Effect of Strawberries on Cardiovascular Disease Risk

Cardiovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01989637
• Other study ID #: PKE STR
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Est. completion date: June 2014

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Dietary Supplement:
• Strawberry Meal
High-fat meal (50 g total fat) with 40 g freeze dried strawberry powder
• Control Meal
High-fat meal (50 g total fat) with a matched placebo powder containing no strawberry bioactives

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Penn State University	California Strawberry Commission

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

Basu A, Wilkinson M, Penugonda K, Simmons B, Betts NM, Lyons TJ. Freeze-dried strawberry powder improves lipid profile and lipid peroxidation in women with metabolic syndrome: baseline and post intervention effects. Nutr J. 2009 Sep 28;8:43. doi: 10.1186/1475-2891-8-43. — View Citation

Burdge GC, Calder PC. Plasma cytokine response during the postprandial period: a potential causal process in vascular disease? Br J Nutr. 2005 Jan;93(1):3-9. doi: 10.1079/bjn20041282. — View Citation

Burton-Freeman B, Linares A, Hyson D, Kappagoda T. Strawberry modulates LDL oxidation and postprandial lipemia in response to high-fat meal in overweight hyperlipidemic men and women. J Am Coll Nutr. 2010 Feb;29(1):46-54. doi: 10.1080/07315724.2010.10719816. — View Citation

de la Garza AL, Milagro FI, Boque N, Campion J, Martinez JA. Natural inhibitors of pancreatic lipase as new players in obesity treatment. Planta Med. 2011 May;77(8):773-85. doi: 10.1055/s-0030-1270924. Epub 2011 Mar 16. — View Citation

Erlund I, Koli R, Alfthan G, Marniemi J, Puukka P, Mustonen P, Mattila P, Jula A. Favorable effects of berry consumption on platelet function, blood pressure, and HDL cholesterol. Am J Clin Nutr. 2008 Feb;87(2):323-31. doi: 10.1093/ajcn/87.2.323. — View Citation

Jenkins DJ, Nguyen TH, Kendall CW, Faulkner DA, Bashyam B, Kim IJ, Ireland C, Patel D, Vidgen E, Josse AR, Sesso HD, Burton-Freeman B, Josse RG, Leiter LA, Singer W. The effect of strawberries in a cholesterol-lowering dietary portfolio. Metabolism. 2008 Dec;57(12):1636-44. doi: 10.1016/j.metabol.2008.07.018. — View Citation

Jennings A, Welch AA, Fairweather-Tait SJ, Kay C, Minihane AM, Chowienczyk P, Jiang B, Cecelja M, Spector T, Macgregor A, Cassidy A. Higher anthocyanin intake is associated with lower arterial stiffness and central blood pressure in women. Am J Clin Nutr. 2012 Oct;96(4):781-8. doi: 10.3945/ajcn.112.042036. Epub 2012 Aug 22. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in postprandial central blood pressure and arterial stiffness		2 and 4 hours
Secondary	Postprandial changes in insulin		0, 0.5, 1, 2, and 4 hours
Secondary	Postprandial changes in glucose		0, 0.5, 1, 2, and 4 hours
Secondary	Postprandial changes in markers of inflammation/oxidative stress		0, 0.5, 1, 2, and 4 hours
Secondary	Change from baseline in postprandial triglycerides at 0.5, 1, 2, and 4 hours		0.5, 1, 2, and 4 hours