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Cardiovascular DiseaseNCT01989637

Effect of Strawberries on Cardiovascular Disease Risk

A study testing Strawberry Meal in people with Cardiovascular Disease, run by Penn State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Cardiovascular Disease
What is being tested?
Strawberry Meal
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
34 participants
Where
1 siteUnited States
Study dates
Jul 2013to Jun 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Penn State University

    University Park, Pennsylvania, 16801

Other trials in United States

About this study

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

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.

Being tested
Strawberry Meal, Control Meal
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Strawberry MealDietary supplement

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

  • Control MealDietary supplement

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

Study groups in NCT01989637
Study groupRoleWhat they receive
Strawberry MealExperimental40 g freeze-dried strawberries included in test meal
Receives: Dietary Supplement: Strawberry Meal
Control MealPlacebo comparatorControl consisting of matched test meal with strawberry flavoring instead of freeze-dried strawberry powder
Receives: Dietary Supplement: Control Meal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in postprandial central blood pressure and arterial stiffness

    Measured: 2 and 4 hours

Secondary outcomes (4)

  1. Postprandial changes in insulin

    Measured: 0, 0.5, 1, 2, and 4 hours

  2. Postprandial changes in glucose

    Measured: 0, 0.5, 1, 2, and 4 hours

  3. Postprandial changes in markers of inflammation/oxidative stress

    Measured: 0, 0.5, 1, 2, and 4 hours

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

    Measured: 0.5, 1, 2, and 4 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionMar 2014
  4. Study completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01989637
Sponsor's protocol ID
PKE STR
Status last verified
Aug 2023
First submitted
31 Jul 2013
Last updated
21 Aug 2023
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 15705218

  • 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.

    PubMed 22914551

  • 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.

    PubMed 18258621

  • 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.

    PubMed 20797478

  • 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.

    PubMed 19785767

  • 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.

    PubMed 20595645

  • 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.

    PubMed 19013285

  • 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.

    PubMed 22068016

  • 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.

    PubMed 21697300

  • 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.

    PubMed 21412692

  • 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.

    PubMed 28003205

Questions about this trial

What is this clinical trial studying?

A study testing Strawberry Meal in people with Cardiovascular Disease, run by Penn State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in postprandial central blood pressure and arterial stiffness (time frame: 2 and 4 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01989637, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.

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