Clinical trial NCT03520452: Effect of Chlorogenic Acids on the Human Vasculature
Official title: Effect of Chlorogenic Acids on the Human Vasculature
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endothelial Dysfunction
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2018-05-09
Enrollment: 22
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Efficacy by oral administration of chlorogenic acid in improving endothelial function
timeFrame: 24 hours
Secondary outcomes:
measure: Cmax of the different chlorogenic acid metabolites
timeFrame: 24 hours
measure: Area Under Curve of the concentration/time curve
timeFrame: 24 hours
measure: Tmax
timeFrame: 24 hours
measure: elimination half-life.
timeFrame: 24 hours
Other outcomes:
measure: Blood concentrations in plasma.
timeFrame: 24 hours
measure: Safety of the investigational product
timeFrame: from first dose till last visit
Locations:
city: Crawley
country: Australia
facility: University of Western Australia
state: Perth
Study officials:
affiliation: Société des Produits Nestlé (SPN)
name: Leslie Tan
role: STUDY_CHAIR
References:
citation: Naylor LH, Zimmermann D, Guitard-Uldry M, Poquet L, Leveques A, Eriksen B, Bel Rhlid R, Galaffu N, D'Urzo C, De Castro A, Van Schaick E, Green DJ, Actis-Goretta L. Acute dose-response effect of coffee-derived chlorogenic acids on the human vasculature in healthy volunteers: a randomized controlled trial. Am J Clin Nutr. 2021 Feb 2;113(2):370-379. doi: 10.1093/ajcn/nqaa312.