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Effect of Phenolic Acids on the Human Vasculature

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03599128
Recruitment Status : Completed
First Posted : July 25, 2018
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Nestlé

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

Condition or disease Intervention/treatment Phase
Endothelial Dysfunction Other: 43.3 mg hydrolyzed green coffee extract Other: 86.6 mg hydrolyzed green coffee extract Other: 173 mg hydrolyzed green coffee extract Other: Placebo Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Effect of Phenolic Acids on the Human Vasculature
Actual Study Start Date : March 13, 2018
Actual Primary Completion Date : October 4, 2018
Actual Study Completion Date : December 11, 2018

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo
Other: Placebo
Reconstituted in water and given to subjects
Other Name: maltodextrin

Experimental: 43.3 mg hydrolyzed green coffee extract
hydrolyzed green coffee extract as interventions
Other: 43.3 mg hydrolyzed green coffee extract
Reconstituted in water and given to subjects
Other Name: Phenolic acid

Experimental: 86.6 mg hydrolyzed green coffee extract
hydrolyzed green coffee extract as interventions
Other: 86.6 mg hydrolyzed green coffee extract
Reconstituted in water and given to subjects
Other Name: Phenolic acid

Experimental: 173 mg hydrolyzed green coffee extract
hydrolyzed green coffee extract as interventions
Other: 173 mg hydrolyzed green coffee extract
Reconstituted in water and given to subjects
Other Name: Phenolic acid




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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]



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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03599128


Locations
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Australia, Perth
University of Western Australia
Crawley, Perth, Australia, 6009
Sponsors and Collaborators
Nestlé
Investigators
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Study Chair: Leslie Tan Nestlé

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Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT03599128     History of Changes
Other Study ID Numbers: 1717NRC
First Posted: July 25, 2018    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No