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

This study has been completed.
Sponsor:
Collaborators:
University of Oklahoma
California Strawberry Commission
Information provided by (Responsible Party):
Arpita Basu, Oklahoma State University
ClinicalTrials.gov Identifier:
NCT01883401
First received: May 13, 2013
Last updated: June 19, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Dyslipidemia
Obesity
Dietary Supplement: Freeze-dried strawberries
Dietary Supplement: Dietary fiber

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Chronic Effects of Freeze-dried Strawberry Beverage on Cardiovascular Risk Factors in Subjects With Abdominal Adiposity and Dyslipidemia.

Resource links provided by NLM:


Further study details as provided by Oklahoma State University:

Primary Outcome Measures:
  • Lipids (mg/dL) [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
    Change in lipids and lipoproteins at screen and 12 weeks of the study


Secondary Outcome Measures:
  • Adhesion molecules (ng/mL) [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
    Change in serum adhesion molecules (ICAM, VCAM) at screen and 12 weeks of the study.


Enrollment: 60
Study Start Date: April 2010
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High dose strawberry
50g freeze-dried strawberries/day
Dietary Supplement: Freeze-dried strawberries
25g or 50g freeze-dried strawberries reconstituted in water
Experimental: Low-dose strawberry
25g freeze-dried strawberries/day
Dietary Supplement: Freeze-dried strawberries
25g or 50g freeze-dried strawberries reconstituted in water
Fiber/calorie control (high dose)
Dietary fiber (8g)
Dietary Supplement: Dietary fiber
4g or 8g dietary fiber blended in water
Fiber/calorie control (low dose)
Dietary fiber (4g)
Dietary Supplement: Dietary fiber
4g or 8g dietary fiber blended in water

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.

  Eligibility

Ages Eligible for Study:   19 Years to 72 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • on statin therapy
  • taking hypoglycemic agents
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01883401

Locations
United States, Oklahoma
Oklahoma State University
Stillwater, Oklahoma, United States, 74078
Sponsors and Collaborators
Oklahoma State University
University of Oklahoma
California Strawberry Commission
Investigators
Principal Investigator: Arpita Basu, Phd Oklahoma State University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Arpita Basu, Assistant Professor, Oklahoma State University
ClinicalTrials.gov Identifier: NCT01883401     History of Changes
Other Study ID Numbers: HE1015
Study First Received: May 13, 2013
Last Updated: June 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Oklahoma State University:
Strawberries
Heart health
Anthocyanins

Additional relevant MeSH terms:
Obesity
Dyslipidemias
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 21, 2014