The Pocket-4-Life project, bioavailability and beneficial properties of the bioactive compounds of espresso coffee and cocoa-based confectionery containing coffee: study protocol for a randomized cross-over trial

Pedro Mena, Michele Tassotti, Daniela Martini, Alice Rosi, Furio Brighenti, Daniele Del Rio, Pedro Mena, Michele Tassotti, Daniela Martini, Alice Rosi, Furio Brighenti, Daniele Del Rio

Abstract

Background: Coffee is an important source of bioactive compounds, including caffeine, phenolic compounds (mainly chlorogenic acids), trigonelline, and diterpenes. Several studies have highlighted the preventive effects of coffee consumption on major cardiometabolic diseases, but the impact of coffee dosage on markers of cardiometabolic risk is not well understood. Moreover, the pool of coffee-derived circulating metabolites and the contribution of each metabolite to disease prevention still need to be evaluated in real-life settings. The aim of this study will be to define the bioavailability and beneficial properties of coffee bioactive compounds on the basis of different levels of consumption, by using an innovative experimental design. The contribution of cocoa-based products containing coffee to the pool of circulating metabolites and their putative bioactivity will also be investigated.

Methods: A three-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, and 1 cup of espresso coffee plus 2 cocoa-based products containing coffee twice per day. The last day of each treatment, blood and urine samples will be collected at specific time points, up to 24 hours following the consumption of the first product. At the end of each treatment the same protocol will be repeated, switching the allocation group. Besides the bioavailability of the coffee/cocoa bioactive compounds, the effect of the coffee/cocoa consumption on several cardiometabolic risk factors (anthropometric measures, blood pressure, inflammatory markers, trimethylamine N-oxide, nitric oxide, blood lipids, fasting indices of glucose/insulin metabolism, DNA damage, eicosanoids, and nutri-metabolomics) will be investigated.

Discussion: Results will provide information on the bioavailability of the main groups of phytochemicals in coffee and on their modulation by the level of consumption. Findings will also show the circulating metabolites and their bioactivity when coffee consumption is substituted with the intake of cocoa-based products containing coffee. Finally, the effect of different levels of 1-month coffee consumption on cardiometabolic risk factors will be elucidated, likely providing additional insights on the role of coffee in the protection against chronic diseases.

Trial registration: ClinicalTrials.gov, NCT03166540 . Registered on May 21, 2017.

Keywords: Bioavailability; Caffeine; Caffeoylquinic acid; Cardiometabolic risk factors; Cocoa; Coffee; Diterpenes; Flavan-3-ols; Pharmacokinetic; Trigonelline.

Conflict of interest statement

Ethics approval and consent to participate

The Ethics Committee of the University of Parma approved the study on October 12, 2016 (AZOSPR/0036174/6.2.2.). The protocol was modified to include further analysis and the ethical approval for these amendments was granted on April 19, 2017 (AZOSPR/0015693/6.2.2.). All trial participants will provide full written informed consent.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study design and sampling day (in the blue box) scheme. HC high consumers, LC low consumers, MC medium consumers, SD sampling day
Fig. 2
Fig. 2
SPIRIT figure: summarizes the allocation, interventions, and outcomes of the study
Fig. 3
Fig. 3
Modelled pharmacokinetic profile recorded after repeated consumption of coffee along the day. Cmax maximum concentration, Cavg average concentration, Cmin minimum concentration, SD sampling day

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