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| Name | Class |
|---|---|
| California Strawberry Commission | OTHER |
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Our proposal represents an integrated approach to determining the cardiovascular and metabolic effects of strawberry consumption in adults who have high risk for cardiometabolic disease.
The current proposal aims to fill some of these important research gaps with regard the dose and time-course of strawberry consumption in a population where dietary intervention may of particular benefit for both primary and secondary prevention of cardiovascular and metabolic disease. Participants will participate in a double blind, placebo-controlled, randomized crossover trial. Following a 10-day run-in where no berries are consumed, participants will be randomized via Latin-square design, to three different daily strawberry powder conditions for 4-weeks at a time, with a 7 day washout between conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active strawberry powder | Experimental | Participants will consume a 39g freeze-dried active strawberry powder beverage once per day for 4-weeks. |
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| Placebo strawberry powder | Placebo Comparator | Participants will consume a 39g freeze-dried strawberry powder placebo beverage once per day for 4-weeks. |
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| Mixed active/placebo strawberry powder | Active Comparator | Participants will consume a 39g mixed active/placebo strawberry powder beverage once per day for 4-weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active strawberry powder | Dietary Supplement | Participants will drink a strawberry beverage with active ingredients once a day during the 4-week intervention period. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in plasma lipids | Total cholesterol (TC), LDL-c , VLDL-c, HDL-c , triglycerides (TG) from blood sample in a fasted state and following consumption of a meal | Week 0, 4, 5, 9, 10, and 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in glucose and insulin response | Glucose, insulin, and c-peptide obtained from blood sample in a fasted state and in response to a meal | Week 0, 4, 5, 9, 10, and 14 |
| Change in oxidixed LDL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sara Rosenkranz, PhD | Kansas State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lafene Health Center | Manhattan | Kansas | 66502 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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The supplement and placebo will be distributed to the individual by a member of the research team who is not involved with data collection or analysis.
| Placebo strawberry powder | Dietary Supplement | Participants will drink a strawberry placebo beverage once a day during the 4-week intervention period. |
|
| Mixed strawberry powder | Dietary Supplement | Participants will drink a mixed strawberry beverage with active ingredients and placebo once a day during the 4-week intervention period. |
|
Obtained from blood sample in a fasted state and following consumption of a meal
| Week 0, 4, 5, 9, 10, and 14 |
| Change in homeostatic model assessment for insulin resistance | Calculated from fasting glucose and insulin values | Week 0, 4, 5, 9, 10, and 14 |
| Change in inflammation | hs-CRP and IL-6 will be assessed in the fasted state from plasma | Week 0, 4, 5, 9, 10, and 14 |
| Change in arterial stiffness | Determined via changes in carotid artery stiffness calculated from simultaneous measurements of carotid artery diameter and pressure-waveforms | Week 0, 4, 5, 9, 10, and 14 |
| Change in blood pressure (resting and 24-hr) | Evaluated via automated sphygmomanometer. 24-hr ambulatory blood pressure is taken at 20-30 minute intervals over a 24hr period while the individual goes about their normal activities and while sleeping. | Week 0, 4, 5, 9, 10, and 14 |
| Change in endothelial function | Flow mediated dilation (FMD) assessed via a non-invasive 2D Doppler ultrasound following a 5-min period of arterial occlusion. | Week 0, 4, 5, 9, 10, and 14 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |