NCT03599128

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

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
12 days until next milestone

Study Start

First participant enrolled

March 13, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2018

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

7 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 phenolic acid in improving endothelial function

    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.

    6 hours

Secondary Outcomes (3)

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

    6 hours

  • Tmax

    6 hours

  • Elimination half-life

    6 hours

Other Outcomes (2)

  • Blood concentrations in plasma.

    6 hours

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

    through study completion, an average of 1 year.

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

43.3 mg hydrolyzed green coffee extract

EXPERIMENTAL

hydrolyzed green coffee extract as interventions

Other: 43.3 mg hydrolyzed green coffee extract

86.6 mg hydrolyzed green coffee extract

EXPERIMENTAL

hydrolyzed green coffee extract as interventions

Other: 86.6 mg hydrolyzed green coffee extract

173 mg hydrolyzed green coffee extract

EXPERIMENTAL

hydrolyzed green coffee extract as interventions

Other: 173 mg hydrolyzed green coffee extract

Interventions

43.3 mg hydrolyzed green coffee extractOTHER

Reconstituted in water and given to subjects

Also known as: Phenolic acid
43.3 mg hydrolyzed green coffee extract
86.6 mg hydrolyzed green coffee extractOTHER

Reconstituted in water and given to subjects

Also known as: Phenolic acid
86.6 mg hydrolyzed green coffee extract
173 mg hydrolyzed green coffee extractOTHER

Reconstituted in water and given to subjects

Also known as: Phenolic acid
173 mg hydrolyzed green coffee extract
PlaceboOTHER

Reconstituted in water and given to subjects

Also known as: maltodextrin
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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Western Australia

Crawley, Perth, 6009, Australia

Location

MeSH Terms

Interventions

phenolic acidmaltodextrin

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

July 26, 2018

Study Start

March 13, 2018

Primary Completion

October 4, 2018

Study Completion

December 11, 2018

Last Updated

January 15, 2019

Record last verified: 2019-01

Locations

AU(1)