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This proposal seeks to build upon studies, including ours, on the favorable effects of California strawberries on vascular health. Freeze dried strawberry powder (FDSP) contains a number of nutrients that may have beneficial effects on plasma lipids and vascular function, as well as on the composition of the gut microbiota; changes in the gut microbiota can in turn have secondary positive effects on the vascular system as well as on other physiological functions that are important determinants of health and disease. The proposed project will seek to determine the influence of short-term FDSP intake on the gut microbiota composition, and select microbial-derived metabolites from stool, serum and urine, and their relationship to microvascular function. Secondary outcomes will include the influence of the FDSP on circulating levels of nitrate and nitrite and trimethylamine oxide (TMAO) as markers of vascular health that are influenced by both dietary intake and the oral and gut microflora, with blood pressure as an additional vascular outcome.
A randomized, double-blind, controlled crossover design will compare the short-term (two and four week) response to FDSP intake compared to an isocaloric control powder in overweight and obese adults. Twenty overweight or obese male or postmenopausal females (40-65 years of age) will be randomized to consume 39 g of FDSP or a control powder for four weeks in a crossover design with a four week washout period. Changes in stool microbial communities and microbial metabolites will be assessed, and examined for their potential influence on microvascular function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Powder | Placebo Comparator | Isocaloric powder |
|
| Freeze Dried Strawberry Powder | Experimental | Contains freeze dried strawberries |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Freeze Dried Strawberry Powder | Other | Study participants will be randomized to receive either the freeze dried strawberry powder or the control powder first. They will be instructed to consume 39g of the powder, mixed in water, every day for 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral Arterial Tonometry (PAT) | microvascular function testing | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Gut Microbiome | assessment of gut microbial populations | 10 weeks |
| Untargeted Metabolomics | assessment of primary metabolites | 10 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carl L Keen, PhD | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis; Department of Nutrition | Davis | California | 95616 | United States |
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| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D002318 | Cardiovascular Diseases |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Randomized, double-blind, controlled crossover dietary intervention trial
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The test powders where pre-packaged by the study sponsor and sent to the investigators coded.
| Isocaloric powder | Other | Isocaloric powder |
|
| Plasma Cholesterol | plasma cholesterol | 10 weeks |
| Plasma LDL | LDL | 10 weeks |
| Plasma HDL | HDL | 10 weeks |
| Nitrate | Circulating levels of Nitrate | 10 weeks |
| Nitrite | Circulating levels of Nitrite | 10 weeks |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |