- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01813981
The Effect of High and Low Roasted Coffee on Vascular Response
Evidence suggests that a diet rich in plant phenolic compounds may induce beneficial vascular effects. Coffee is a good source of phenolic compounds called chlorogenic acids (CGA), however the level of CGA is reduced during the roasting process.
The aim of this study is to investigate the effect of coffee roasting on vascular response. The investigators hypothesize that coffee roasted to a lesser extent will exert a favourable vascular response over more heavily roasted coffee due to the higher levels of CGA.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Berkshire
-
Reading, Berkshire, United Kingdom, RG6 6AP
- Department of Food and Nutritional Sciences
-
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England
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Reading, England, United Kingdom, RG6 6UR
- University of Reading
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male
- A signed consent form
- Age 19-35 years
- Body mass index - 18.5-30 kg/m2
- Normal blood pressure at screening (< 150/90)
Exclusion Criteria:
- Blood pressure > 150/90 mmHg
- Haemoglobin (anaemia marker) < 125 g/l
- Gamma GT (liver enzymes) > 80 IU/l
- Cholesterol > 6.5 mmol/l
- Had suffered a myocardial infarction or stroke in the previous 12 months
- Suffers from any reproductive disorder
- Suffers from any blood-clotting disorder
- Suffers from any metabolic disorders (e.g. diabetes or any other endocrine or liver diseases)
- Any dietary restrictions or on a weight reducing diet
- Drinking more than 21 units per week
- On any lipid-modifying medication
- On any blood pressure lowering medication
- On any medication affecting blood clotting
- Planning on altering consumption of vitamin supplements/fish oil capsules during the course of the study
- Regular or vigorous exercise (3 times/week, 20 minutes each session)
- Smoking
- Vegetarians or vegans
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: High roast coffee
110mg caffeine with 108 mg chlorogenic acid at start of study
|
Caffeine dissolved in water
|
|
Active Comparator: Low roast coffee
110 mg caffeine with 235 mg chlorogenic acid at start of the study
|
Instant coffee
|
|
Placebo Comparator: Control
110 mg caffeine at start of study
|
Instant coffee
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Vascular response measured by flow mediated dilatation (FMD)
Time Frame: Change from baseline to 2 hours
|
Change from baseline to 2 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jeremy PE Spencer, University of Reading
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- COFF2011
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