Effects of Freeze Dried Strawberry Powder Supplementation on Vascular Function and Blood Markers of Cardiovascular Risk
| Status: | Recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 35 - 65 |
| Updated: | 3/24/2019 |
| Start Date: | October 2015 |
| End Date: | December 2019 |
| Contact: | Danette Teeter, BS |
| Phone: | 814-863-8622 |
The purpose of this study is to evaluate the effects of freeze dried strawberry powder on LDL
cholesterol, central and peripheral blood pressure, indices of arterial stiffness, and other
lipid and lipoprotein concentrations. The investigators hypothesize that the bioactive
compounds in freeze dried strawberry powder may elicit beneficial effects on LDL cholesterol,
as well as blood pressure and arterial health.
cholesterol, central and peripheral blood pressure, indices of arterial stiffness, and other
lipid and lipoprotein concentrations. The investigators hypothesize that the bioactive
compounds in freeze dried strawberry powder may elicit beneficial effects on LDL cholesterol,
as well as blood pressure and arterial health.
The proposed study design is a 3-period randomized crossover dose-response study to evaluate
the effect of freeze dried strawberry powder supplementation on LDL-C and vascular health.
Research participants will be overweight or obese (BMI 25-39 kg/m^2) but otherwise healthy
adults with moderately elevated LDL-C (>116 mg/dL or >3.0mmol/L), blood pressure <160/100
mmHg, total cholesterol below 273 mg/dL for men and below 284 mg/dL for women, and
triglycerides below 350 mg/dL. Subjects will be randomly assigned to three supplementation
periods: 1) low dose freeze dried strawberry powder (13 g/d); 2) high dose freeze dried
strawberry powder (40 g/d); and 3) a placebo powder. Each powder will be provided for 4-6
weeks, separated by a 2-week washout period between treatment periods. Baseline and endpoint
testing will include blood collection and vascular testing.
the effect of freeze dried strawberry powder supplementation on LDL-C and vascular health.
Research participants will be overweight or obese (BMI 25-39 kg/m^2) but otherwise healthy
adults with moderately elevated LDL-C (>116 mg/dL or >3.0mmol/L), blood pressure <160/100
mmHg, total cholesterol below 273 mg/dL for men and below 284 mg/dL for women, and
triglycerides below 350 mg/dL. Subjects will be randomly assigned to three supplementation
periods: 1) low dose freeze dried strawberry powder (13 g/d); 2) high dose freeze dried
strawberry powder (40 g/d); and 3) a placebo powder. Each powder will be provided for 4-6
weeks, separated by a 2-week washout period between treatment periods. Baseline and endpoint
testing will include blood collection and vascular testing.
Inclusion Criteria:
1. Men and women 35-65 years of age
2. BMI ≥ 25 and ≤ 39 kg/m^2
3. LDL-C > 116 mg/dL
4. Total Cholesterol below 273 mg/dL for men and below 284 mg/dL for women
5. Triglycerides below 350 mg/d
6. Non-smokers
7. Blood pressure < 160/100 mmHg
Exclusion Criteria:
1. History of acute or chronic inflammatory conditions or heart disease, kidney disease,
liver disease, autoimmune disorders, or thyroid disease (unless controlled by
medication and blood results within the previous 6 months are provided)
2. History of diabetes mellitus (and/or a fasting glucose > 126 mg/dL at screening)
3. Stage II hypertension (blood pressure ≥ 160/100 mmHg)
4. Lactation, pregnancy, or desire to become pregnant during the study
5. Unwillingness to discontinue nutritional supplements, herbs, or vitamins, unless
approved by investigator
6. Use of medications/supplements for elevated lipids, blood pressure, or glucose
7. Chronic use of non-steroidal anti-inflammatory or immunosuppressant medication
8. Conditions requiring the use of steroids
9. Unwillingness to refrain from blood donation prior to and during the study
10. Any medical condition or abnormal laboratory value that is judged clinically
significant by an investigator
11. Allergy or sensitivity to strawberries or any ingredient in the study powders
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