NCT01813981

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2011

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 19, 2013

Completed
Last Updated

March 19, 2013

Status Verified

March 1, 2013

Enrollment Period

4 months

First QC Date

March 12, 2013

Last Update Submit

March 14, 2013

Conditions

Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

  • Vascular response measured by flow mediated dilatation (FMD)

    Change from baseline to 2 hours

Study Arms (3)

High roast coffee

PLACEBO COMPARATOR

110mg caffeine with 108 mg chlorogenic acid at start of study

Dietary Supplement: Control (Caffeine dissolved in water)

Low roast coffee

ACTIVE COMPARATOR

110 mg caffeine with 235 mg chlorogenic acid at start of the study

Dietary Supplement: Low roast coffee

Control

PLACEBO COMPARATOR

110 mg caffeine at start of study

Dietary Supplement: High roast coffee

Interventions

Low roast coffeeDIETARY_SUPPLEMENT

Instant coffee

Low roast coffee
High roast coffeeDIETARY_SUPPLEMENT

Instant coffee

Control
Control (Caffeine dissolved in water)DIETARY_SUPPLEMENT

Caffeine dissolved in water

High roast coffee

Eligibility Criteria

Age19 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male
  • A signed consent form
  • Age 19-35 years
  • Body mass index - 18.5-30 kg/m2
  • Normal blood pressure at screening (\< 150/90)

You may not qualify if:

  • 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)
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Food and Nutritional Sciences

Reading, Berkshire, RG6 6AP, United Kingdom

Location

University of Reading

Reading, England, RG6 6UR, United Kingdom

Location

Related Publications (1)

  • Mills CE, Flury A, Marmet C, Poquet L, Rimoldi SF, Sartori C, Rexhaj E, Brenner R, Allemann Y, Zimmermann D, Gibson GR, Mottram DS, Oruna-Concha MJ, Actis-Goretta L, Spencer JPE. Mediation of coffee-induced improvements in human vascular function by chlorogenic acids and its metabolites: Two randomized, controlled, crossover intervention trials. Clin Nutr. 2017 Dec;36(6):1520-1529. doi: 10.1016/j.clnu.2016.11.013. Epub 2016 Nov 30.

    PMID: 28012692DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Water

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Jeremy PE Spencer

    University of Reading

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 12, 2013

First Posted

March 19, 2013

Study Start

May 1, 2011

Primary Completion

September 1, 2011

Study Completion

January 1, 2013

Last Updated

March 19, 2013

Record last verified: 2013-03

Locations

GB(2)