaluate if chicken or eggs obtained from chickens that are fed a diet that contains omega-3 fatty acids (DHA/EPA), or vitamin D (as 25(OH)D) provides additional health benefits by improving the status of omega-3 fatty acids or 25(OH)D in healthy adults who eat this bioenhanced chicken or eggs.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Human Metabolic Research Unit

Ithaca, New York, 14850, United States

About this study

The 2015-2020 Dietary Guidelines advocate intake of lean proteins (such as chicken and fish) while limiting intake of saturated fat. Chicken contains similar protein to beef or pork but has less saturated fat. However, chicken, like other terrestrial meats, has little omega-3 polyunsaturated fatty acids such as docosahexaenoic acid (DHA) or eicosapentaenoic acid (EPA) and relatively little vitamin D. Vitamin D insufficiency is common in the US and globally, and has been linked to a number of adverse health outcomes. Vitamin D is ingested primarily from fortified dairy products, but recent animal studies have increased the D content of pork and beef, and the DHA content of chicken and of eggs produced from bioenhanced chickens. Moreover, sunlight exposure alone can enhance the 25(OH)D content of chicken. Notably, supplemental 25(OH)D is more effective than vitamin D at improving vitamin D status in humans, but little is known about the bioavailability of 25(OH)D or DHA/EPA enhanced chicken (muscle) or in enhanced eggs produced from supplemented chickens.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy adults
  • Non-smoking
  • Age between 18- 35 yo
  • Females: premenopausal and not pregnant or lactating
  • Body mass index (BMI) between 18 - 30 kg/m2.
  • No preexisting medical complications (such as eating disorders, gastrointestinal disorders, malabsorption diseases, or taking medications known to influence iron homeostasis)

Exclusion criteria

  • BMI <18 or > 30 kg/m2,
  • Age <18 y or > 50y,
  • Smoking
  • Pregnancy, lactating
  • Have gastrointestinal disorders/malabsorption diseases/dietary restrictions/medication use of medications known to impact DHA/EPA or Vitamin D 25(OH)D absorption
  • Take vitamin and mineral supplementations

Treatment and study plan

DHA/EPA fortified chicken plus Placebo

Dietary Supplement

For participants who received DHA/EPA fortified chicken

non-25(OH)D fortified chicken/eggs plus vitamin D3 supplement

Dietary Supplement

Provided to participants in the group where they consumed non-fortified chicken/eggs

non-DHA bio-enhanced chicken plus supplement DHA Omega-3

Dietary Supplement

Used in the crossover part of the study given to the group who did not received DHA bio-enhanced chicken

25(OH)D bioenhanced chicken and eggs plus placebo

Dietary Supplement

participants will receive 25(OH)D bioenhanced chicken and eggs plus a placebo as a dietary intervention

Dietary Supplement: DHA/EPA fortified eggs plus Placebo

Dietary Supplement

For the participants who received DHA/EPA fortified eggs

non-DHA bio-enhanced eggs plus supplement DHA Omega-3

Dietary Supplement

for the participants who received non-DHA bio-enhanced eggs plus supplement DHA Omega-3

non-25(OH)D fortified chicken/eggs plus placebo

Other

Provided to participants in the group where they consumed non-fortified chicken/eggs + placebo pills

Primary outcomes

  1. Concentration of plasma DHA concentrations

    Time frame: Baseline, and time course of 1 hour, 2 hour, 4 hour and 8 hour post meal

    Measuring plasma DHA concentration across different time points to assess DHA bioavailability and absorption

  2. Concentrations of serum 25(OH)D, vitamin D2, vitamin D3, 1,25(OH)2D and 24,25(OH)2D3 and vitamin D binding protein

    Time frame: Baseline, and time course of week 2, week 4, week 6, week 8

    Measuring serum 25(OH)D concentration across different time points to assess 25(OH)D bioavailability and absorption

Sponsors and collaborators

Lead sponsor

Cornell University

Other

Registry information

Official study title

Empowering and Transforming the US Broiler Production for Growth, Profit and Sustainability

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Feb 21, 2022
Registry last updated
Apr 1, 2026

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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