This study is a randomized, double-blind, placebo-controlled study of N=120 apparently healthy men and women. The purpose of this study is to assess the effect of a novel dietary supplement on blood markers of nutrient status, gut microbiome, and overall quality of life.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
105
A foundational nutritional supplement consisting of vitamins, minerals, probiotics, prebiotics, and whole food ingredients
Maltodextrin placebo
Citruslabs
Santa Monica, California, United States
Homocysteine
Circulating Serum Homocysteine Concentrations (umol/L)
Time frame: 90 days
Vitamin B12
Circulating Serum Vitamin B12 Concentrations (pg/mL)
Time frame: 90 days
Folate
Circulating Serum Folate Concentrations (ng/mL)
Time frame: 90 days
Red Blood Cell Folate
Circulating Red Blood Cell Folate Concentrations (nmol/L)
Time frame: 90 days
Zinc
Circulating Serum Zinc Concentrations (ug/dL)
Time frame: 90 days
Vitamin C
Serum Vitamin C Concentrations (
Time frame: 90 days
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: 90 days
Dietary habits
Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool
Time frame: 90 Days
Gastrointestinal Health
Gastrointestinal symptom rating scale (GSRS). Symptom score change after 90 days of administration, compared to Baseline. Score base on a 1-7 scale with a higher score meaning a worse outcome.
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Time frame: 90 Days
Fatigue & energy
Multidimensional Fatigue Inventory (MFI).The MFI is a 20-item instrument consisting of several subscales including general fatigue and reduced activity and will be assessed after 90 days of administration compared to baseline.
Time frame: 90 Days
Well-being
World Health Organization-5 Well-being Index Questionnaire.The World Health Organization-5 Well-Being Index is a brief scale, composed of five questions in which the participants indicate in each one of them, based on the last two weeks, the frequency of their sensations, being 0 (at no time) and 5 (all of the time). The result is given as the sum of the numbers of each statement, with values ranging from 0, which represents the worst possible quality of life and 25, which is associated with the best possible quality of life. Will be assessed at baseline and after 90 days of administration.
Time frame: 90 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: 90 Days
Complete Blood Count
Circulating concentrations of white blood cells, red blood cells, hemoglobin, and hematocrit
Time frame: 90 Days