Citruslabs
Santa Monica, California, 90404, United States
NCT Number: NCT06332898
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.
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Santa Monica, California, 90404, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
>10% weight change in the last 6 months.
A foundational nutritional supplement consisting of vitamins, minerals, probiotics, prebiotics, and whole food ingredients
Maltodextrin placebo
Time frame: 90 days
Circulating Serum Homocysteine Concentrations (umol/L)
Time frame: 90 days
Circulating Serum Vitamin B12 Concentrations (pg/mL)
Time frame: 90 days
Circulating Serum Folate Concentrations (ng/mL)
Time frame: 90 days
Circulating Red Blood Cell Folate Concentrations (nmol/L)
Time frame: 90 days
Circulating Serum Zinc Concentrations (ug/dL)
Time frame: 90 days
Serum Vitamin C Concentrations (
Time frame: 90 days
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
Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool
Time frame: 90 Days
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.
Time frame: 90 Days
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
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
Serum concentrations of sodium, potassium, carbon dioxide, chloride, albumin, total protein, glucose, and calcium., ALT, AST, bilirubin, BUN, creatinine
Time frame: 90 Days
Circulating concentrations of white blood cells, red blood cells, hemoglobin, and hematocrit
Athletic Greens International
Industry
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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