NCT03166540: P4L

Bioavailability and Beneficial Properties of Coffee and Cocoa Bioactive Compounds

Completed NA Last updated 25 October 2017

What this trial tests

NA trial testing cup of espresso coffee in Diet Modification in 21 participants. Completed in 20 October 2017.

Timeline

10 May 2017

Primary endpoint
20 October 2017

20 October 2017

Quick facts

Lead sponsor	University of Parma
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	basic science
Enrollment	21
Start date	10 May 2017
Primary completion	20 October 2017
Estimated completion	20 October 2017
Sites	1 location across Italy

Drugs / interventions tested

• cup of espresso coffee
• cocoa-based products containing coffee

Conditions studied

• Diet Modification — all drugs for Diet Modification →
• Cardiovascular Risk Factor — all drugs for Cardiovascular Risk Factor →
• Nutritional and Metabolic Diseases — all drugs for Nutritional and Metabolic Diseases →

Sponsor

University of Parma

Who can join

Adults 18 to 60, any sex, with Diet Modification or Cardiovascular Risk Factor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effect of different patterns of consumption of coffee and a cocoa-based product containing coffee on the nutrikinetics and urinary excretion of phenolic compounds.
   Mena P, Bresciani L, Tassotti M, Rosi A, et al · · 2021 · cited 16× · PMID 34582552 · DOI 10.1093/ajcn/nqab299
2. 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.
   Mena P, Tassotti M, Martini D, Rosi A, et al · · 2017 · cited 15× · PMID 29121975 · DOI 10.1186/s13063-017-2271-2
3. Effect of coffee and cocoa-based confectionery containing coffee on markers of cardiometabolic health: results from the pocket-4-life project.
   Martini D, Rosi A, Tassotti M, Antonini M, et al · · 2021 · cited 12× · PMID 32728879 · DOI 10.1007/s00394-020-02347-5
4. Effect of Coffee and Cocoa-Based Confectionery Containing Coffee on Markers of DNA Damage and Lipid Peroxidation Products: Results from a Human Intervention Study.
   Martini D, Domínguez-Perles R, Rosi A, Tassotti M, et al · · 2021 · cited 8× · PMID 34371907 · DOI 10.3390/nu13072399