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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Nutrition, Healthy
• Intervention / Treatment: Dietary supplement: DHA/EPA fortified chicken plus Placebo; Dietary supplement: non-DHA bio-enhanced chicken plus supplement DHA Omega-3; Dietary supplement: Dietary Supplement: DHA/EPA fortified eggs plus Placebo; Dietary supplement: non-DHA bio-enhanced eggs plus supplement DHA Omega-3; Dietary supplement: non-25(OH)D fortified chicken/eggs plus vitamin D3 supplement; Dietary supplement: 25(OH)D bioenhanced chicken and eggs plus placebo; Other: non-25(OH)D fortified chicken/eggs plus placebo

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 84

Contacts and Locations

Study Locations

• United States
  • New York
    • Ithaca, New York, United States, 14850
      • Human Metabolic Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 24 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Healthy adults from Ithaca, NY

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
DHA bioenhanced poultry/eggs or non-fortified poultry/eggs; In this study a group of individuals will be recruited and randomized to participate in a crossover comparing DHA enhanced poultry or control (non-fortified) poultry or to compare DHA enhanced eggs to control (non-fortified) eggs. Group 1: Participants will be asked to consume two meals of chicken, one meal will contain chicken that has been fed omega-3 fatty acids so the chicken contains omega 3 (DHA/EPA) fatty acids, together with a placebo, and the other meal will consist of non enhanced chicken and a DHA supplement. Group 2: Participants will be asked to consume two meals of eggs, one meal will contain DHA bioenhanced eggs, together with a placebo, and the other meal will consist of non enhanced eggs and a DHA supplement. Each participant will be asked to eat both of these forms of chicken in random order. Each study is expected to take 9-hours and the two visits will be separated by a period of two weeks. A total of 5 blood samples will be collected over a 9-h period.	Dietary supplement: DHA/EPA fortified chicken plus Placebo; For participants who received DHA/EPA fortified chicken; Dietary supplement: non-DHA bio-enhanced chicken plus supplement DHA Omega-3; Used in the crossover part of the study given to the group who did not received DHA bio-enhanced chicken; Dietary supplement: Dietary Supplement: DHA/EPA fortified eggs plus Placebo; For the participants who received DHA/EPA fortified eggs; Dietary supplement: non-DHA bio-enhanced eggs plus supplement DHA Omega-3; for the participants who received non-DHA bio-enhanced eggs plus supplement DHA Omega-3
25(OH)D bioenhanced poultry and eggs; 25D3 Group: Weeks 0-4: Consume 5 weekly servings of 25(OH)D-enhanced chicken (300 g/serving; 1,500 g/week) + daily placebo Weeks 5-8: + additional 5 weekly 25(OH)D-enhanced eggs Placebo Group: Weeks 0-4: Consume 5 weekly servings of control chicken + daily placebo Weeks 5-8: + additional 5 weekly control eggs D3 Group: Weeks 0-4: Consume 5 weekly servings of control chicken + daily vitamin D3 (1000 IU). Weeks 5-8: + additional 5 weekly control eggs Participation in the study is expected to last 8 weeks. Individuals will be asked to come to the Human Metabolic Research Unit (HMRU) on the Cornell campus each week to pick up weekly food supplies. At five timepoints during the 8-week study, a blood draw will be collected to measure vitamin D status and other markers (e.g., hemoglobin, hematocrit, blood lipids). Each blood draw visit will take approximately 30 minutes. The total estimated time for all study visits at the HMRU is 6-7 hours over the 8-week period.	Dietary supplement: non-25(OH)D fortified chicken/eggs plus vitamin D3 supplement; Provided to participants in the group where they consumed non-fortified chicken/eggs; Dietary supplement: 25(OH)D bioenhanced chicken and eggs plus placebo; participants will receive 25(OH)D bioenhanced chicken and eggs plus a placebo as a dietary intervention; Other: non-25(OH)D fortified chicken/eggs plus placebo; Provided to participants in the group where they consumed non-fortified chicken/eggs + placebo pills

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of plasma DHA concentrations	Measuring plasma DHA concentration across different time points to assess DHA bioavailability and absorption	Baseline, and time course of 1 hour, 2 hour, 4 hour and 8 hour post meal
Concentrations of serum 25(OH)D, vitamin D2, vitamin D3, 1,25(OH)2D and 24,25(OH)2D3 and vitamin D binding protein	Measuring serum 25(OH)D concentration across different time points to assess 25(OH)D bioavailability and absorption	Baseline, and time course of week 2, week 4, week 6, week 8

Collaborators and Investigators

• Sponsor: Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2021
• Primary Completion (Actual): December 11, 2024
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: February 7, 2022
• First Submitted That Met QC Criteria: February 16, 2022
• First Posted (Actual): February 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Vitamin D; Omega-3 fatty acids
• Additional Relevant MeSH Terms: Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Eggs
• Other Study ID Numbers: 1904008786

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
• product manufactured in and exported from the U.S.: No