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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03520452




Registration number
NCT03520452
Ethics application status
Date submitted
1/03/2018
Date registered
9/05/2018

Titles & IDs
Public title
Effect of Chlorogenic Acids on the Human Vasculature
Scientific title
Effect of Chlorogenic Acids on the Human Vasculature
Secondary ID [1] 0 0
1716NRC
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endothelial Dysfunction 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Green coffee extract
Other interventions - Placebo

Placebo comparator: Placebo - Placebo

Experimental: 302 mg green coffee extract - Green coffee extract

Experimental: 604 mg green coffee extract - Green coffee extract

Experimental: 906 mg green coffee extract - Green coffee extract


Other interventions: Green coffee extract
Reconstituted in water and given to subjects

Other interventions: Placebo
Placebo
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Efficacy by oral administration of chlorogenic acid in improving endothelial function
Timepoint [1] 0 0
24 hours
Secondary outcome [1] 0 0
Cmax of the different chlorogenic acid metabolites
Timepoint [1] 0 0
24 hours
Secondary outcome [2] 0 0
Area Under Curve of the concentration/time curve
Timepoint [2] 0 0
24 hours
Secondary outcome [3] 0 0
Tmax
Timepoint [3] 0 0
24 hours
Secondary outcome [4] 0 0
elimination half-life.
Timepoint [4] 0 0
24 hours

Eligibility
Key inclusion criteria
1. Male or postmenopausal female healthy volunteers aged 45-65 years old
2. Willing and able to sign written informed consent prior to trial entry
3. Healthy as determined by the medical history and physical examination
Minimum age
45 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Premenopausal women
2. Current smokers
3. Abnormal blood pressure, defined as follow: systolic <90 or >140 mmHg and diastolic <60 or >90 mmHg
4. Regular consumption of cholesterol-lowering medication
5. Regular consumption of antihypertensive medication
6. Regular consumption of any vasoactive medication that cannot be discontinued for at least 4 half-lives before the FMD assessment
7. Any food allergies
8. Any intakes of multivitamin-tablets and other supplemental compounds within 10 days of the study start and throughout the study
9. Inability to refrain from coffee/tea and alcohol consumption for 12 h prior to study visits
10. 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
11. Use of medication to treat psychiatric illness (depression) within 3 months prior to the study
12. Recent significant weight loss or gain (>6% of body weight) in the past 3 months
13. Body mass index (BMI) outside 18-32 kg/m2 range
14. Alcohol intake > 280g/week (21-28 glasses per week)

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/03/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/12/2018
Sample size
Target
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)
Pert
Recruitment hospital [1] 0 0
University of Western Australia - Crawley
Recruitment postcode(s) [1] 0 0
6009 - Crawley

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Société des Produits Nestlé (SPN)
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Leslie Tan
Address 0 0
Société des Produits Nestlé (SPN)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03520452