Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000467932
Ethics application status
Approved
Date submitted
4/05/2011
Date registered
5/05/2011
Date last updated
31/01/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Acute effects of chlorogenic acid on endothelial function, blood pressure and nitric oxide (NO) status in healthy men and women
Scientific title
Acute effects of chlorogenic acid on endothelial function, blood pressure and nitric oxide (NO) status in healthy men and women
Secondary ID [1] 260101 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 258704 0
Condition category
Condition code
Cardiovascular 258857 258857 0 0
Coronary heart disease
Diet and Nutrition 258858 258858 0 0
Other diet and nutrition disorders
Cardiovascular 258859 258859 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomised, controlled cross-over design trial will be conducted to investigate the acute effects of chlorogenic acid on metabolism of nitrogen oxides,as well as blood pressure and endothelial function.

Each participant will complete 2 visits (one treatment at each visit) one week apart in random order. The two treatments are:
1. No chlorogenic acid
2. Chlorogenic acid
Prior to each visit participants will be asked to consume a standard low flavonoid meal for breakfast.

Participants will then attend the School of Medicine and Pharmacology Research Unit at Royal Perth Hospital where they will be provided with 400 mg chlorogenic acid in 200 ml water.
Intervention code [1] 257661 0
Treatment: Other
Intervention code [2] 264530 0
Prevention
Comparator / control treatment
No chlorogenic acid
Control group
Active

Outcomes
Primary outcome [1] 259716 0
Nitric oxide status assessed by measuring plasma S-nitrosothiols using a NO analyser
Timepoint [1] 259716 0
Baseline and 2 hours after treatment
Secondary outcome [1] 266438 0
Endothelial function assessed by measuring flow mediated dilatation of the brachial artery using ultrasound
Timepoint [1] 266438 0
Baseline and 90 min after treatment
Secondary outcome [2] 266439 0
Blood pressure measured using an automated blood pressure monitor
Timepoint [2] 266439 0
Baseline and 60,90,120 and 150 min after treatment

Eligibility
Key inclusion criteria
Men and women aged 18 to 65 years
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Current or recent (<12 months) smoking
2. Body mass index < 18 or > 35 kg/m2,
3. History of cardiovascular or peripheral vascular disease,
4. A systolic blood pressure below 100 or above 160 mmHg
5. A diastolic blood pressure below 50 or above 100 mmHg
6. Diagnosed diabetes, and non-diabetic individuals with 7.Fasting plasma glucose concentrations greater than or equal to 5.5 mmol/L,
8. A psychiatric illness,
9. Other major illnesses such as cancer,
10. Current or recent (within previous 6 months) significant 11. Weight loss or gain (> 6% of body weight),
12. Reported lactating, pregnant or wishing to become pregnant during the study,
13. Alcohol intake > 210 g per wk for women and > 280 g per wk for men, and
14. Inability or unwillingness to consume foods/beverages provided.
15. Unwillingness to stop the use of supplements 24 hours prior to the testing day.
16. Have any health conditions that would affect food metabolism including the following: food allergies, kidney disease, liver disease and/or gastrointestinal diseases (e.g Irritable bowel syndrome, celiac disease, peptic ulcers)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The treatment order for eligible individuals will be randomly assigned using computer generated random numbers. The treatment order allocation will be sealed in numbered envelopes. The envelopes will be used for randomisation by opening an envelope, in consecutive order, as participants are entered in the study. The envelopes will be held by an independent person within the University of Western Australia. The study coordinator will contact the independent person to obtain the next available envelope once an individual is deemed eligible. The envelope will be opened and the code will be recorded.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random numbers using Microsoft Excel
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/12/2010
Actual
8/12/2010
Date of last participant enrolment
Anticipated
Actual
6/06/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258135 0
Government body
Name [1] 258135 0
NHMRC
Country [1] 258135 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
The University of Western Australia, 35 Stirling Highway, Crawley, WA 6009
Country
Australia
Secondary sponsor category [1] 257305 0
None
Name [1] 257305 0
Address [1] 257305 0
Country [1] 257305 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260114 0
University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 260114 0
The University of Western Australia, 35 Stirling Highway, Crawley, WA 6009
Ethics committee country [1] 260114 0
Australia
Date submitted for ethics approval [1] 260114 0
Approval date [1] 260114 0
11/02/2009
Ethics approval number [1] 260114 0
RA/4/1/2276

Summary
Brief summary
The primary objective of this study is to investigate if chlorogenic acid will increase circulating nitric oxide and if these effects are associated vascular benefits.
Trial website
Trial related presentations / publications
Bondonno CP*, Mubarak A*, Liu AH, Considine MJ, Rich L, Mas E, Croft KD, Hodgson JM. Acute effects of chlorogenic acid on nitric oxide status, endothelial function and blood pressure in healthy volunteers: a randomised trial. Journal of Agricultural and Food Chemistry. 2012; 60(36), 9130-9136
Public notes

Contacts
Principal investigator
Name 31950 0
Prof Jonathan Hodgson
Address 31950 0
University of Western Australia
GPO Box X2213 Perth WA 6847
Country 31950 0
Australia
Phone 31950 0
+61 8 9224 0267
Fax 31950 0
Email 31950 0
[email protected]
Contact person for public queries
Name 15197 0
Dr Catherine Bondonno
Address 15197 0
University of Western Australia
GPO Box X2213 Perth WA 6847
Country 15197 0
Australia
Phone 15197 0
+61 8 9224 0342
Fax 15197 0
Email 15197 0
[email protected]
Contact person for scientific queries
Name 6125 0
Dr Catherine Bondonno
Address 6125 0
University of Western Australia
GPO Box X2213 Perth WA 6847
Country 6125 0
Australia
Phone 6125 0
+61 8 9224 0342
Fax 6125 0
Email 6125 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.