The Effect of High and Low Roasted Coffee on Vascular Response

NCT ID: NCT01813981

Last Updated: 2013-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2013-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiovascular Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

High roast coffee

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

Group Type PLACEBO_COMPARATOR

Control (Caffeine dissolved in water)

Intervention Type DIETARY_SUPPLEMENT

Caffeine dissolved in water

Low roast coffee

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

Group Type ACTIVE_COMPARATOR

Low roast coffee

Intervention Type DIETARY_SUPPLEMENT

Instant coffee

Control

110 mg caffeine at start of study

Group Type PLACEBO_COMPARATOR

High roast coffee

Intervention Type DIETARY_SUPPLEMENT

Instant coffee

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Low roast coffee

Instant coffee

Intervention Type DIETARY_SUPPLEMENT

High roast coffee

Instant coffee

Intervention Type DIETARY_SUPPLEMENT

Control (Caffeine dissolved in water)

Caffeine dissolved in water

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

19 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Reading

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jeremy Paul Edward Spencer

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jeremy PE Spencer

Role: PRINCIPAL_INVESTIGATOR

University of Reading

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Food and Nutritional Sciences

Reading, Berkshire, United Kingdom

Site Status

University of Reading

Reading, England, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 28012692 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

COFF2011

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Interindividual Variation in Response to Green Coffee
NCT06204445 ACTIVE_NOT_RECRUITING NA