Endothelial Dysfunction
Conditions
Brief summary
This study evaluates effects of different doses of phenolic acids on healthy volunteers.
Detailed description
It has been suggested that consumption of food rich in phenolic acids can help to improve vascular health, measured by flow mediated dilation (FMD).
Interventions
OTHER43.3 mg hydrolyzed green coffee extract
Reconstituted in water and given to subjects
OTHER86.6 mg hydrolyzed green coffee extract
Reconstituted in water and given to subjects
OTHER173 mg hydrolyzed green coffee extract
Reconstituted in water and given to subjects
OTHERPlacebo
Reconstituted in water and given to subjects
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or postmenopausal female healthy volunteers aged 45-65 years old * Willing and able to sign written informed consent prior to trial entry * Healthy as determined by the medical history and physical examination
Exclusion criteria
* Premenopausal women * Current smokers * Abnormal blood pressure as defined as follow: systolic \<90 or \>140 mmHg and diastolic \<60 or \>90 mmHg * Regular consumption of cholesterol-lowering medication * Regular consumption of antihypertensive medication * Regular consumption of any vasoactive medication that cannot be discontinued for at least 4 half-lives before the FMD assessment * Any food allergies * Any intakes of multivitamin-tablets and other supplemental compounds 10 days before the study start and throughout the study * Inability to refrain from coffee/tea and alcohol consumption for 12 h prior to study visits * Acute or chronic major psychiatric illness or other major illness that in the opinion of the investigator would make the subjects' participation in the study unsafe or prevent them from fully complying with the study procedures * Body mass index (BMI) outside 18-32 kg/m2 range
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy by oral administration of phenolic acid in improving endothelial function | 6 hours | Average change from baseline in %FMD at any time point post treatment. Responses will be calculated as the percentage change in brachial artery diameter from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC(Area Under Curve) of the concentration/time curve | 6 hours | link between endothelial function improvement in healthy subjects and plasma concentration of phenolic acids |
| Tmax | 6 hours | link between endothelial function improvement in healthy subjects and plasma concentration of phenolic acids |
| Elimination half-life | 6 hours | link between endothelial function improvement in healthy subjects and plasma concentration of phenolic acids |
Other
| Measure | Time frame | Description |
|---|---|---|
| Blood concentrations in plasma. | 6 hours | Blood concentrations in plasma. |
| To investigate safety of investigational products: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | through study completion, an average of 1 year. | Incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability\] |
Countries
Australia
Outcome results
None listed