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Bioavailability and Beneficial Properties of Coffee and Cocoa Bioactive Compounds (P4L)

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ClinicalTrials.gov Identifier: NCT03166540
Recruitment Status : Completed
First Posted : May 25, 2017
Last Update Posted : October 25, 2017
Sponsor:
Information provided by (Responsible Party):
Daniele Del Rio, University of Parma

Brief 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.


Condition or disease Intervention/treatment Phase
Diet Modification Cardiovascular Risk Factor Nutritional and Metabolic Diseases Other: cup of espresso coffee Other: cocoa-based products containing coffee Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Sample codification, done by the PI, will be hidden to the researchers analysing the samples.
Primary Purpose: Basic Science
Official Title: Bioavailability and Beneficial Properties of Espresso Coffee and Confectionery Derived Coffee Bioactive Compounds
Actual Study Start Date : May 10, 2017
Actual Primary Completion Date : October 20, 2017
Actual Study Completion Date : October 20, 2017

Arm Intervention/treatment
Experimental: low consumers
1 cup of espresso coffee/day at 9.00 A.M. for 1 month
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.

Experimental: high consumers
3 cup of espresso coffee/day at 9.00 A.M. 12.00 P.M. and 3.00 P.M. for 1 month
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.

Experimental: medium consumers
1 cup of espresso coffee at 9.00 A.M. + cocoa-based products containing coffee at 12.00 P.M. and 3.00 P.M. for 1 month
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.




Primary Outcome Measures :
  1. Daily mean concentration of phenolic metabolites [ Time Frame: 24 hours (0 -overnight fasting-, 30, 60, 120, 180, 240, 300, 360, 420, 480, 540, 1440 -overnight fasting- minutes) ]
    Assessment of the daily mean concentration of coffee derived plasma circulating phenolic metabolites


Secondary Outcome Measures :
  1. Coffee-derived plasma circulating bioactives [ Time Frame: 24 hours (0 -overnight fasting-, 30, 60, 120, 180, 240, 300, 360, 420, 480, 540, 1440 -overnight fasting- minutes) ]
    Profile of metabolites coming from coffee phytochemicals (phenolic compounds, trigonelline, caffeine, and diterpenes) in plasma

  2. Coffee-derived bioactives in urine [ Time Frame: 24 hours (0 -overnight fasting-, 180, 360, 540, 1440 -overnight fasting- minutes) ]
    Profile of metabolites coming from coffee phytochemicals (phenolic compounds, trigonelline, caffeine, and diterpenes) in urine

  3. Cocoa-derived plasma circulating bioactives [ Time Frame: 24 hours (0 -overnight fasting-, 30, 60, 120, 180, 240, 300, 360, 420, 480, 540, 1440 -overnight fasting- minutes) ]
    Profile of metabolites coming from cocoa phytochemicals (phenolic compounds and theobromine) in plasma

  4. Cocoa-derived bioactives in urine [ Time Frame: 24 hours (0 -overnight fasting-, 180, 360, 540, 1440 -overnight fasting- minutes) ]
    Profile of metabolites coming from cocoa phytochemicals (phenolic compounds and theobromine) in urine

  5. Blood Pressure [ Time Frame: two time (0 -overnight fasting-, 1 month-fasting-) ]
    Systolic and diastolic blood pressure

  6. Body Mass Index (BMI) [ Time Frame: two time (0 -overnight fasting-, 1 month-fasting-) ]
    Weight (in kg) and height (in m) will be combined to report BMI in kg/m2

  7. Waist circumference [ Time Frame: two time (0 -overnight fasting-, 1 month-fasting-) ]
  8. Trimethyl-ammine-N-oxide (TMAO) in plasma [ Time Frame: 24 hours (0 -overnight fasting-, 30, 60, 120, 180, 240, 300, 360, 420, 480, 540, 1440 -overnight fasting- minutes) ]
  9. Trimethyl-ammine-N-oxide (TMAO) in urine [ Time Frame: 24 hours (0 -overnight fasting-, 180, 360, 540, 1440 -overnight fasting- minutes) ]
  10. Nitric oxide (NO) in plasma [ Time Frame: 1440 -overnight fasting- minutes ]
  11. Blood lipids [ Time Frame: 1440 -overnight fasting- minutes ]
    Total cholesterol, HDL, LDL, triglycerides

  12. Glucose and Insulin [ Time Frame: 1440 -overnight fasting- minutes ]
    Fasting glucose and fasting insulin

  13. DNA damage [ Time Frame: 24 hours (0 -overnight fasting-, 60, 240, 420, 1440 -overnight fasting- minutes) ]
    Assessed by using the Comet assay

  14. DNA catabolites [ Time Frame: 24 hours (0 -overnight fasting-, 60, 240, 420, 1440 -overnight fasting- minutes) ]
    Assessed by using LC-MS for individual detection and quantification

  15. Nutri-metabolomics in plasma [ Time Frame: 1440 -overnight fasting- minutes ]
    Metabolomics will be carried out in fasting plasma to unravel the potential metabolic pathways of molecules present in the food matrix

  16. Nutri-metabolomics in urine [ Time Frame: 24 hours (0 -overnight fasting-, 180, 360, 540, 1440 -overnight fasting- minutes) ]
    Metabolomics will be carried out in urine to unravel the potential metabolic pathways of molecules present in the food matrix

  17. Eicosanoids in urine [ Time Frame: 24 hours (0 -overnight fasting-, 180, 360, 540, 1440 -overnight fasting- minutes) ]
  18. Inflammatory markers in plasma [ Time Frame: 1440 -overnight fasting- minutes ]
    Main inflammatory markers associated with coffee consumption



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • adult
  • both genders
  • healthy
  • normal weight (BMI 18-25)
  • regular coffee consumers of 1-5 cups per day

Exclusion Criteria:

  • younger than 18 y.o. or older than 60 y.o.
  • clinically diagnosis for metabolic, renal or digestive disorders
  • regular consumption of medication
  • antibiotic therapy taken within the last 3 months
  • intense physical activity
  • pregnancy or lactation
  • underweight or overweight/obese
  • no regular consumption of coffee or regular intake exceeding 5 coffees/day

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03166540


Locations
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Italy
Department of Food and Drug, University of Parma
Parma, Italy, 43125
Sponsors and Collaborators
University of Parma
Investigators
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Principal Investigator: Daniele Del Rio, Ph.D. University of Parma
Study Director: Pedro M Mena Parreño, Ph.D. University of Parma

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Daniele Del Rio, Prof., University of Parma
ClinicalTrials.gov Identifier: NCT03166540     History of Changes
Other Study ID Numbers: DDR-P4L
First Posted: May 25, 2017    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Daniele Del Rio, University of Parma:
coffee
cocoa
bioavailability
pharmacokinetics
cardiometabolic risk factors
caffeoylquinic acids
flavan-3-ol
caffeine
trigonelline
diterpene

Additional relevant MeSH terms:
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Metabolic Diseases