Effect of Strawberries on Cardiovascular Disease Risk

NCT01989637 | Completed

• 1 other identifier: PKE STR
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• Change from baseline in postprandial central blood pressure and arterial stiffness

  2 and 4 hours

Secondary Outcomes (4)

• Postprandial changes in insulin

  0, 0.5, 1, 2, and 4 hours

• Postprandial changes in glucose

  0, 0.5, 1, 2, and 4 hours

• Postprandial changes in markers of inflammation/oxidative stress

  0, 0.5, 1, 2, and 4 hours

• Change from baseline in postprandial triglycerides at 0.5, 1, 2, and 4 hours

  0.5, 1, 2, and 4 hours

Study Arms (2)

Strawberry Meal

EXPERIMENTAL

40 g freeze-dried strawberries included in test meal

Dietary Supplement: Strawberry Meal

Control Meal

PLACEBO COMPARATOR

Control consisting of matched test meal with strawberry flavoring instead of freeze-dried strawberry powder

Dietary Supplement: Control Meal

Interventions

Strawberry Meal DIETARY_SUPPLEMENT

High-fat meal (50 g total fat) with 40 g freeze dried strawberry powder

Strawberry Meal

Control Meal DIETARY_SUPPLEMENT

High-fat meal (50 g total fat) with a matched placebo powder containing no strawberry bioactives

Control Meal

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Penn State University: lead
• California Strawberry Commission: collaborator

Study Sites (1)

Penn State University

University Park, Pennsylvania, 16801, United States

Location

Related Publications (11)

• 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.

  PMID: 15705218 BACKGROUND

• 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.

  PMID: 22914551 BACKGROUND

• 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.

  PMID: 18258621 BACKGROUND

• 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: 20797478 BACKGROUND

• 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.

  PMID: 19785767 BACKGROUND

• 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.

  PMID: 20595645 BACKGROUND

• 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.

  PMID: 19013285 BACKGROUND

• 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.

  PMID: 22068016 BACKGROUND

• 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.

  PMID: 21697300 BACKGROUND

• 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.

  PMID: 21412692 BACKGROUND

• 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.

  PMID: 28003205 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Penny M Kris-Etherton, PhD

  The Pennsylvania State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2013
• First Posted: November 21, 2013
• Study Start: July 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: June 1, 2014
• Last Updated: August 21, 2023

Record last verified: 2023-08

Locations

US (1)