Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is a randomized, double-blind, placebo-controlled study of N=40 adult men and women with occasional GI issues. This study to assess the effect of a novel dietary supplement on the gut microbiome, nutrient gaps, and tolerability.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 via fecal metagenomics and metabolomics | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Nutrient Gaps | Assess nutrient gaps by dietary record assessment utilizing The Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Digestive Tolerability | 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 | 14 days |
| GI Tolerability |
To be eligible to participate in this study, an individual must meet all of the following criteria:
An individual who meets the following criteria will be excluded from participation in this study:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Citruslabs | Santa Monica | California | 90404-3727 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Randomized, Double-Blind, Placebo Controlled Design
Not provided
Not provided
Not provided
| Placebo | Dietary Supplement | Maltodextrin placebo |
|
The Gastrointestinal Symptom Rating Scale will be provided to assess the effect of the intervention on GI symptoms. Scores range from 1 to 7 with a higher score indicating a higher level of discomfort |
| 14 days |