Bioavailability and Beneficial Properties of Coffee and Cocoa Bioactive Compounds

NCT03166540 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2017-10-25

No results posted yet for this study

Summary

The aim of this study will be to define the bioavailability and the beneficial properties of coffee bioactive compounds. Moreover, the contribution of cocoa-based products containing coffee to the pool of circulating metabolites will be investigated with the aim of evaluating the effect of the combination of bioactives from different sources.

To study the bioavailability of coffee/cocoa bioactive compounds and their effects in cardiometabolic health, the objectives will be:

i) Assessing the bioavailability of the four main groups of phytochemicals in roasted coffee (methylxanthines, phenolic compounds, trigonelline, and diterpenes), its modulation by the level of consumption, and establishing the daily average concentration of coffee-derived plasma circulating metabolites; ii) Investigating the effect of different levels of coffee consumption on cardiometabolic risk factors; iii) Evaluating circulating metabolites and their putative bioactivity when substituting coffee consumption with the intake of cocoa-based products containing coffee.

A 3-arm, crossover, randomized trial will be conducted. Twenty-one volunteers will be randomly assigned to consume three treatments in a random order for 1 month: 1 cup of espresso coffee/day, 3 cups of espresso coffee/day, 1 cup of espresso coffee at breakfast and 2 cocoa-based products containing coffee two times per day. The last day of the treatment subjects will refer to the ambulatory where blood and urine samples will be collected at specific time points up to 24 hours following the consumption of the testing coffee or of the cocoa-based products containing coffee. In addition to the bioavailability of the bioactive compounds, the effect of the coffee consumption on several cardiometabolic risk factors (blood pressure, anthropometric measures, inflammatory markers, nitric oxide, blood lipids, fasting indices of glucose/insulin metabolism, DNA damage, eicosanoids, nutri-metabolomics) will be investigated. At the end of the treatment, the same protocol will be repeated, switching the allocation group.

Conditions

  • Diet Modification
  • Cardiovascular Risk Factor
  • Nutritional and Metabolic Diseases

Interventions

OTHER

cup of espresso coffee

Subjects will consume the assigned treatment for one month. Espresso coffee will be prepared by using coffee capsules. Serving size: approximately 45 mL. The last day of the intervention is the sampling day.

OTHER

cocoa-based products containing coffee

Subjects will consume the assigned treatment (2 products per serving) for one month. Serving size: approximately 37 g. The last day of the intervention is the sampling day.

Sponsors & Collaborators

  • University of Parma

    lead OTHER

Principal Investigators

  • Daniele Del Rio, Ph.D. · University of Parma

  • Pedro M Mena Parreño, Ph.D. · University of Parma

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-10
Primary Completion
2017-10-20
Completion
2017-10-20

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03166540 on ClinicalTrials.gov