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The investigators will conduct a 2-arm randomized controlled pilot, feasibility feeding study in which 28 participants will be randomized to receive either a calorie-restricted Dietary Approaches to Stop Hypertension (DASH) diet or a calorie-restricted standard American diet provided by the study for 4 weeks. Participants will be non-Hispanic black or white, generally healthy females (14 black, 14 white). The investigators will collect fecal samples at multiple time points before, during, and after the dietary intervention to analyze for changes in the gut microbiota and functional-level metabolic products. This work will be led by an interdisciplinary team including expertise in bio-behavioral science, microbiology, nutrition science, bioinformatics, and biostatistics all with cross-cutting expertise in health disparities, prevention research, nutrition, the gut microbiota, inflammation and other biomarkers. The rationale for the proposed research is that once the interactions between race, diet, and the gut microbiota are more fully understood, targeted diet modifications may provide new and innovative approaches for the prevention and treatment of obesity and obesity-related diseases.
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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 |
|
| standard American diet | Active Comparator | calorie-restricted standard American diet (35% fat; 51% carbohydrate; %15 protein; 14 g fiber |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DASH diet | Behavioral | brief description |
| |
| standard American diet |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Weight Change of Participants | Weight change as measured by a scale in kilograms at multiple time points will be calculated and averaged. | Baseline to day 28 |
| Mean Weight Change of Participants | Weight change as measured by a scale in kilograms at multiple time points will be calculated and averaged. | Day 28 to Day 42 |
| Mean Weight Change of Participants | Weight change as measured by a scale in kilograms at multiple time points will be calculated and averaged. | Baseline to day 42 |
| Diet-specific changes in secondary bile acid | The investigators will calculate changes in cholic acid in milligrams. | Baseline to day 28 |
| Diet-specific changes in secondary bile acid | The investigators will calculate changes in cholic acid in milligrams. | day 28 to day 42 |
| Diet-specific changes in secondary bile acid | The investigators will calculate changes in cholic acid in milligrams. | baseline to day 42 |
| Diet-specific changes in inflammatory marker | The investigators will calculate changes in c-reactive protein in mg/L. | baseline to day 28 |
| Diet-specific changes in inflammatory marker |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tiffany L Carson, PhD | Contact | 813-745-4944 | Tiffany.Carson@moffitt.org |
| Name | Affiliation | Role |
|---|---|---|
| Tiffany L Carson, PhD | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffit Cancer Center | Tampa | Florida | 33612 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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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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| Behavioral |
describe |
|
The investigators will calculate changes in c-reactive protein in mg/L. |
| day 28 to day 42 |
| Diet-specific changes in inflammatory marker | The investigators will calculate changes in c-reactive protein in mg/L. | baseline to day 42 |
| Diet-specific changes in short chain fatty acids | The investigators will calculate changes in acetic acid in mmol/L | baseline to day 28 |
| Diet-specific changes in short chain fatty acids | The investigators will calculate changes in acetic acid in mmol/L | day 28 to day 42 |
| Diet-specific changes in short chain fatty acids | The investigators will calculate changes in acetic acid in mmol/L | baseline to day 42 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |