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This study is a triple-blind, placebo-controlled, randomized controlled trial of 120 adults that will evaluate the impact of a novel nutritional supplement on improving nutrient gaps and changing nutrient status and the gut microbiome among glucagon-like peptide-1 receptor agonist (GLP-1 RA) users.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary Supplement: AG1 - Nutritional Supplement | Experimental | AG1 - Nutritional Supplement |
|
| Dietary Supplement: Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AG1 - Nutritional Supplement | Dietary Supplement | AG1 - Nutritional Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Nutrient Gaps | Assess nutrient gaps by dietary record assessment utilizing The Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Nutrient Status Markers | Circulating concentrations of nutrient status (homocysteine, folate, Vitamin A, Vitamin C, Vitamin D, Vitamin E, Thiamin, Riboflavin, Niacin, Vitamin B6, Vitamin B12, Zinc) | 90 days |
| Gut Microbiome |
| Measure | Description | Time Frame |
|---|---|---|
| GI Symptoms | 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 | 90 days |
| Digestive Quality of Life |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ellen O'Gorman | Contact | (805) 292-0714 | ellen@citruslabs.com | |
| Jodi Nicolli | Contact | jodi@citruslabs.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Citruslabs | Recruiting | Santa Monica | California | 90404-3727 | United States |
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| Placebo | Dietary Supplement | Maltodextrin Placebo |
|
Examine changes in the gut microbiome via fecal metagenomics
| 90 days |
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
| 90 days |
| Functional Impairment | The Sheehan Disability Scale will be utilized to assess functional impairment. | 90 days |
| Ingestive Behavior | Food cravings will be measured using the General Food Cravings Questionnaire. | 90 days |
| Energy | The Fatigue Assessment Scale will be utilized to assess the impact of the intervention on symptoms of fatigue. | 90 days |
| Serum concentrations of sodium | Measured using a Comprehensive Metabolic Panel | 90 days |
| Serum concentrations of Potassium | Measured in a Comprehensive Metabolic Panel | 90 days |
| Serum concentrations of carbon dioxide | Measured in a Comprehensive Metabolic Panel | 90 days |
| Serum concentrations of chloride | Measured in a Comprehensive Metabolic Panel | 90 days |
| Serum concentrations of albumin | Measured in a Comprehensive Metabolic Panel | 90 days |
| Serum concentrations of total protein | Measured in a Comprehensive Metabolic Panel | 90 days |
| Serum concentrations of glucose | Measured in a Comprehensive Metabolic Panel | 90 days |
| Serum concentrations of calcium | Measured in a Comprehensive Metabolic Panel | 90 days |
| Serum concentrations of ALT | Measured in a Comprehensive Metabolic Panel | 90 days |
| Serum concentrations of AST | Measured in a Comprehensive Metabolic Panel | 90 days |
| Serum concentrations of bilirubin | Measured in a Comprehensive Metabolic Panel | 90 days |
| Serum concentrations of Blood Urea Nitrogen | Measured in a Comprehensive Metabolic Panel | 90 days |