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Physiological Effects of New Polyphenol-enriched Foods in Humans

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vincenzo Fogliano, Federico II University
ClinicalTrials.gov Identifier:
NCT01288859
First received: January 27, 2011
Last updated: July 31, 2012
Last verified: July 2012
History of Changes
  Purpose

Polyphenolic compounds exert several health benefits depending on bioavailability. Encapsulation may improve bioavailability of these compounds.This study will evaluate bioavailability of some polyphenols (curcumin and cocoa polyphenols) from new enriched-foods. In particular bread and nut based creams will be used as food matrices to include free or encapsulated polyphenols.


Condition Intervention
Healthy
 Other: free curcumin
Other: encapsulated curcumin
Other: encapsulated curcumin + PQG
Other: free cocoa polyphenol
Other: encapsulated cocoa polyphenols
Other: control nut cream

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Physiological Effects of New Polyphenol-enriched Foods in Healthy Humans

Resource links provided by NLM:

Drug Information available for: Curcumin
U.S. FDA Resources

Further study details as provided by Federico II University:

Primary Outcome Measures:
  • Serum Polyphenol Concentrations Over 24h From Food Consumption [ Time Frame: 0, 0.5, 1, 2, 4, 6, and 24 hours post‐dose ] [ Designated as safety issue: No ]
    Area Under the Curves (AUC) from 0 to 24h of parent polyphenols was calculated using a trapezoidal rule applied to the concentration-time curves of compounds.

  • Urinary Excretion of Total Polyphenols [ Time Frame: Time intervals: 0-2, 2-4, 4-6, 6-8, 10-24 hours post‐dose. ] [ Designated as safety issue: No ]
    Area Under the Curve (AUC) from 0 to 24h of total polyphenols (sum of parent polyphenols and metabolites)was calculated using a trapezoidal rule applied to the urinary concentration-time curves of compounds.

  • Amount of Total Fecal Polyphenols [ Time Frame: 0 and 24 hours post‐dose. ] [ Designated as safety issue: No ]
    Amount of parent polyphenols and metabolites in feces was calculated by multiplying net concentrations by the amount of feces.


Enrollment: 10
Study Start Date: December 2010
Study Completion Date: July 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: encapsulated curcumin Other: encapsulated curcumin
encapsulated curcumin-enriched bread, 1g/100g bread, 200g bread/day
Experimental: encapsulated curcumin + PQG
PQG means Piperine, Quercetin and Genistein
 Other: encapsulated curcumin + PQG
bread enriched with encapsulated curcumin plus piperine, quercetin and genistein, 1g/100g bread, 200g bread/day
Active Comparator: free cocoa polyphenol Other: free cocoa polyphenol
nut cream enriched with free cocoa polyphenols, 1,5 g/100g cream, 100g/day per 1 day
Placebo Comparator: control Other: control nut cream
nut cream, cocoa polyphenols 0g/100g cream, 100 g/day per 1 day
Experimental: encapsulated cocoa polyphenols Other: encapsulated cocoa polyphenols
nut cream enriched with encapsulated cocoa polyphenols, 1,5 g/100g cream, 100g/day per 1 day
Active Comparator: free curcumin
Subjects will consume bread added with free curcumin
 Other: free curcumin
free curcumin in bread, dosage 1g/100g, 200g/day per 1 day

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 - 45 years old, male and female
  • Healthy by medical assessment
  • Normal weight: BMI 18 - 25
  • Sign of a written informed consent

Exclusion Criteria:

  • Age > 18 and < 45 years old
  • Pregnancy or breastfeeding
  • Intestinal or metabolic diseases/disorders such as diabetic, renal, hepatic, hypertension, pancreatic or ulcer, including lactose-intolerance
  • Previous abdominal/gastrointestinal surgery
  • Regular consumption of medication
  • Antibiotic therapy within 2 months previous the study
  • Food allergies and intolerances (celiac disease, lactose intolerance, nut allergy etc)
  • Unwilling to consume experimental foods
  • Concurrent participation or having participated to another clinical trial during the last 3 weeks
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01288859

Locations
Italy
Department of Food Science
Portici, Italy, 80055
Sponsors and Collaborators
Federico II University
Investigators
Principal Investigator: Vincenzo Fogliano, Professor University of Naples
Study Director: Paola Vitaglione, Researcher University of Naples
  More Information

No publications provided

Responsible Party: Vincenzo Fogliano, Professor, Federico II University
ClinicalTrials.gov Identifier: NCT01288859     History of Changes
Other Study ID Numbers: DSA-FF-01
Study First Received: January 27, 2011
Results First Received: July 25, 2011
Last Updated: July 31, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Federico II University:
polyphenols
curcumin
bioavailability
cocoa

Additional relevant MeSH terms:
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013