The Effect of High and Low Roasted Coffee on Vascular Response

Cardiovascular Disease Clinical Trial

Official title:

The Effect of High and Low Roasted Coffee on Vascular Response

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01813981
• Other study ID #: COFF2011
• Status: Completed
• Phase: N/A
• First received: March 12, 2013
• Last updated: March 14, 2013
• Start date: May 2011
• Est. completion date: January 2013

Study information

• Verified date: March 2013
• Source: University of Reading
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: January 2013
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Dietary Supplement:
• Low roast coffee
Instant coffee
• High roast coffee
Instant coffee
• Control (Caffeine dissolved in water)
Caffeine dissolved in water

Locations

Country	Name	City	State
United Kingdom	Department of Food and Nutritional Sciences	Reading	Berkshire
United Kingdom	University of Reading	Reading	England

Sponsors (1)

Lead Sponsor	Collaborator
University of Reading

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vascular response measured by flow mediated dilatation (FMD)		Change from baseline to 2 hours	No