The Effects of a Novel Nutritional Product on Nutrient Status and Digestive Health

Study Overview
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Brief Summary
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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.

Official Title
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The Effects of a Novel Nutritional Product on Nutrient Status and Digestive Health

Conditions
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Gastrointestinal Microbiome, Nutrition, Healthy, Healthy Aging

Intervention / Treatment
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* Dietary Supplement: AG1 - Nutritional Supplement
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide voluntary signed and dated informed consent. Be in good health as determined by medical history and routine blood chemistries. Age between 18 and 50 yr (inclusive). Body Mass Index of 18.5-29.9 (inclusive). Body weight of at least 120 pounds. Normotensive (seated, resting systolic blood pressure <140 mm Hg and diastolic blood pressure < 90 mm Hg. If the first measurement is slightly elevated above these limits, the subject will be given a brief (5 minute) rest period, and two more measurements will be taken. The average of all three measurements will be used to determine eligibility. Normal seated, resting heart rate (<90 per minute). Willing to duplicate their previous 24-hour diet, refrain from caffeine and exercise for 24 hours prior to each visit, and fast for 10 hours prior to each visit. Subject agrees to maintain existing dietary and physical activity patterns throughout the study period. Subject is willing and able to comply with the study protocol. Exclusion Criteria: History of unstable or new-onset cardiovascular/cardiorespiratory, liver, or renal conditions. History of diabetes or endocrine disorder. History of use of medications or dietary supplements known to confound the study or its endpoints. Alcohol consumption (more than 2 standard alcoholic drinks per day or more than 10 drinks per week) or drug abuse or dependence within the past 6 months. Current smokers or smoking within the past month. History of hyperparathyroidism or an untreated thyroid condition. History of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin). Prior gastrointestinal bypass surgery (Lapband), etc. Other known gastrointestinal or metabolic conditions that might impact nutrient absorption or metabolism, e.g., short bowel syndrome, Irritable bowel syndrome (IBS), diarrheal illnesses, history of colon resection, gastro paresis, Inborn-Errors-of-Metabolism (such as PKU). Chronic inflammatory condition (e.g., rheumatoid arthritis, Crohn's, ulcerative colitis, Lupus, HIV/AIDS, etc.). Previous medical diagnosis of asthma, gout, or fibromyalgia. Pregnant women, women trying to become pregnant, women less than 120 days postpartum or nursing women. Women who participate in this study must agree to the use of contraception for the duration of the study and any woman that is sexually active will have to take a negative pregnancy test prior to enrolling. Women of childbearing age (any woman prior to menopause) regardless of their use of contraception will be provided a urine pregnancy test kit at their screening visit and take the test in private using the female lavatory after signing an informed consent. Known sensitivity to any ingredient in the test formulations as listed in the product label. Currently participating in another research study with an investigational product or have been in another research study in the past 30 days. Any other conditions that, in the opinion of the medical staff, could confound the primary endpoints or place the subject at increased risk of harm if they were to participate.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, Double-Blind, Placebo Controlled Design
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>12g Maltodextrin + Flavoring | Dietary Supplement: Placebo<br>* Maltodextrin placebo<br>|
| Experimental: AG1 - Nutritional Supplement<br>12g of AG1, a foundational nutritional supplement | Dietary Supplement: AG1 - Nutritional Supplement<br>* A foundational nutritional supplement consisting of vitamins, minerals, probiotics, prebiotics, and whole food ingredients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 
| Stool Consistency | Bristol Stool Scale (score 1-7) questionnaire that allows participants to identify how loose or hard their stool consistency is | 28 days | 
| Stool Frequency | 100mm Visual Analog Scale (VAS) to assess subjective ratings of stool consistency and frequency of bowl movements | 28 days | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |