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Chronic Effects of Freeze-Dried Strawberry Beverage on Cardiovascular Risk Factors

Primary Purpose

Dyslipidemia, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Freeze-dried strawberries
Dietary fiber
Sponsored by
Oklahoma State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemia focused on measuring Strawberries, Heart health, Anthocyanins

Eligibility Criteria

19 Years - 72 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • dyslipidemia
  • abdominal adiposity (>35 inches for women, >40 inches for men)

Exclusion Criteria:

  • on statin therapy
  • taking hypoglycemic agents

Sites / Locations

  • Oklahoma State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Other

Other

Arm Label

High dose strawberry

Low-dose strawberry

Fiber/calorie control (high dose)

Fiber/calorie control (low dose)

Arm Description

50g freeze-dried strawberries/day

25g freeze-dried strawberries/day

Dietary fiber (8g)

Dietary fiber (4g)

Outcomes

Primary Outcome Measures

Lipids (mg/dL)
Change in lipids and lipoproteins at screen and 12 weeks of the study

Secondary Outcome Measures

Adhesion molecules (ng/mL)
Change in serum adhesion molecules (ICAM, VCAM) at screen and 12 weeks of the study.

Full Information

First Posted
May 13, 2013
Last Updated
June 19, 2013
Sponsor
Oklahoma State University
Collaborators
University of Oklahoma, California Strawberry Commission
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1. Study Identification

Unique Protocol Identification Number
NCT01883401
Brief Title
Chronic Effects of Freeze-Dried Strawberry Beverage on Cardiovascular Risk Factors
Official Title
Chronic Effects of Freeze-dried Strawberry Beverage on Cardiovascular Risk Factors in Subjects With Abdominal Adiposity and Dyslipidemia.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oklahoma State University
Collaborators
University of Oklahoma, California Strawberry Commission

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia, Obesity
Keywords
Strawberries, Heart health, Anthocyanins

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High dose strawberry
Arm Type
Experimental
Arm Description
50g freeze-dried strawberries/day
Arm Title
Low-dose strawberry
Arm Type
Experimental
Arm Description
25g freeze-dried strawberries/day
Arm Title
Fiber/calorie control (high dose)
Arm Type
Other
Arm Description
Dietary fiber (8g)
Arm Title
Fiber/calorie control (low dose)
Arm Type
Other
Arm Description
Dietary fiber (4g)
Intervention Type
Dietary Supplement
Intervention Name(s)
Freeze-dried strawberries
Intervention Description
25g or 50g freeze-dried strawberries reconstituted in water
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary fiber
Intervention Description
4g or 8g dietary fiber blended in water
Primary Outcome Measure Information:
Title
Lipids (mg/dL)
Description
Change in lipids and lipoproteins at screen and 12 weeks of the study
Time Frame
2.5 years
Secondary Outcome Measure Information:
Title
Adhesion molecules (ng/mL)
Description
Change in serum adhesion molecules (ICAM, VCAM) at screen and 12 weeks of the study.
Time Frame
2.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: dyslipidemia abdominal adiposity (>35 inches for women, >40 inches for men) Exclusion Criteria: on statin therapy taking hypoglycemic agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arpita Basu, Phd
Organizational Affiliation
Oklahoma State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oklahoma State University
City
Stillwater
State/Province
Oklahoma
ZIP/Postal Code
74078
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20797478
Citation
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.
Results Reference
background
PubMed Identifier
24670970
Citation
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.
Results Reference
derived

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Chronic Effects of Freeze-Dried Strawberry Beverage on Cardiovascular Risk Factors

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