NCT03520452

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

March 14, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 9, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2018

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

8 months

First QC Date

March 1, 2018

Last Update Submit

January 14, 2019

Conditions

Endothelial Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Efficacy by oral administration of chlorogenic acid in improving endothelial function

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

    24 hours

Secondary Outcomes (4)

  • Cmax of the different chlorogenic acid metabolites

    24 hours

  • Area Under Curve of the concentration/time curve

    24 hours

  • Tmax

    24 hours

  • elimination half-life.

    24 hours

Other Outcomes (2)

  • Blood concentrations in plasma.

    24 hours

  • Safety of the investigational product

    from first dose till last visit

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

302 mg green coffee extract

EXPERIMENTAL

Green coffee extract

Other: Green coffee extract

604 mg green coffee extract

EXPERIMENTAL

Green coffee extract

Other: Green coffee extract

906 mg green coffee extract

EXPERIMENTAL

Green coffee extract

Other: Green coffee extract

Interventions

Green coffee extractOTHER

Reconstituted in water and given to subjects

302 mg green coffee extract604 mg green coffee extract906 mg green coffee extract
PlaceboOTHER

Placebo

Placebo

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Western Australia

Crawley, Perth, 6009, Australia

Location

Related Publications (1)

  • 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.

    PMID: 33330899DERIVED

Study Officials

  • Leslie Tan

    Société des Produits Nestlé (SPN)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2018

First Posted

May 9, 2018

Study Start

March 14, 2018

Primary Completion

November 7, 2018

Study Completion

December 20, 2018

Last Updated

January 15, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)