Abstract
The purpose of this study was to validate the efficacy of a customized vitamin-mineral supplement on blood biomarkers in pre-menopausal females. Women (21–40 years old) who were apparently healthy were recruited from the local community (ClinicalTrials.gov trial registration NCT03828097). Pretesting (PRE) occurred in the morning 5 ± 2 days following each participant's menses and involved a fasted blood draw, body mass assessment, and blood pressure assessment. Participants were then randomly assigned in a double-blinded fashion to either the multivitamins (MV) (n = 43) or placebo group (n = 51). Participants consumed two capsules per day with breakfast for 12 weeks. Following the trial, participants reported to the laboratory for POST assessments, which replicated PRE procedures. Red blood cell fatty acid and serum micronutrient analyses were performed in a blinded fashion at hematology laboratories. A group × time interaction was observed for serum vitamin D levels (p < 0.001). MV increased levels from PRE to POST (+43.7%, p < 0.001), whereas no change occurred in the placebo group. Additionally, 78% of MV participants at PRE exhibited inadequate vitamin D levels (<40 ng/dl), whereas only 30% exhibited levels below this threshold at POST. An interaction was also observed for serum folate levels (p < 0.001). MV increased serum folate from PRE to POST (p < 0.001), whereas no change occurred in the placebo group. Red blood cell omega-3 fatty acid content increased from PRE to POST in the MV group (p < 0.001) and placebo group (p < 0.05), although POST values were greater in the MV group (p < 0.001). An interaction was observed for serum HDL cholesterol levels (p = 0.047), and a non-significant increase in this variable from PRE to POST occurred in the MV group (p = 0.060). Four-day food recalls indicated MV increased intake of omega-3 fatty acids, vitamin D, folate, and other micronutrients. In summary, MV supplementation increased serum vitamin D, serum folate, and red blood cell omega-3 fatty acid levels. However, these data are limited to healthy females, and more research is needed to examine if MV can affect metabolic disturbances in individuals with micronutrient deficiencies.
Highlights
Nutrient inadequacy is a public health concern in the U.S According to recent evidence, 31% of the U.S population may be at risk of at least one vitamin deficiency or anemia [1], with women among the most vulnerable groups
The current paper considered serum vitamin D levels below 40 ng/dl threshold to be suboptimal [16, 17] and the result showed that at prior to the 12-week supplement trial (PRE), 34/45 (76%) placebo participants and 31/40 (78%) MV participants had values below this threshold
We sought to examine if a novel multivitamin supplement, which contained omega-3 fatty acids, affected select serum micronutrient levels and red blood cell fatty acid profiles in premenopausal women during a 12-week supplementation period
Summary
Nutrient inadequacy is a public health concern in the U.S According to recent evidence, 31% of the U.S population may be at risk of at least one vitamin deficiency or anemia [1], with women among the most vulnerable groups. There is a debate regarding the efficacy of multivitamins as results from clinical studies have not been consistent [5,6,7,8,9] This inconsistency may be explained by the composition of products being tested that provide different nutrients, nonuniform forms of nutrients, and an array of dosages. The primary purpose of this study was to conduct a clinical trial to validate the efficacy of a multivitamin and omega-3 supplement (termed MV ), and determine whether 12 weeks of supplementation affected select serum micronutrient levels and red blood cell omega-3 fatty acid profiles in pre-menopausal women. We hypothesized that MV supplementation would increase red blood cell fatty acid levels compared to placebo supplementation
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