NCT03828097

The Effects of a Multi-vitamin Supplement in Adult Females

The Effects of a Multi-vitamin Supplement on Mood and Blood Markers in Adult Females Prior to and Following 12 Weeks of Supplementation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Auburn University · Academic / Other
• Sex: Female
• Age: 21 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Health, Subjective

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Experimental supplement	Subjects in both arms will consume two pills daily. Prior to and following 12 weeks of supplementation, participants will arrive to the laboratory following an overnight fast in order to donate blood as well as fill out EuroQoL and POMS questionnaires.
DIETARY_SUPPLEMENT	Placebo	Subjects in both arms will consume two pills daily. Prior to and following 12 weeks of supplementation, participants will arrive to the laboratory following an overnight fast in order to donate blood as well as fill out EuroQoL and POMS questionnaires.

Timeline

• Start date: 2018-05-01
• Primary completion: 2019-06-01
• Completion: 2019-06-01
• First posted: 2019-02-04
• Last updated: 2020-09-28

Locations

1 site across 1 country: United States