Effect of Strawberries on Cardiovascular Disease Risk

Not Applicable

Completed

• Conditions: Cardiovascular Disease
• Interventions: Dietary Supplement: Strawberry Meal; Dietary Supplement: Control Meal

• Registration Number: NCT01989637
• Lead Sponsor: Penn State University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-31
• Study First Submitted QC: 2013-11-20
• Study First Posted: 2013-11-21
• Primary Completion: 2014-03
• Study Completion: 2014-06
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-16
• Last Update Posted: 2023-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Strawberry Meal	Strawberry Meal	40 g freeze-dried strawberries included in test meal
Control Meal	Control Meal	Control consisting of matched test meal with strawberry flavoring instead of freeze-dried strawberry powder

Primary Outcome Measures

Name	Time	Method
Change from baseline in postprandial central blood pressure and arterial stiffness	2 and 4 hours

Secondary Outcome Measures

Name	Time	Method
Postprandial changes in glucose	0, 0.5, 1, 2, and 4 hours
Postprandial changes in insulin	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

Trial Locations

Locations (1)

Penn State University; 🇺🇸 University Park, Pennsylvania, United States