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| Name | Class |
|---|---|
| University of Oklahoma | OTHER |
| California Strawberry Commission | OTHER |
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Berry anthocyanins have been shown to improve lipid profile in subjects with dyslipidemia while no such studies with whole strawberries have been reported in the US population. The investigators propose to examine the effects of low and high doses of freeze-dried strawberries on serum glucose, insulin, and lipid profile, biomarkers of oxidative stress and inflammation, in a 12-week randomized controlled trial. Subjects with abdominal adiposity and dyslipidemia (n=15/group) will be recruited at OUHSC and OSU, and randomly assigned to the low (25g/day) or high (50g/day) strawberry dose, or matched control (fiber and calories) group. The strawberry group will consume freeze-dried strawberry beverage (2 cups/day) and the controls will consume 2 cups beverage (fiber +calories) daily for 12 weeks. Blood draws, anthropometrics, blood pressure, and dietary data will be collected at screen, 6 and 12 weeks of the study to determine chronic and acute effects of strawberry intervention. Serum or plasma samples will be analyzed for fasting glucose, insulin, lipid profile including total cholesterol, LDL-, and HDL-cholesterol, triglycerides, lipid particle size, and levels of oxidative stress (malondialdehyde, oxidized LDL, myeloperoxidase), inflammation (high sensitivity C-reactive protein, adiponectin, interleukins) and adhesion molecules. Repeated measures ANOVA will be performed using a 5% significance level. We anticipate a dose response effect in decrease in lipids, oxidative stress or inflammation following strawberry intervention versus controls.
The overall objective of this clinical trial is to investigate the effects of low and high doses of freeze-dried strawberries in cardiovascular risk factors in subjects with abdominal adiposity and dyslipidemia versus age and gender-matched controls.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose strawberry | Experimental | 50g freeze-dried strawberries/day |
|
| Low-dose strawberry | Experimental | 25g freeze-dried strawberries/day |
|
| Fiber/calorie control (high dose) | Other | Dietary fiber (8g) |
|
| Fiber/calorie control (low dose) | Other | Dietary fiber (4g) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Freeze-dried strawberries | Dietary Supplement | 25g or 50g freeze-dried strawberries reconstituted in water |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lipids (mg/dL) | Change in lipids and lipoproteins at screen and 12 weeks of the study | 2.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Adhesion molecules (ng/mL) | Change in serum adhesion molecules (ICAM, VCAM) at screen and 12 weeks of the study. | 2.5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arpita Basu, Phd | Oklahoma State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oklahoma State University | Stillwater | Oklahoma | 74078 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20797478 | Background | Basu A, Fu DX, Wilkinson M, Simmons B, Wu M, Betts NM, Du M, Lyons TJ. Strawberries decrease atherosclerotic markers in subjects with metabolic syndrome. Nutr Res. 2010 Jul;30(7):462-9. doi: 10.1016/j.nutres.2010.06.016. | |
| 24670970 | Derived | Basu A, Betts NM, Nguyen A, Newman ED, Fu D, Lyons TJ. Freeze-dried strawberries lower serum cholesterol and lipid peroxidation in adults with abdominal adiposity and elevated serum lipids. J Nutr. 2014 Jun;144(6):830-7. doi: 10.3945/jn.113.188169. Epub 2014 Mar 26. |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D050177 | Overweight |
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| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| ID | Term |
|---|---|
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
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| Dietary fiber | Dietary Supplement | 4g or 8g dietary fiber blended in water |
|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010829 |
| Physiological Phenomena |
| D019602 | Food and Beverages |