NCT01883401

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 21, 2013

Completed
Last Updated

June 21, 2013

Status Verified

June 1, 2013

Enrollment Period

2.9 years

First QC Date

May 13, 2013

Last Update Submit

June 19, 2013

Conditions

DyslipidemiaObesity

Keywords

StrawberriesHeart healthAnthocyanins

Outcome Measures

Primary Outcomes (1)

  • Lipids (mg/dL)

    Change in lipids and lipoproteins at screen and 12 weeks of the study

    2.5 years

Secondary Outcomes (1)

  • Adhesion molecules (ng/mL)

    2.5 years

Study Arms (4)

High dose strawberry

EXPERIMENTAL

50g freeze-dried strawberries/day

Dietary Supplement: Freeze-dried strawberries

Low-dose strawberry

EXPERIMENTAL

25g freeze-dried strawberries/day

Dietary Supplement: Freeze-dried strawberries

Fiber/calorie control (high dose)

OTHER

Dietary fiber (8g)

Dietary Supplement: Dietary fiber

Fiber/calorie control (low dose)

OTHER

Dietary fiber (4g)

Dietary Supplement: Dietary fiber

Interventions

Freeze-dried strawberriesDIETARY_SUPPLEMENT

25g or 50g freeze-dried strawberries reconstituted in water

High dose strawberryLow-dose strawberry
Dietary fiberDIETARY_SUPPLEMENT

4g or 8g dietary fiber blended in water

Fiber/calorie control (high dose)Fiber/calorie control (low dose)

Eligibility Criteria

Age19 Years - 72 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • on statin therapy
  • taking hypoglycemic agents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oklahoma State University

Stillwater, Oklahoma, 74078, United States

Location

Related Publications (2)

  • 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.

    PMID: 20797478BACKGROUND

  • 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.

    PMID: 24670970DERIVED

MeSH Terms

Conditions

DyslipidemiasObesity

Interventions

Dietary Fiber

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary CarbohydratesCarbohydratesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Arpita Basu, Phd

    Oklahoma State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 13, 2013

First Posted

June 21, 2013

Study Start

April 1, 2010

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

June 21, 2013

Record last verified: 2013-06

Locations

US(1)