Effects of Acute Red Raspberry Consumption on Vascular Function in Healthy Individuals

Study Overview
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Brief Summary
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Accumulating evidence from epidemiological and human intervention studies indicates that the cardiovascular health benefits of diets rich in fruits and vegetables are (in part) related to their (poly)phenol content. Raspberries are rich in phenolic and polyphenolic compounds, in particular procyanidins, ellagitannins and anthocyanins, but also phenolic acids. At present, a small number of randomized controlled trials investigating the effects of berry (poly)phenols on validated surrogate markers of cardiovascular disease risk have shown promising results. However, to date, very few human studies have specifically investigated the effects of raspberry (poly)phenols on cardiovascular function in healthy subjects. Moreover, ellagitannin-derived metabolites are believed to persist for a long period of time in the blood and urine. Therefore, the investigators will investigate the presence of plasma and urinary raspberry-derived metabolites 24h post-consumption. To the investigators knowledge, the effects of red raspberry consumption on vascular function in humans have not been investigated before. This information is necessary for the planning of long-term studies aiming to assess the potential beneficial effects of raspberries,. Therefore, this study aims to investigate the potential role of red raspberry (poly)phenols in the modulation of vascular function by monitoring changes in vascular function together with the major (poly)phenol derivatives/metabolites in plasma.

Official Title
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Effects of Acute Red Raspberry Consumption on Vascular Function in Healthy Individuals

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: 400 g frozen raspberries
* Dietary Supplement: 200 g frozen raspberries
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy male subjects (no clinical signs or symptoms of cardiovascular disease) Exclusion Criteria: Cardiovascular disease acute inflammation cardiac arrhythmia renal failure heart failure (NYHA II-IV) diabetes mellitus C - reactive protein > 05 mg/dL malignant disease raspberry allergy/intolerance hypotension (≤100 / 60 mm Hg)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 400 g frozen raspberries<br>Red raspberry beverage Acute intake of 600 mL (1x daily) | Dietary Supplement: 400 g frozen raspberries<br>* 1x daily intake of 600 mL red raspberry beverage<br>|
| Active Comparator: 200 g frozen raspberries<br>Red raspberry beverage Acute intake of 600 mL (1x daily) | Dietary Supplement: 200 g frozen raspberries<br>* 1x daily intake of 600 mL red raspberry beverage<br>|
| Placebo Comparator: Placebo control<br>Raspberry deprived supplement Acute intake of 600 mL (1x daily) | Dietary Supplement: Placebo<br>* 1x daily intake of 600 mL raspberry deprived supplement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to 2 hour and 24 hour in Endothelial function | measured by flow mediated dilation (FMD) on baseline at 2 and 24 hour postconsumption | Baseline, 2 hour and 24 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to 2 hour and 24 hour in Pulse wave velocity | measured by sphygmomanometer SphygmoCor on baseline at 2 and 24 hours postconsumption | Baseline, 2 hour and 24 hour | 
| Change from baseline to 2 hour and 24 hour in Central blood pressure | measured by sphygmomanometer SphygmoCor on baseline at 2 and 24 hours postconsumption | Baseline, 2 hour and 24 hour | 
| Peripheral blood pressure | measured by automatic sphygmomanometer on baseline at 2 and 24 hours postconsumption | Baseline, 2 h and 24 h | 
| Change from baseline to 2 hour and 24 hour in Heart rate | measured by SphygmoCor on baseline at 2 and 24 hours postconsumption | Baseline, 2 hour and 24 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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polyphenols, vascular function, endothelial function, raspberry