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| Name | Class |
|---|---|
| Citruslabs | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Maltodextrin + Flavoring |
|
| AG1 - Nutritional Supplement | Experimental | AG1, a foundational nutritional supplement |
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| 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 |
|---|---|---|
| Homocysteine | Circulating Serum Homocysteine Concentrations (umol/L) | 90 days |
| Vitamin B12 | Circulating Serum Vitamin B12 Concentrations (pg/mL) | 90 days |
| Folate | Circulating Serum Folate Concentrations (ng/mL) | 90 days |
| Red Blood Cell Folate | Circulating Red Blood Cell Folate Concentrations (nmol/L) | 90 days |
| Zinc | Circulating Serum Zinc Concentrations (ug/dL) | 90 days |
| Vitamin C | Serum Vitamin C Concentrations ( | 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. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Dietary habits | Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool | 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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Inclusion Criteria:
Exclusion Criteria:
>10% weight change in the last 6 months.
- Specific exclusion type diets like vegan, vegetarian, carnivore, paleo, atkins, ketogenic etc.
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| Name | Affiliation | Role |
|---|---|---|
| Ellen O'Gorman | Citruslabs | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Citruslabs | Santa Monica | California | 90404 | United States |
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Randomized, Double-Blind, Placebo Controlled Design
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| Placebo | Dietary Supplement | Maltodextrin placebo |
|
| 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. | 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. | 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 | 90 Days |
| Complete Blood Count | Circulating concentrations of white blood cells, red blood cells, hemoglobin, and hematocrit | 90 Days |