Coffee-bioavailability-cardiovascular health

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Bioavailability of antioxidants in coffee and effect of their acute and chronic consumption in cardiovascular health

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

Colcafé (Colcafé) Universidad de Antioquia (Colombia) Universidad CES (Colombia)

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Gloria

Midle name:

María

Last name:

Agudelo Ochoa

Medical Specialty :

Dietist, Magister in Clinical Nutrition

Affiliation:

Vidarium, research center on nutrition health and wellness

Postal address:

Calle 8 Sur 50-67

City:

Medellin

País:

Colombia

Zip Code:

05001000

Telephone:

+57-42856600 ext. 4503

+57-42856600 ext. 4507

Email address:

gmagudelo@serviciosnutresa.com [1]

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Colombia

Clinical sites:

Not applicable

Research ethics committees:

State Antioquia, City Medellín, Research ethic committee of Universidad CES, 16th May 2012

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

03/09/2012

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Oxidative stress, inflammation, endothelial function, blood pressure and lipid profile

Intervention(s):

Group 1 (control): not coffee consumption Group 2 (Study): coffee consumption of two cups of coffee A per day, each cup of 200 mL (oral administration), during 8 weeks Group 3 (Study): coffee consumption of two cups of coffee B per day, each cup of 200 mL (oral administration), during 8 weeks

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Plasma levels of caffeic acid and ferulic acid (quantitative determination in nmol/L by chromatography). Measurement time: at baseline, 1 hour after the first consumption, 8 weeks after the inclusion. Total antioxidant capacity (umol-equ-TROLOX/L plasma values measured by FRAP and TRAP methods). Measurement time: at baseline, 1 hour after the first consumption, 8 weeks after the inclusion. Delay in LDL oxidation ((lipid peroxidation), LDL oxidation Lag time in seconds). Measurement time: at baseline, 8 weeks after the inclusion.

Key secondary outcomes:

Isoprostanes levels (in ng/mg creatinine by chromatography). Measurement time: at baseline, 8 weeks after the inclusion. High Sensitive C-reactive protein ((Hs-CRP). Guidelines according to AHA/CDC (<0.1 low cardiovascular risk; 0.1-0.3 average cardiovascular risk; 0.3-1.0 high cardiovascular risk; >1.0 persistent elevations may represent non-cardiovascular inflammation)). Measurement time: at baseline, 8 weeks after the inclusion. Fibrinogen (measured in mg% by nephelometry). Measurement time: at baseline, 8 weeks after the inclusion. Total cholesterol (Colorimetric assay (mg/dL)). Measurement time: at baseline,8 weeks after the inclusion. cLDL, (enzymatic assay (mg/dL)). Measurement time: at baseline, 8 weeks after the inclusion. cHDL (enzymatic assay (mg/dL)). Measurement time: at baseline, 8 weeks after the inclusion. Triglycerides (Colorimetric assay (mg/dL)). Measurement time: at baseline, 8 weeks after the inclusion. Endothelial function (Flow mediated dilation test of brachial artery (% of change)). Measurement time: at baseline, 8 weeks after the inclusion. Nitric oxide metabolites (Colorimetric kit (uM)). Measurement time: at baseline, 8 weeks after the inclusion. Blood pressure (Standardized technique according to AHA and European Association of Cardiology (mmHg)). Measurement time: at baseline, 8 weeks after the inclusion.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

60 years

Inclusion criteria:

1. Aged ≥ 18 and ≤ 60 years 2. Body mass index (BMI) between 18.8 kg/m2 and 30 kg/m2 up. 3. Habitual coffee drinkers: consumption in the last year of three or more cups / day. 4. No smokers. 5. No highly competitive sportspeople (subjects with a sedentary physical activity, mild or moderate will be included, in no case exceeding 10 hours per week of training). 6. No history and / or diagnosis of chronic diseases (heart attack, hypertension, congestive heart failure, stroke, arrhythmia, dyslipidemia, diabetes mellitus, cancer, chronic renal failure, hepatic dysfunction, hypothyroidism, insomnia, duodenal ulcer, gastritis, malabsorption syndrome, dysautonomia, sleep disturbances and psychiatric disorders). 7. No consumption of drugs: Hypolipidemic agent, antioxidant supplements, anticonvulsants, anti-inflammatories, steroids, psychiatric drugs, hormone replacement therapy. 8. With a maximum of 10 alcohol drinks per week for women and 15 for men. 9. Having a work schedule between 7.00 am and 6.00 pm Monday to Friday and not have to leave the institution during the study.

Exclusion criteria:

1. Women who are pregnant or breastfeeding. 2. Vegetarians. 3. Subjects with secondary symptoms to coffee consumption.

Type of population:

Adults

Type of participant:

Healthy volunteers

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Other

Other purpose:

Assess the bioavailability of the phenolic compounds provided by two types of filtered coffee with different concentrations of chlorogenic acids and the effect of their acute and chronic consumption on markers of oxidative stress, inflammation, endothelial function and blood pressure in a group of apparently healthy adults.

Allocation:

Randomized controlled trial

Masking:

Single Blind

Control group:

No intervention

Study design:

Parallel

Phase:

N/A

Target sample size:

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Gloria

Middle Name:

María

Last Name:

Agudelo Ochoa

Specialty:

Dietist, Magister in Clinical Nutrition

Affiliation:

Vidarium, centro de investigación en nutrición, salud y bienestar. Grupo Empresarial Nutresa

Postal Address:

Calle 8 Sur 50-67

City:

Medellin

País:

Colombia

Zip Code:

05001000

Telephone:

(+574) 2856600 ext 4503

Email :

gmagudelo@serviciosnutresa.com [1]

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Katalina

Last Name:

Muñoz Durango

Specialty:

Pharmaceutical Chemist, Ph.D Chemical Sciences

Affiliation:

Vidarium, centro de investigación en nutrición, salud y bienestar. Grupo Empresarial Nutresa

Postal Address:

Calle 8 Sur 50-67

City:

Medellin

País:

Colombia

Zip Code:

05001000

Telephone:

(+574)2856600 ext 4504

Email :

kmunoz@serviciosnutresa.com [2]

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Unique ID number:

RPCEC00000168

Date of Registration in Primary Registry:

13/09/2013

Record Verification Date:

2013/09/13

Next update date:

2014/09/13

Link to the spanish version:

Click here [3]