N/A N=10 Randomized Single-blind Basic Science

Physiological Effects of New Polyphenol-enriched Foods in Humans

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT01288859 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2012

Primary outcome: Primary: Serum Polyphenol Concentrations Over 24h From Food Consumption — 1.7; 12.1; 7.7; 0.01 nmol*h/L — p=0.02

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: free curcumin (Other); encapsulated curcumin (Other); encapsulated curcumin + PQG (Other); free cocoa polyphenol (Other); encapsulated cocoa polyphenols (Other); control nut cream (Other)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Federico II University
Primary completion: Feb 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Serum Polyphenol Concentrations Over 24h From Food Consumption	1.7; 12.1; 7.7; 0.01; 7.3; 0.5	0.02 sig
PRIMARY Urinary Excretion of Total Polyphenols	2.0; 2.21; 9.67; 19.1; 4.92; 1.31	0.01 sig
PRIMARY Amount of Total Fecal Polyphenols	3.49; 0.49; 27.98; 4.27; 150.97; 0.59	0.04 sig

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01288859). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.