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All subjects will complete a 49-day, multi-phase feeding study to evaluate the effect of pea fiber supplementation on gut community structure and features of host biological state (plasma proteome/ metabolome). Subjects will be asked to continue to consume their habitual diet (free diet phase) for 4 days prior to being provided with a diet high in saturated fat (HiSF) and low in fruits and vegetables (LoFV) in the form of packed-out meals and snacks to consume for the following 45 days. Ten days after starting to consume the HiSF-LoFV diet, subjects will supplement their diet with pea fiber for a total of 21 days; the energy contribution from the HiSF-LoFV diet will be reduced accordingly to maintain energy needs during this time. After completing the pea fiber supplementation phase of the study subjects will revert back to consuming the HiSF-LoFV only diet for the final 14 days. Stool, urine and blood will be sampled periodically throughout.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diet intervention | Experimental | All participants will stay weight stable while undergoing 3 phases of a dietary intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low fiber diet | Other | Participants will be provided with a low fiber diet in the form of packed out meals and snacks for 24 days in total (days 5-14 and days 36-49) |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in plasma lipid profile as assessed by the complete metabolic panel and lipid panel. | Blood will be drawn for the complete metabolic panel and lipid panel | At screening, day 14, day 35, and day 49 |
| Changes to the gut microbiota as assessed by established culture independent methods, as well as LC-QTOF Mass-Spectometry (MS) and LC-QQQ MS and GC-MS | Frequent stool samples will be collected throughout the entire study | stool samples will be collected from the screening visit through the final day of the 49-day intervention |
| Changes in urine proteomes and metabolomes as assessed by liquid chromatography | First morning urine samples will be collected periodically throughout the study | Daily or every other day first-morning urine samples will be collected from day 1 to day 49 of the study |
| Changes in plasma proteomes and metabolomes as assessed by liquid chromatography | fasting blood draws will be collected periodically throughout the study | Fasted blood draws will be collected on days 1, 14, 21, 28, 35, and 49 of the study |
| Change in hemoglobin A1c (HbA1c) in response to the dietary intervention | Blood will be drawn for the HbA1c | At screening, day 14, day 35, and day 49 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samuel Klein, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tara Wilmot | St Louis | Missouri | 63146 | United States |
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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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| Pea Fiber Bar | Other | Participants will be provided with a low fiber diet plus 1-3 daily pea fiber bars from days 15-35 |
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| Low fiber diet | Other | Participants will return to the low fiber diet for days 36-49- this phase is the same as phase 1. |
|