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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The FEEDMe Study is a single-group, open label pilot study exploring how diverse, commercially available foods rich in arabinose influence the gut microbiome in adults from diverse populations.
Upon enrollment, healthy adults will enter a 15-day lead-in period during which they will refrain from consuming specific foods and collect a baseline stool sample. The intervention period will be on days 16-33 during which participants will consume study provided high-arabinose foods. The follow-up period will be on days 34-49 during which participants will no longer eat the study foods and will refrain from consuming specific foods. The total duration of the study will be approximately 7 weeks. Stool samples will be collected on 3 occasions and participants will be asked to complete questionnaires, daily stool logs, dietary intake reports, and 24-hour dietary recalls throughout the course of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre, during and post high arabinose foods intake | Experimental | All individuals will enter a lead-in period consisting of a low arabinose diet, then they will consume a high arabinose diet and then back to the low arabinose diet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High arabinose diet | Other | Participants will consume a high arabinose diet for 18 consecutive days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fecal microbiome | Examine changes to the concentration and distribution of fecal microbiota in response to consuming a high arabinose diet as measured by 16s rRNA sequencing and metagenomics. | Change from baseline to days 31 and 47 |
| Fecal glycome | Determine changes in fecal glycome in response to consumption of a high arabinose diet as measured by metagenomic analysis and mass spectrometry. | Change from baseline to days 31 and 47 |
| Fecal SCFAs | Determine changes in fecal SCFAs in response to consumption of a high arabinose diet as measured by mass spectrometry. | Change from baseline to days 31 and 47 |
| Gastrointestinal tolerance | Assess gastrointestinal tolerance to a high arabinose diet as measured by questionnaires that ask participants to report gastrointestinal symptoms. A list of GI symptoms are listed in the weekly survey and participants will select none, mild, moderate, severe or unsure. The proportion of severe responses will be compared across the study weeks. | Change from baseline to days 31 and 47 |
| Stool consistency and frequency | Determine changes in fecal consistency and frequency in response to a high arabinose diet as measured by questionnaires that ask participants to report their number of stools per day and to rank the consistency of their stools using the Bristol Stool Scale. For seven days prior to each of the three stool collections, participants will rate their stool consistency on a scale from 1-7 and these values will be averaged and compared across the three time points (pre, during and post high arabinose diet). This scale is not continuous but rather nominal and the proportion of 4 and 5 is considered "normal" stoo consistency. |
| Measure | Description | Time Frame |
|---|---|---|
| Fecal immune markers | Determine changes in fecal immune and inflammatory markers such as levels of immunoglobulins in response to a high arabinose diet as measured by ELISA and mass spectrometry. | Change from baseline to days 31 and 47 |
| Fecal metabolomics |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Endpoint 2 | Determine the feasibility of executing the study design in two different populations: 1) medium and high income and 2) low-income communities at-risk for gut dysbiosis by comparing attrition rates among the two groups. | Study period: Days 1-49 |
| Exploratory Endpoint 1 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Smilowitz, PhD | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California | Davis | California | 95616 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29757343 | Background | So D, Whelan K, Rossi M, Morrison M, Holtmann G, Kelly JT, Shanahan ER, Staudacher HM, Campbell KL. Dietary fiber intervention on gut microbiota composition in healthy adults: a systematic review and meta-analysis. Am J Clin Nutr. 2018 Jun 1;107(6):965-983. doi: 10.1093/ajcn/nqy041. | |
| 33208922 | Background | Gill SK, Rossi M, Bajka B, Whelan K. Dietary fibre in gastrointestinal health and disease. Nat Rev Gastroenterol Hepatol. 2021 Feb;18(2):101-116. doi: 10.1038/s41575-020-00375-4. Epub 2020 Nov 18. |
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| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Subjects will be enrolled and will consume study provided high arabinose foods during the intervention period.
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| Change from baseline to days 16-33 |
| Study food acceptability | Examine overall acceptability and sensory perceptions of high arabinose commercially available products as measured by questionnaires. Participants will rate how much they like each study food after consuming each one for the first time on a continuous scale from 0 to 100 where 0 equals did not like at all and 100 equals extremely liked. The scores will be reported for each food. | Intervention period: days 31-46 |
| Study expansion feasibility | Evaluate the overall satisfaction of participants' experience for feedback on the study protocol and study duration. At the end of the study, participants will rate their satisfaction on a continuous scale from 0 to 100, where 0 equals not satisfied at all and 100 equals extremely satisfied. | Study period: Days 1-49 |
| Follow-up period evaluation | Evaluate if 14 days of avoiding arabinose foods is a sufficient washout period to result in changes in concentration and distribution of gut microbiota as measured by 16s rRNA sequencing and metagenomics. | Follow-up period: days 34-49 |
Determine changes in fecal metabolites and organic acids in response to a high arabinose diet as measured by mass spectrometry. |
| Change from baseline to days 31 and 47 |
Determine the feasibility in adults consuming a high arabinose diet over 2.5 week period by assessing adherence to the study protocol and attrition rates. |
| Study period: Days 1-49 |
| Exploratory Endpoint 3 | Determine differences for all primary and secondary endpoints between middle/high income and low-income participants in response to a high arabinose diet by stratifying data based on these two groups. | Study period: Days 1-49 |
| Safety Endpoints | Determine if the study resulted in any Adverse Events and Serious Adverse Events by administering a questionnaire that asks participants to report the occurrence of any illness and health care visits for sickness. Participants complete weekly questionnaires and report if they experienced any illnesses or hospital visits. The proportion of these incidence will be reported across the three time points (pre, during and post high arabinose diet). | Study period: Days 1-49 |
| Background | U.S. Department of Agriculture USDoHaHS. Dietary Guidelines for Americans, 2020-2025. 2020(9th Edition). |
| 35458202 | Background | Castillo JJ, Couture G, Bacalzo NP Jr, Chen Y, Chin EL, Blecksmith SE, Bouzid YY, Vainberg Y, Masarweh C, Zhou Q, Smilowitz JT, German JB, Mills DA, Lemay DG, Lebrilla CB. The Development of the Davis Food Glycopedia-A Glycan Encyclopedia of Food. Nutrients. 2022 Apr 14;14(8):1639. doi: 10.3390/nu14081639. |
| 34163075 | Background | Delannoy-Bruno O, Desai C, Raman AS, Chen RY, Hibberd MC, Cheng J, Han N, Castillo JJ, Couture G, Lebrilla CB, Barve RA, Lombard V, Henrissat B, Leyn SA, Rodionov DA, Osterman AL, Hayashi DK, Meynier A, Vinoy S, Kirbach K, Wilmot T, Heath AC, Klein S, Barratt MJ, Gordon JI. Evaluating microbiome-directed fibre snacks in gnotobiotic mice and humans. Nature. 2021 Jul;595(7865):91-95. doi: 10.1038/s41586-021-03671-4. Epub 2021 Jun 23. |