Endothelial Dysfunction
Conditions
Brief summary
This study evaluates effects of different doses of chlorogenic acids on vascular health.
Detailed description
It has been suggested that consumption of food rich in chlorogenic acids can help to improve vascular health, measured by flow mediated dilation.
Interventions
OTHERGreen coffee extract
Reconstituted in water and given to subjects
OTHERPlacebo
Placebo
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
1. Male or postmenopausal female healthy volunteers aged 45-65 years old 2. Willing and able to sign written informed consent prior to trial entry 3. Healthy as determined by the medical history and physical examination
Exclusion criteria
1. Premenopausal women 2. Current smokers 3. Abnormal blood pressure, defined as follow: systolic \<90 or \>140 mmHg and diastolic \<60 or \>90 mmHg 4. Regular consumption of cholesterol-lowering medication 5. Regular consumption of antihypertensive medication 6. Regular consumption of any vasoactive medication that cannot be discontinued for at least 4 half-lives before the FMD assessment 7. Any food allergies 8. Any intakes of multivitamin-tablets and other supplemental compounds within 10 days of the study start and throughout the study 9. Inability to refrain from coffee/tea and alcohol consumption for 12 h prior to study visits 10. 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 11. Use of medication to treat psychiatric illness (depression) within 3 months prior to the study 12. Recent significant weight loss or gain (\>6% of body weight) in the past 3 months 13. Body mass index (BMI) outside 18-32 kg/m2 range 14. Alcohol intake \> 280g/week (21-28 glasses per week)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy by oral administration of chlorogenic acid in improving endothelial function | 24 hours | The primary outcome will be the average change from baseline (i.e. predose) in the %Flow Mediated Dilation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax of the different chlorogenic acid metabolites | 24 hours | link for endothelial function improvement |
| Area Under Curve of the concentration/time curve | 24 hours | Area Under Curve of the concentration/time curve |
| Tmax | 24 hours | link for endothelial function improvement |
| elimination half-life. | 24 hours | link for endothelial function improvement |
Other
| Measure | Time frame | Description |
|---|---|---|
| Blood concentrations in plasma. | 24 hours | Blood concentrations in plasma. |
| Safety of the investigational product | from first dose till last visit | Incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability\] |
Countries
Australia
Outcome results
None listed