Trial Outcomes & Findings for Physiological Effects of New Polyphenol-enriched Foods in Humans (NCT NCT01288859)

Last Updated: 2012-08-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

0, 0.5, 1, 2, 4, 6, and 24 hours post-dose

Results posted on

2012-08-01

Participant Flow

The recruitment was performed at the ambulatory of Department of Food Science (University of Naples) among students of Agriculture Faculty. It began on December 2010 up to February 2011.

Subjects were enrolled after signing a Consent Form and were randomized to the treatments. All subjects enrolled completed the study.

Participant milestones

Participant milestones
Measure	Encapsulated Curcumin Subjects consumed 2 bread portions/day of bread enriched with micro-encapsulated curcumin(1g/100g portion, i.e. 2g/day)	Encapsulated Curcumin + PQG Subjects consumed 2 bread portions/day of bread enriched with micro-capsules containing curcumin at dosage of 1 g/100 g plus 0.1% of Piperine, Quercetin and Genistein (PQG) (2g curcumin + 0.2g PQG/day) for one day.	Free Cocoa Polyphenol Subjects consumed 3 nut cream portions (33g each) enriched with cocoa polyphenols at dosage of 1.5g/day.	Control Cream Subjects consumed 3 nut cream portions (33g each).	Encapsulated Cocoa Polyphenols Subjects consumed 3 nut cream portions (33g each) enriched with encapsulated cocoa polyphenols at dosage of 1.5g/day.	Free Curcumin Subjects consumed 2 portions of bread enriched with free curcumin (1g/100g portion, i.e. 2g/day)
Free Then Encapsulated Curcumin (1 Day) STARTED	5	0	0	0	0	5
Free Then Encapsulated Curcumin (1 Day) COMPLETED	5	0	0	0	0	5
Free Then Encapsulated Curcumin (1 Day) NOT COMPLETED	0	0	0	0	0	0
Washout Period of 1 Week STARTED	0	0	0	5	5	0
Washout Period of 1 Week COMPLETED	0	0	0	5	5	0
Washout Period of 1 Week NOT COMPLETED	0	0	0	0	0	0
Encapsulated Then Free Curcumin (1 Day) STARTED	5	0	0	0	0	5
Encapsulated Then Free Curcumin (1 Day) COMPLETED	5	0	0	0	0	5
Encapsulated Then Free Curcumin (1 Day) NOT COMPLETED	0	0	0	0	0	0
Enc Curc + PQG Then Free Polyph. (1 Day) STARTED	0	5	5	0	0	0
Enc Curc + PQG Then Free Polyph. (1 Day) COMPLETED	0	5	5	0	0	0
Enc Curc + PQG Then Free Polyph. (1 Day) NOT COMPLETED	0	0	0	0	0	0
Free Polyph. Then Enc Curc + PQG (1 Day) STARTED	0	5	5	0	0	0
Free Polyph. Then Enc Curc + PQG (1 Day) COMPLETED	0	5	5	0	0	0
Free Polyph. Then Enc Curc + PQG (1 Day) NOT COMPLETED	0	0	0	0	0	0
Enc Polyph. Then Control Cream (1 Day) STARTED	0	0	0	5	5	0
Enc Polyph. Then Control Cream (1 Day) COMPLETED	0	0	0	5	5	0
Enc Polyph. Then Control Cream (1 Day) NOT COMPLETED	0	0	0	0	0	0
Control Cream Then Enc Polyph. (1 Day) STARTED	0	0	0	5	5	0
Control Cream Then Enc Polyph. (1 Day) COMPLETED	0	0	0	5	5	0
Control Cream Then Enc Polyph. (1 Day) NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Physiological Effects of New Polyphenol-enriched Foods in Humans

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=10 Participants All participants followed all the periods
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	31 years STANDARD_DEVIATION 2 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment Italy	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 0, 0.5, 1, 2, 4, 6, and 24 hours post-dose

Population: The number of subjects was based on power calculations derived from our previous study. We calculated that, at α = 0.05 with a power of 80%, 8 subjects would allow us to detect a 20% difference in serum and urinary concentrations of parental compounds, glucuronides and phenolic acids.

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.

Outcome measures

Outcome measures
Measure	Free Curcumin n=10 Participants subjects consumed bread enriched with free curcumin	Encapsulated Curcumin n=10 Participants subjects consumed bread enriched with encapsulated curcumin	Encapsulated Curcumin + PQG n=10 Participants subjects consumed bread enriched with encapsulated curcumin plus piperine, quercetin and genistein	Control Cream n=10 Participants subjects consumed cocoa-nut cream	Free Cocoa Polyphenols n=10 Participants subjects consumed cocoa-nut cream enriched with cocoa polyphenols in the free form	Encapsulated Cocoa Polyphenols n=10 Participants subjects consumed cocoa-nut cream enriched with encapsulated cocoa polyphenols
Serum Polyphenol Concentrations Over 24h From Food Consumption	1.7 nmol*h/L Standard Error 0.1	12.1 nmol*h/L Standard Error 1.1	7.7 nmol*h/L Standard Error 1.8	0.01 nmol*h/L Standard Error 0.00	7.3 nmol*h/L Standard Error 0.9	0.5 nmol*h/L Standard Error 0.1

PRIMARY outcome

Timeframe: Time intervals: 0-2, 2-4, 4-6, 6-8, 10-24 hours post-dose.

Population: Basing on power analysis calculation on a previous work

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.

Outcome measures

Outcome measures
Measure	Free Curcumin n=10 Participants subjects consumed bread enriched with free curcumin	Encapsulated Curcumin n=10 Participants subjects consumed bread enriched with encapsulated curcumin	Encapsulated Curcumin + PQG n=10 Participants subjects consumed bread enriched with encapsulated curcumin plus piperine, quercetin and genistein	Control Cream n=10 Participants subjects consumed cocoa-nut cream	Free Cocoa Polyphenols n=10 Participants subjects consumed cocoa-nut cream enriched with cocoa polyphenols in the free form	Encapsulated Cocoa Polyphenols n=10 Participants subjects consumed cocoa-nut cream enriched with encapsulated cocoa polyphenols
Urinary Excretion of Total Polyphenols	2.0 nmol•h/L Standard Error 0.8	2.21 nmol•h/L Standard Error 1.27	9.67 nmol•h/L Standard Error 6.7	19.1 nmol•h/L Standard Error 12.3	4.92 nmol•h/L Standard Error 3.36	1.31 nmol•h/L Standard Error 0.81

PRIMARY outcome

Timeframe: 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.