This study is a randomized, double-blind, placebo-controlled study of N=30 apparently healthy men and women. This is an exploratory study to assess the effect of a novel dietary supplement on blood markers of nutrient status and the gut microbiome.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
30
A foundational nutritional supplement consisting of vitamins, minerals, probiotics, prebiotics, and whole food ingredients
Maltodextrin placebo
Center for Applied Health Sciences
Canfield, Ohio, United States
Gut Microbiome
Examine changes in the gut microbiome structure and function measured by shallow shotgun metagenomics. Examine enrichment of taxa and metabolic pathways in the gut microbiome as a result of dietary supplementation.
Time frame: 28 days
Complete Metabolic Blood Panel
Serum concentrations of sodium, potassium, carbon dioxide, chloride, albumin, total protein, glucose, and calcium., ALT, AST, bilirubin, BUN, creatinine
Time frame: 28 Days
Complete Blood Count
Circulating concentrations of white blood cells, red blood cells, hemoglobin, and hematocrit
Time frame: 28 Days
Exploratory nutrient status markers
Circulating concentrations of nutrient status (e.gg, zinc, vitamin c, folate, \& magnesium)
Time frame: 28 days
Exploratory Digestive Measures
A Digestive Quality of Life Questionnaire (DQLQ) will be utilized to assess the effect of the interventions on participant's digestive health. Scores range from 0 to 9 with a higher score indicating worse digestion associated with quality of life
Time frame: 28 days
Exploratory Stool Consistency
Bristol Stool Scale (score 1-7) questionnaire that allows participants to identify how loose or hard their stool consistency is
Time frame: 28 days
Exploratory Stool Frequency
100mm Visual Analog Scale (VAS) to assess subjective ratings of stool consistency and frequency of bowl movements
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Time frame: 28 days