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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Maltodextrin + Flavoring |
|
| AG1 - Nutritional Supplement | Experimental | A foundational nutritional supplement consisting of vitamins, minerals, probiotics, prebiotics, and whole food ingredients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AG1 - Nutritional Supplement | Dietary Supplement | A foundational nutritional supplement consisting of vitamins, minerals, probiotics, prebiotics, and whole food ingredients |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Metabolic Blood Panel | Serum concentrations of sodium, potassium, carbon dioxide, chloride, albumin, total protein, glucose, and calcium., ALT, AST, bilirubin, BUN, creatinine | 28 Days |
| Complete Blood Count |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Applied Health Sciences | Canfield | Ohio | 44046 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39352252 | Derived | La Monica MB, Raub B, Hartshorn S, Gustat AL, Grdic J, Kirby TO, Townsend JR, Sandrock J, Ziegenfuss TN. The effects of AG1(R) supplementation on the gut microbiome of healthy adults: a randomized, double-blind, placebo-controlled clinical trial. J Int Soc Sports Nutr. 2024 Dec;21(1):2409682. doi: 10.1080/15502783.2024.2409682. Epub 2024 Oct 1. |
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Randomized, Double-Blind, Placebo Controlled Design
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| Placebo | Dietary Supplement | Maltodextrin placebo |
|
Circulating concentrations of white blood cells, red blood cells, hemoglobin, and hematocrit
| 28 Days |
| Exploratory nutrient status markers | Circulating concentrations of nutrient status (e.gg, zinc, vitamin c, folate, & magnesium) | 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 | 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 | 28 days |
| Exploratory Stool Frequency | 100mm Visual Analog Scale (VAS) to assess subjective ratings of stool consistency and frequency of bowl movements | 28 days |