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Clinical Trial Summary

The investigators are examining how the daily consumption of a multi-vitamin/mineral supplement affects the following variables in 21-40 year old women:

1. blood levels of various micronutrients (assessed from blood draws using mass spectrometry-based assays)

2. blood cell gene expression patterns (assessed from blood draws and real-time PCR assays)

3. mood (assessed via questionnaires) Blood and questionnaires will be collected prior to supplementation, and 12 weeks into supplementation.


Clinical Trial Description

The investigators are testing the efficacy of a multi-vitamin/mineral/omega-3 complex on psychological and physiological measures in pre-menopausal women (21-40 years old) over a 12-week period.

This study will be a double-blinded, placebo-controlled intervention. Briefly, subjects will be screened for inclusion criteria. Eligible subjects will then undergo a pre-testing battery (i.e., T1) and will then be randomly assigned to one of two groups including:

1. Experimental group (anticipated n=50)

2. Control group (anticipated n=50) Subjects will then consume 2 capsules per day for 12 weeks and perform a post-testing battery (i.e., T2) that includes tests performed during the pre-testing battery.

Main outcome (dependent) variables between treatments will include:

1. blood levels of various micronutrients (assessed from blood draws using mass spectrometry-based assays)

2. blood cell gene expression patterns (assessed from blood draws and real-time PCR assays)

3. mood (assessed via questionnaires) Blood and questionnaires will be collected prior to supplementation, and 12 weeks into supplementation.

Statistics used to assess differences between conditions over time will include two-way repeated measures ANOVAs. When significant group*time interactions are observed, the statistical model will be decomposed using LSD post hoc tests. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03828097
Study type Interventional
Source Auburn University
Contact
Status Completed
Phase N/A
Start date May 1, 2018
Completion date June 1, 2019

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