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Physiological Effects of New Polyphenol-enriched Foods in Humans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01288859
Recruitment Status : Completed
First Posted : February 3, 2011
Results First Posted : August 1, 2012
Last Update Posted : August 1, 2012
Information provided by (Responsible Party):
Vincenzo Fogliano, Federico II University

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Other: free curcumin Other: encapsulated curcumin Other: encapsulated curcumin + PQG Other: free cocoa polyphenol Other: encapsulated cocoa polyphenols Other: control nut cream Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Physiological Effects of New Polyphenol-enriched Foods in Healthy Humans
Study Start Date : December 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Serum Polyphenol Concentrations Over 24h From Food Consumption [ Time Frame: 0, 0.5, 1, 2, 4, 6, and 24 hours post-dose ]
    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.

  2. Urinary Excretion of Total Polyphenols [ Time Frame: Time intervals: 0-2, 2-4, 4-6, 6-8, 10-24 hours post-dose. ]
    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.

  3. Amount of Total Fecal Polyphenols [ Time Frame: 0 and 24 hours post-dose. ]
    Amount of parent polyphenols and metabolites in feces was calculated by multiplying net concentrations by the amount of feces.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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 identifier (NCT number): NCT01288859

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Department of Food Science
Portici, Italy, 80055
Sponsors and Collaborators
Federico II University
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Principal Investigator: Vincenzo Fogliano, Professor University of Naples
Study Director: Paola Vitaglione, Researcher University of Naples
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Responsible Party: Vincenzo Fogliano, Professor, Federico II University Identifier: NCT01288859    
Other Study ID Numbers: DSA-FF-01
First Posted: February 3, 2011    Key Record Dates
Results First Posted: August 1, 2012
Last Update Posted: August 1, 2012
Last Verified: July 2012
Keywords provided by Vincenzo Fogliano, Federico II University:
Additional relevant MeSH terms:
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Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action