NCT01781559CompletedNot Applicable
Effect of Phenolic Acids on the Human Vasculature
Société des Produits Nestlé (SPN)2 sites in 1 country14 target enrollmentStarted: October 1, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 14
- Locations
- 2
- Primary Endpoint
- Change from predose in percent change of flow-mediated dilatation at 1h compared to control treatment
Study Overview
Brief Summary
The objective is to demonstrate the effect of phenolic acids on endothelial function.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy, Men and women
- •Subjects with endothelial dysfunction defined as a basal brachial artery flow-mediated dilatation (FMD) measurement between 3% and 8% at screening
Exclusion Criteria
- •Any food allergy
- •Abnormal blood pressure defined as follow: systolic <100 or >160 mmHg and diastolic <50 or >100mmHg
- •Pregnancy or lactating women
- •Regular consumption of cholesterol-lowering or antihypertensive medication
- •Inability to restrain from caffeine/tea and alcohol for 12hrs prior to study visits (intake1 day before screening measurements (and 1 day before each visit)
- •Not restrain the intake of multivitamin-tablets and other supplemental compounds 10 days before the study start and throughout the study.
- •Excessive alcohol intake defined as > 280 g per week for men and >210g per week for women
Outcomes
Primary Outcomes
Change from predose in percent change of flow-mediated dilatation at 1h compared to control treatment
Time Frame: After 1 hour
Secondary Outcomes
- Change from predose in blood pressure at 0.5h(After 30 min)
Investigators
Study Sites (2)
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