Endothelial Dysfunction
Conditions
Brief summary
The objective is to demonstrate the effect of phenolic acids on endothelial function.
Interventions
DIETARY_SUPPLEMENTphenolic acid
phenolic acid
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
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 * Smokers * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from predose in percent change of flow-mediated dilatation at 1h compared to control treatment | After 1 hour |
Secondary
| Measure | Time frame |
|---|---|
| Change from predose in blood pressure at 0.5h | After 30 min |
Countries
Australia
Outcome results
None listed