Clinical trial NCT01989637: Effect of Strawberries on Cardiovascular Disease Risk
Official title: Effects of a Freeze Dried Strawberry Powder on Postprandial Vascular Function and Blood Markers of Cardiovascular Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: California Strawberry Commission
First posted: 2013-11-21
Enrollment: 34
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: It is important to identify and evaluate foods, such as strawberries, that can improve established and emerging cardiovascular risk factors, such as postprandial lipid and glycemic responses, and vascular health. Postprandial derangements may affect multiple metabolic pathways that lead to increased arterial stiffness. Research has demonstrated the potential of strawberries to ameliorate postprandial responses to a high fat/high glucose meal. Further research is needed to demonstrate this effect in better controlled clinical studies and explore whether metabolic effects lead to improved arterial health.

The investigators propose to examine the effects of adding 40 g of freeze-dried strawberry powder to a high fat/high glucose meal on postprandial cardiovascular risk factor including lipids, insulin, glucose, and arterial stiffness and central blood pressure. The investigators hypothesize that the bioactive components of strawberry powder will attenuate postprandial lipemic and glycemic responses, as well as improve measures of arterial health.


Eligibility criteria: Inclusion Criteria:

* 20-50 years of age
* LDL-C below 160 mg/dL
* Triglycerides below 350 mg/dL
* No stage II hypertension (BP below 160/100 mmHg)
* Not taking medication for elevated lipids, blood pressure, or glucose

Exclusion Criteria:

* Allergies to strawberries
* Known intolerance to high fat meals
* History of cardiovascular disease, kidney disease, diabetes or inflammatory diseases such as GI disorders and arthritis
* Use of non-steroidal anti-inflammatory or immunosuppressant drugs
* Conditions requiring the use of steroids
* Use of medication or supplements for elevated lipids, blood pressure or glucose

Primary outcomes:
measure: Change from baseline in postprandial central blood pressure and arterial stiffness
timeFrame: 2 and 4 hours
Secondary outcomes:
measure: Postprandial changes in insulin
timeFrame: 0, 0.5, 1, 2, and 4 hours
measure: Postprandial changes in glucose
timeFrame: 0, 0.5, 1, 2, and 4 hours
measure: Postprandial changes in markers of inflammation/oxidative stress
timeFrame: 0, 0.5, 1, 2, and 4 hours
measure: Change from baseline in postprandial triglycerides at 0.5, 1, 2, and 4 hours
timeFrame: 0.5, 1, 2, and 4 hours
Other outcomes:
Locations:
city: University Park
country: United States
facility: Penn State University
state: Pennsylvania
Study officials:
affiliation: The Pennsylvania State University
name: Penny M Kris-Etherton, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Zunino SJ, Parelman MA, Freytag TL, Stephensen CB, Kelley DS, Mackey BE, Woodhouse LR, Bonnel EL. Effects of dietary strawberry powder on blood lipids and inflammatory markers in obese human subjects. Br J Nutr. 2012 Sep;108(5):900-9. doi: 10.1017/S0007114511006027. Epub 2011 Nov 9.
citation: Skulas-Ray AC, Kris-Etherton PM, Teeter DL, Chen CY, Vanden Heuvel JP, West SG. A high antioxidant spice blend attenuates postprandial insulin and triglyceride responses and increases some plasma measures of antioxidant activity in healthy, overweight men. J Nutr. 2011 Aug;141(8):1451-7. doi: 10.3945/jn.111.138966. Epub 2011 Jun 22.
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citation: Richter CK, Skulas-Ray AC, Gaugler TL, Lambert JD, Proctor DN, Kris-Etherton PM. Incorporating freeze-dried strawberry powder into a high-fat meal does not alter postprandial vascular function or blood markers of cardiovascular disease risk: a randomized controlled trial. Am J Clin Nutr. 2017 Feb;105(2):313-322. doi: 10.3945/ajcn.116.141804. Epub 2016 Dec 21.