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

Cornell University

Status: Active, not recruiting

Conditions: Nutrition, Healthy

Treatments: Dietary Supplement: non-DHA bio-enhanced chicken plus supplement DHA Omega-3; Dietary Supplement: non-DHA bio-enhanced eggs plus supplement DHA Omega-3; Other: non-25(OH)D fortified chicken/eggs plus placebo; Dietary Supplement: 25(OH)D bioenhanced chicken and eggs plus placebo; Dietary Supplement: non-25(OH)D fortified chicken/eggs plus vitamin D3 supplement; Dietary Supplement: Dietary Supplement: DHA/EPA fortified eggs plus Placebo; Dietary Supplement: DHA/EPA fortified chicken plus Placebo

Study type: Observational

Funder types: Other

Identifiers

NCT05248737

1904008786

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

84 participants in 2 patient groups

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

Description:

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.

Treatment:

Dietary Supplement: Dietary Supplement: DHA/EPA fortified eggs plus Placebo

Dietary Supplement: DHA/EPA fortified chicken plus Placebo

Dietary Supplement: non-DHA bio-enhanced eggs plus supplement DHA Omega-3

Dietary Supplement: non-DHA bio-enhanced chicken plus supplement DHA Omega-3

25(OH)D bioenhanced poultry and eggs

Description:

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.

Treatment:

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