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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA253219 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The study investigators will recruit a generally healthy sample of 112 black and white adults from Birmingham, AL to participate in a 28-day randomized, controlled feeding study. Participants will be randomized to receive either the DASH diet or a standard American diet. All meals will be provided by the study. Fecal samples will be collected at multiple time points before, during, and after the dietary intervention and will be analyzed using PCR to amplify the V4 region of the 16S rRNA gene and to sequence bases using the MiSeq platform. Sequenced data will then be analyzed using QIIME. The investigators hypothesize that participants receiving the DASH diet will have a greater increase in alpha diversity and greater changes in abundances of CRC-associated microbes than participants receiving the standard American diet. The investigators will also evaluate functional-level markers including bile acid and short chain fatty acid (SCFA) production and inflammatory markers. If the investigator's hypothesis is supported, they expect to see reduced production of secondary bile acids (e.g., deoxycholic acid), greater SCFA production (e.g, butyrate), and reduction in gut and systemic inflammation (e.g, calprotectin, IL-6) among participants receiving the DASH diet compared to the standard American diet. The investigator's findings will provide preliminary evidence for the DASH diet as an approach for cultivating a healthier gut microbiota across racially diverse populations. These findings can impact clinical, translational, and population-level approaches for modification of the gut microbiota to reduce risk of chronic diseases like CRC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DASH Diet | Experimental | calorie-restricted DASH diet (25% fat; 57% carbohydrate; 18% protein; 34 g fiber) |
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| standard American diet | Active Comparator | calorie-restricted standard American diet (35% fat; 51% carbohydrate; %15 protein; 14 g fiber) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DASH Diet | Behavioral | Participant will receive foods following the DASH dietary pattern for 28 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean change in alpha diversity | The investigators will assess the difference in alpha diversity determined by analyzing fecal samples. | baseline - day 28 |
| Mean change in alpha diversity | The investigators will assess the difference in alpha diversity determined by analyzing fecal samples. | day 28 - day 42 |
| Diet specific changes in secondary bile acids | The investigators will calculate changes in cholic acid in milligrams | baseline - day 28 |
| Diet specific changes in secondary bile acids | The investigators will calculate changes in cholic acid in milligrams | day 28 - day 42 |
| Diet-specific changes in inflammatory marker | The investigators will calculate changes in interleukin-6 in pg/L | baseline - day 28 |
| Diet-specific changes in inflammatory marker | The investigators will calculate changes in interleukin-6 in pg/L | day 28 - day 42 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tiffany L Carson, PhD | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36265810 | Derived | Carson TL, Buro AW, Miller D, Pena A, Ard JD, Lampe JW, Yi N, Lefkowitz E, William VP, Morrow C, Wilson L, Barnes S, Demark-Wahnefried W. Rationale and study protocol for a randomized controlled feeding study to determine the structural- and functional-level effects of diet-specific interventions on the gut microbiota of non-Hispanic black and white adults. Contemp Clin Trials. 2022 Dec;123:106968. doi: 10.1016/j.cct.2022.106968. Epub 2022 Oct 18. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000073601 | Dietary Approaches To Stop Hypertension |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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| standard American diet | Behavioral | Participants will receive foods following the standard American diet for 28 days. |
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| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |