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NCT07859280NARecruitingAccepts Healthy Volunteers

Supplementation of Cholecalciferol and Related Active Metabolites Through Bioenhancing Layer's Eggs

Cornell University

Start Date

1/1/2027

Completion Date

12/1/2029

Summary

The purpose of this research is to evaluate if 1) consumption of vitamin D3- or 25(OH)D3-biofortified eggs will increase vitamin D and 25(OH)D status in young adults who consume these bioenhanced eggs, 2) to determine if the gut microbiome profile is associated with 25(OH)D or vitamin D status and 3) to evaluate possible changes in the gut microbiome following an 8-week supplementation period providing 5(OH)D- or vitamin D bioenhanced eggs.

Detailed Description

In the wintertime, decreased UVB exposure limits vitamin D synthesis. Vitamin D insufficiency is common in the US and globally, with insufficiency evident in 41% of US adults over the age of 18 years, and has been linked to several adverse health outcomes. While dairy products are the major source of dietary vitamin D intake for the US public, little attention has been placed on other animal products (meat or eggs) as a source of vitamin D3 and 25(OH)D3. Determining the bioavailability of vitamin D-fortified eggs can inform updated dietary guidelines. Decreased 25(OH)D status has also been associated with a less diverse gut microbiome. Additionally, little attention has been given to how bioenhanced foods containing vitamin D3 or 25(OH)D3 may differentially shape the gut microbiome and thus human vitamin D metabolism. Prior research shows a strong correlation between 1,25(OH)2D3 concentration and gut microbial diversity in elderly men. Further research will help inform recommendations that address the efficacy of the form of vitamin D ingested from food products and how vitamin D status may shape the gut microbiota.

Eligibility Criteria

Age Range: 18 years to 40 years

Inclusion Criteria: * Healthy adults * Non-smoking * Age between 18- 40 years * Females: premenopausal and not pregnant or lactating * Body mass index (BMI) between 18.5-27.0 kg/m2. * No planned trip(s) to lower latitudes during the 8-week study Exclusion Criteria: * BMI \<18.5 or \> 27.0 kg/m2, * Age \<18 y or \> 40y, * Smoking * Pregnancy, lactating * Have gastrointestinal disorders/malabsorption diseases/dietary restrictions/use of medications known to impact vitamin D and 25(OH)D absorption * Been prescribed antibiotics within 3 months before enrolling * History or current diagnosis of any of the following conditions: intestinal problems (cystic fibrosis, Crohn's Disease, IBD, etc.), blood disorders (sickle cell, thalassemia, etc.), stomach problems (ulcers or other problems requiring antacids), joint diseases requiring anti-inflammatory medication, or asthma. * Planned trip(s) to lower latitudes during the 8-week study

Interventions

DIETARY_SUPPLEMENT

Vitamin D3 bioenhanced eggs

DIETARY_SUPPLEMENT

25(OH)D3 bioenhanced eggs

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Conditions

Healthy Adult ParticipantsVitamin D Insufficiency

Locations

Human Metabolic Research Unit

Ithaca, New York 14850

United States