Effect of Nutrition Coaching and Supplements on Gut Microbiome

Study Overview
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Brief Summary
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The objective of this study is to test whether dietary behavior modification, a daily GRAS approved prebiotic/probiotic dietary supplement, and the combination of both will impact diet quality and stool microbiome composition and function using whole genome sequencing, targeted metabolomics and immune profiling. 400 healthy adults 18-64 years old will be assigned to one of 4 cohorts, with approximately 100 participants in each: Cohort 1 will serve as the control group without any directed dietary modifications. Cohort 2 participants will receive dietatian-led nutritional coaching via 5 Telenutrition (TN) visits with a registered dietitian (RD), utilizing the Academy of Nutrition and Dietetics' Nutrition Care Process. Cohort 3 participants will be given a once-daily, GRAS approved prebiotic/probiotic dietary supplement for 4 months, beginning within 2 weeks of the initial stool sample. Cohort 4 participants will receive both nutritional coaching and the prebiotic/probiotic dietary supplement. Stool samples will be obtained for each subject at baseline and end of study. Whole genome sequencing, metabolite analysis, and immune profiling will be performed on the samples. Demographic data, general health information, diet and lifestyle information will be collected from the subjects (all self-reported). When applicable, notes from telenutrition appointments will also be collected. Diet information will be collected using the Picture Your Plate(TM) validated food questionnaire.

Official Title
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Ambrosia: Evaluating the Effects of Nutrition Coaching, Diet Quality and Dietary Supplements on Gut Microbiome Analysis

Conditions
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Impact of Diet and Supplements on Gut Microbiome Composition

Intervention / Treatment
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* Behavioral: Nutrition Counseling
* Dietary Supplement: Prebiotic/Probiotic Supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to provide stool samples at study start and after approximately 5 months Willing and able to undergo online virtual nutrition coaching and/or take a daily, GRAS approved prebiotic/probiotic dietary supplement regimen for 4 months, based on cohort assignment Willing to complete online questionnaires concerning diet and lifestyle, in English Competency in spoken and written English Can provide written informed consent Exclusion Criteria: Subjects with known HIV, Hepatitis A, Hepatitis B, Hepatitis C Known Familial Adenomatous Polyposis or Lynch Syndrome (aka Hereditary Non-Polyposis Colorectal Cancer or HNPCC) diagnosis A history of Crohn's Disease, Inflammatory Bowel Disease, or chronic colitis. Active cancer in the past 2 years, or currently undergoing any form of cancer therapy. Currently being treated for diabetes. Confirmed case of COVID-19 or influenza within one month prior to enrollment Oral or systemic antibiotic or probiotic use, or a known GI infection, within 3 months prior to enrollment Engaged in a nutritional or dietary intervention in the past 3 months. Confirmed case of COVID-19 or influenza within one month prior to enrollment Known Familial Adenomatous Polyposis or Lynch Syndrome (aka Hereditary Non-Polyposis Colorectal Cancer or HNPCC) diagnosis Active non-CRC malignancy in the past 2 years, or currently undergoing any form of cancer therapy. Women who are pregnant or plan to become pregnant in the next 6 months, or currently nursing.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Directed Dietary Intervention<br>Control group without any directed dietary modifications | |
| Experimental: Nutrition Coaching<br> | Behavioral: Nutrition Counseling<br>* Dietitian-led nutrition coaching via 5 Telenutrition visits, utilizing the Academy of Nutrition and Dietetics' Nutrition Care Process.<br>|
| Experimental: Prebiotic/Probiotic Dietary Supplement<br> | Dietary Supplement: Prebiotic/Probiotic Supplement<br>* A once-daily, GRAS prebiotic/probiotic dietary supplement for 4 months, beginning within 2 weeks of the initial stool sample.<br>|
| Experimental: Combination<br> | Behavioral: Nutrition Counseling<br>* Dietitian-led nutrition coaching via 5 Telenutrition visits, utilizing the Academy of Nutrition and Dietetics' Nutrition Care Process.<br>Dietary Supplement: Prebiotic/Probiotic Supplement<br>* A once-daily, GRAS prebiotic/probiotic dietary supplement for 4 months, beginning within 2 weeks of the initial stool sample.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutrition Counseling Microbiome Impact | Measure microbiome composition before and after 5 telenutrition visits by whole genome sequencing, and determine change in microbial composition as indicated by gUnifrac distance between the two datapoints. | 4 months | 
| Prebiotic/Probiotic Microbiome Impact | Measure microbiome composition before and after 4 months of daily dosing with a prebiotic/probiotic cocktail by whole genome sequencing, and determine change in microbioal composition as indicated by gUnifrac distance between the two datapoints. | 4 months |