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OpenTrials
Completed

NCT Number: NCT03599128

Effect of Phenolic Acids on the Human Vasculature

This study evaluates effects of different doses of phenolic acids on healthy volunteers.

Completed

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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 phenolic acids can help to improve vascular health, measured by flow mediated dilation (FMD).

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 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

Treatment and study plan

43.3 mg hydrolyzed green coffee extract

Other

Reconstituted in water and given to subjects

Other names: Phenolic acid

86.6 mg hydrolyzed green coffee extract

Other

Reconstituted in water and given to subjects

Other names: Phenolic acid

173 mg hydrolyzed green coffee extract

Other

Reconstituted in water and given to subjects

Other names: Phenolic acid

Placebo

Other

Reconstituted in water and given to subjects

Other names: maltodextrin

Primary outcomes

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

    Time frame: 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 outcomes

  1. AUC(Area Under Curve) of the concentration/time curve

    Time frame: 6 hours

    link between endothelial function improvement in healthy subjects and plasma concentration of phenolic acids

  2. Tmax

    Time frame: 6 hours

    link between endothelial function improvement in healthy subjects and plasma concentration of phenolic acids

  3. Elimination half-life

    Time frame: 6 hours

    link between endothelial function improvement in healthy subjects and plasma concentration of phenolic acids

Other outcomes

  1. Blood concentrations in plasma.

    Time frame: 6 hours

    Blood concentrations in plasma.

  2. To investigate safety of investigational products: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Time frame: through study completion, an average of 1 year.

    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
Jul 26, 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.

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