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

NCT ID: NCT05248737

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 84 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-04
• Study Completion Date: 2026-01-30

Brief Summary

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.

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.

Conditions

Nutrition, Healthy

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

DHA/EPA fortified chicken plus Placebo

Intervention Type: DIETARY_SUPPLEMENT

For participants who received DHA/EPA fortified chicken

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

Intervention Type: DIETARY_SUPPLEMENT

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

Dietary Supplement: DHA/EPA fortified eggs plus Placebo

Intervention Type: DIETARY_SUPPLEMENT

For the participants who received DHA/EPA fortified eggs

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

Intervention Type: DIETARY_SUPPLEMENT

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.

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

Intervention Type: DIETARY_SUPPLEMENT

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

25(OH)D bioenhanced chicken and eggs plus placebo

Intervention Type: DIETARY_SUPPLEMENT

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

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

Intervention Type: OTHER

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

Interventions

DHA/EPA fortified chicken plus Placebo

For participants who received DHA/EPA fortified chicken

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DIETARY_SUPPLEMENT

Dietary Supplement: DHA/EPA fortified eggs plus Placebo

For the participants who received DHA/EPA fortified eggs

Intervention Type: 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

Intervention Type: DIETARY_SUPPLEMENT

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

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Human Metabolic Research Unit

Ithaca, New York, United States

Countries

United States

Other Identifiers

1904008786

Identifier Type: -

Identifier Source: org_study_id