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The Effect of High and Low Roasted Coffee on Vascular Response

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ClinicalTrials.gov Identifier: NCT01813981
Recruitment Status : Completed
First Posted : March 19, 2013
Last Update Posted : March 19, 2013
Sponsor:
Information provided by (Responsible Party):
Jeremy Paul Edward Spencer, University of Reading

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Cardiovascular Disease Dietary Supplement: Low roast coffee Dietary Supplement: High roast coffee Dietary Supplement: Control (Caffeine dissolved in water) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: The Effect of High and Low Roasted Coffee on Vascular Response
Study Start Date : May 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : January 2013

Arm Intervention/treatment
Placebo Comparator: High roast coffee
110mg caffeine with 108 mg chlorogenic acid at start of study
Dietary Supplement: Control (Caffeine dissolved in water)
Caffeine dissolved in water

Active Comparator: Low roast coffee
110 mg caffeine with 235 mg chlorogenic acid at start of the study
Dietary Supplement: Low roast coffee
Instant coffee

Placebo Comparator: Control
110 mg caffeine at start of study
Dietary Supplement: High roast coffee
Instant coffee




Primary Outcome Measures :
  1. Vascular response measured by flow mediated dilatation (FMD) [ Time Frame: Change from baseline to 2 hours ]


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Ages Eligible for Study:   19 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01813981


Locations
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United Kingdom
Department of Food and Nutritional Sciences
Reading, Berkshire, United Kingdom, RG6 6AP
University of Reading
Reading, England, United Kingdom, RG6 6UR
Sponsors and Collaborators
University of Reading
Investigators
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Principal Investigator: Jeremy PE Spencer University of Reading

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jeremy Paul Edward Spencer, Professor, University of Reading
ClinicalTrials.gov Identifier: NCT01813981     History of Changes
Other Study ID Numbers: COFF2011
First Posted: March 19, 2013    Key Record Dates
Last Update Posted: March 19, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
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Cardiovascular Diseases
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents