Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
34 participants
INTERVENTIONAL
2013-07-31
2014-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Influence of Freeze Dried Strawberry Consumption on Gut Microbiota and Cardiovascular Health.
NCT03283969
Strawberry Consumption in Overweight and Obese Individuals
NCT04094103
The Effect of Processed Tomato Products on CVD Risks
NCT00937742
Effect of a Spice Blend on Cardiovascular Risk Factors and Diet Satisfaction
NCT03064932
The Acute Effect of Spices on Vascular Health
NCT03064958
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
OTHER
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Strawberry Meal
40 g freeze-dried strawberries included in test meal
Strawberry Meal
High-fat meal (50 g total fat) with 40 g freeze dried strawberry powder
Control Meal
Control consisting of matched test meal with strawberry flavoring instead of freeze-dried strawberry powder
Control Meal
High-fat meal (50 g total fat) with a matched placebo powder containing no strawberry bioactives
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
20 Years
50 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
California Strawberry Commission
OTHER
Penn State University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Penny M Kris-Etherton, PhD
Role: PRINCIPAL_INVESTIGATOR
The Pennsylvania State University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Penn State University
University Park, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PKE STR
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.