The goal of this clinical trial is to investigate the effects multivitamin (MVM) on blood biomarkers that are associated with healthy pregnancy and conception in adult women. The main question it aims to answer is: Is there a significant change in blood biomarkers from baseline (week 0) to end of intervention (week 12) in healthy women consuming multivitamin compared to participants consuming the placebo product? Participants will: Take drug MVM or a placebo every day for 12 weeks Visit the clinic at baseline and 12 weeks for serum blood draws and measurements Complete a series of surveys at baseline and 12 weeks
A 12 week double-blind, placebo-controlled, clinical trial assessing the daily administration of a multivitamin (MVM) or placebo on blood biomarkers associated with healthy pregnancy and conception in healthy adult women. Participants will consume study product or placebo for 12 weeks. Measurements will be taken at baseline and at the end of 12 weeks. Primary Objective: To evaluate in healthy women, the effect of 12-week long daily administration of a multivitamin (MVM) on blood biomarkers associated with healthy pregnancy (Folate). Secondary Objective: To evaluate in healthy women, the effect of 12-week long daily administration of multivitamin (MVM) on blood biomarkers associated with healthy pregnancy * Vitamin B12 * Iron * Omega-3 * Choline * CoQ10
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
4 capsules of Perelel Health Conception Support Multivitamin Pack (consisting of vitamins, minerals, and omega ingredients) consumed daily for 12 weeks
4 placebo capsules consumed daily for 12 weeks
Atlantia Food Clinical Trials
Cork, Munster, Ireland
Change from baseline (week 0) to end of intervention (week 12) on Serum Folate
Time frame: 12 weeks
Change from baseline (week 0) to end of intervention (week 12) on Serum Iron [including Ferritin, Total Iron Binding Capacity (TIBC) and Transferrin]
Time frame: 12 weeks
Change from baseline (week 0) to end of intervention (week 12) on Serum Vitamin B12
Time frame: 12 weeks
Change from baseline (week 0) to end of intervention (week 12) on Ratio Omega 6: Omega 3 (calculated)
Time frame: 12 weeks
Change from baseline (week 0) to end of intervention (week 12) on RBC Fatty Acid of Omega-3(DHA and EPA) and Omega-6 (CLA and AA)
Time frame: 12 weeks
Change from baseline (week 0) to end of intervention (week 12) on plasma Choline
Time frame: 12 weeks
Change from baseline (week 0) to end of intervention (week 12) on plasma CoQ10
Time frame: 12 weeks
Change from baseline (week 0) to end of intervention (week 12) on serum C-Reactive Protein (CRP)
Time frame: 12 weeks
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