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OpenTrials
Completed

NCT Number: NCT01989637

Effect of Strawberries on Cardiovascular Disease 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.

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State University

University Park, Pennsylvania, 16801, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Strawberry Meal

Dietary Supplement

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

Control meal

Dietary Supplement

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

Primary outcomes

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

    Time frame: 2 and 4 hours

Secondary outcomes

  1. Postprandial changes in insulin

    Time frame: 0, 0.5, 1, 2, and 4 hours

  2. Postprandial changes in glucose

    Time frame: 0, 0.5, 1, 2, and 4 hours

  3. Postprandial changes in markers of inflammation/oxidative stress

    Time frame: 0, 0.5, 1, 2, and 4 hours

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

    Time frame: 0.5, 1, 2, and 4 hours

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • California Strawberry Commission

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 21, 2013
Registry last updated
Aug 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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