Supplementation of Cholecalciferol and Related Active Metabolites Through Bioenhancing Layer's Eggs
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorCornell University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy adults
Non-smoking
Age between 18- 40 years
Females: premenopausal and not pregnant or lactating
Disqualifiers
BMI <18.5 or > 27.0 kg/m2,
Age <18 y or > 40y,
Smoking
Pregnancy, lactating
Trial design
Design model
Parallel
Treatments tested in this trial
Vitamin D3 bioenhanced eggs
Dietary supplementSix vitamin D3-fortified eggs per week will be provided to participants to consume each week for 8 weeks
25(OH)D3 bioenhanced eggs
Dietary supplementSix 25(OH)D3-fortified eggs will per week be provided to participants to consume each week for 8 weeks.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Vitamin D3 bioenhanced eggsExperimental treatment 1 intervention
Group B: 25(OH)D3 bioenhanced eggsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Vitamin D Status
Serum concentrations of vitamin D2, vitamin D3, 25(OH)D2, 25(OH)D3, 1,25(OH)2D2, 1,25(OH)2D3, 24,25(OH)2D3, and vitamin D binding protein concentration will be measured biweekly over 8 weeks to assess vitamin D and 25(OH)D bioavailability.
Time frame
Baseline, and time course of week 2, week 4, week 6, week 82
Gut microbiome composition
Fecal samples will be collected for metagenomic analyses to evaluate the impact of vitamin D or 25(OH)D status and intake on the gut microbiome.
Time frame
Baseline, week 4, week 8Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov