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

NCT05248737 | Active Not Recruiting

• 1 other identifier: 1904008786
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Nutrition, Healthy

Keywords

Vitamin D; Omega-3 fatty acids

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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; 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

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; Dietary Supplement: 25(OH)D bioenhanced chicken and eggs plus placebo; Other: non-25(OH)D fortified chicken/eggs plus placebo

Interventions

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

25(OH)D bioenhanced poultry and 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

DHA bioenhanced poultry/eggs or non-fortified poultry/eggs

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

25(OH)D bioenhanced poultry and eggs

Dietary Supplement: DHA/EPA fortified eggs plus Placebo DIETARY_SUPPLEMENT

For the participants who received DHA/EPA fortified eggs

DHA bioenhanced poultry/eggs or non-fortified poultry/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

DHA bioenhanced poultry/eggs or non-fortified poultry/eggs

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

25(OH)D bioenhanced poultry and eggs

DHA/EPA fortified chicken plus Placebo DIETARY_SUPPLEMENT

For participants who received DHA/EPA fortified chicken

DHA bioenhanced poultry/eggs or non-fortified poultry/eggs

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy adults from Ithaca, NY

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Cornell University: lead

Study Sites (1)

Human Metabolic Research Unit

Ithaca, New York, 14850, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and serum samples

MeSH Terms

Interventions

Eggs

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: February 21, 2022
• Study Start: December 4, 2021
• Primary Completion: December 11, 2024
• Study Completion (Estimated): May 30, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)