Physiological Effects of New Polyphenol-enriched Foods in Humans
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Dec 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 27, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedFirst Posted
Study publicly available on registry
February 3, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedResults Posted
Study results publicly available
August 1, 2012
CompletedAugust 1, 2012
July 1, 2012
2 months
January 27, 2011
July 25, 2011
July 31, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Serum Polyphenol Concentrations Over 24h From Food Consumption
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.
0, 0.5, 1, 2, 4, 6, and 24 hours post-dose
Urinary Excretion of Total Polyphenols
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.
Time intervals: 0-2, 2-4, 4-6, 6-8, 10-24 hours post-dose.
Amount of Total Fecal Polyphenols
Amount of parent polyphenols and metabolites in feces was calculated by multiplying net concentrations by the amount of feces.
0 and 24 hours post-dose.
Study Arms (6)
encapsulated curcumin
EXPERIMENTALencapsulated curcumin + PQG
EXPERIMENTALPQG means Piperine, Quercetin and Genistein
free cocoa polyphenol
ACTIVE COMPARATORcontrol
PLACEBO COMPARATORencapsulated cocoa polyphenols
EXPERIMENTALfree curcumin
ACTIVE COMPARATORSubjects will consume bread added with free curcumin
Interventions
encapsulated curcumin-enriched bread, 1g/100g bread, 200g bread/day
bread enriched with encapsulated curcumin plus piperine, quercetin and genistein, 1g/100g bread, 200g bread/day
nut cream enriched with free cocoa polyphenols, 1,5 g/100g cream, 100g/day per 1 day
nut cream enriched with encapsulated cocoa polyphenols, 1,5 g/100g cream, 100g/day per 1 day
Eligibility Criteria
You may qualify if:
- years old, male and female
- Healthy by medical assessment
- Normal weight: BMI 18 - 25
- Sign of a written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Food Science
Portici, 80055, Italy
Results Point of Contact
- Title
- Prof. Vincenzo Fogliano
- Organization
- University of Naples
Study Officials
- PRINCIPAL INVESTIGATOR
Vincenzo Fogliano, Professor
University of Naples
- STUDY DIRECTOR
Paola Vitaglione, Researcher
University of Naples
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 27, 2011
First Posted
February 3, 2011
Study Start
December 1, 2010
Primary Completion
February 1, 2011
Study Completion
July 1, 2011
Last Updated
August 1, 2012
Results First Posted
August 1, 2012
Record last verified: 2012-07