Effects of Freeze Dried Strawberry Powder Supplementation on Vascular Function and Blood Markers of Cardiovascular Risk

Cardiovascular Disease Clinical Trial

Official title:

Effects of Freeze Dried Strawberry Powder Supplementation on Vascular Function and Blood Markers of Cardiovascular Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02557334
• Other study ID #: PKE STRAW II
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: May 2019

Study information

• Verified date: August 2023
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Dietary Supplement:
• Low Dose Strawberry Powder
40 g composed of 13 g freeze dried strawberry powder + 27 g placebo powder
• High Dose Strawberry Powder
40 g freeze dried strawberry powder
• Placebo Powder
40 g color and taste matched placebo powder

Locations

Country	Name	City	State
United States	Penn State CRC	University Park	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Penn State University	California Strawberry Commission

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL-C	LDL-C values calculated using the Friedewald equation	Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage
Secondary	Central Blood Pressure	Aortic (central) blood pressure measured using the SphygmoCor System	Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage
Secondary	Peripheral Blood Pressure	Peripheral blood pressure measured using the SphygmoCor System	Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage
Secondary	Augmentation Index	Augmentation index measured using the SphygmoCor System	Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage
Secondary	Pulse Wave Velocity	Pulse wave velocity measured using the SphygmoCor System	Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage
Secondary	Total Cholesterol	Total cholesterol values determined by enzymatic procedures	Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage
Secondary	Triglycerides	Triglyceride values determined using enzymatic procedures	Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage
Secondary	HDL-C	HDL-C will be estimated according to the modified heparin-manganese procedure	Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage
Secondary	Oxidized LDL (oxLDL)	Plasma concentrations of oxLDL will be measured using ELISA kits	Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage
Secondary	Malondialdehyde (MDA)	MDA will be measured using the thiobarbituric acid reactive substances (TBARS) assay	Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage
Secondary	High Sensitivity C Reactive Protein (hs-CRP)	hs-CRP will be measured by latex-enhanced immunonephelometry	Change from baseline after 4 week treatments of low dose, high dose, and placebo strawberry beverage