Skip to main content
OpenTrials
Completed

NCT Number: NCT03520452

Effect of Chlorogenic Acids on the Human Vasculature

This study evaluates effects of different doses of chlorogenic acids on vascular health.

Completed

Looking for future studies?

Notify Me

Key information

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Western Australia

Crawley, Perth, 6009, Australia

About this study

It has been suggested that consumption of food rich in chlorogenic acids can help to improve vascular health, measured by flow mediated dilation.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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, 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 within 10 days of 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
  • Use of medication to treat psychiatric illness (depression) within 3 months prior to the study
  • Recent significant weight loss or gain (>6% of body weight) in the past 3 months
  • Body mass index (BMI) outside 18-32 kg/m2 range
  • Alcohol intake > 280g/week (21-28 glasses per week)

Treatment and study plan

Green coffee extract

Other

Reconstituted in water and given to subjects

Placebo

Other

Placebo

Primary outcomes

  1. Efficacy by oral administration of chlorogenic acid in improving endothelial function

    Time frame: 24 hours

    The primary outcome will be the average change from baseline (i.e. predose) in the %Flow Mediated Dilation

Secondary outcomes

  1. Cmax of the different chlorogenic acid metabolites

    Time frame: 24 hours

    link for endothelial function improvement

  2. Area Under Curve of the concentration/time curve

    Time frame: 24 hours

    Area Under Curve of the concentration/time curve

  3. Tmax

    Time frame: 24 hours

    link for endothelial function improvement

  4. elimination half-life.

    Time frame: 24 hours

    link for endothelial function improvement

Other outcomes

  1. Blood concentrations in plasma.

    Time frame: 24 hours

    Blood concentrations in plasma.

  2. Safety of the investigational product

    Time frame: from first dose till last visit

    Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 9, 2018
Registry last updated
Jan 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.