Patients receive curcumin PO BID or TID and piperine extract (standardized) PO on days 1-7 in the absence of disease progression or unacceptable toxicity.

Bladder Spasm

Malignant Neoplasm

Pain

Urinary Urgency

Curcumin

Laboratory Biomarker Analysis

Piperine Extract (Standardized)

Quality-of-Life Assessment

Mayo Clinic

Curcumin and Piperine in Reducing Inflammation for Ureteral Stent-Induced Symptoms in Patients With Cancer

Phase 1 Pilot Study of Curcumin and Piperine to Derive a Safe, Optimal Biologic Dose for Ureteral Stent-Induced Symptoms in Cancer Patients

Examined in an exploratory and hypothesis-generating fashion. The number and severity of all adverse events (overall, by dose-level, and by tumor type) will be tabulated and summarized in this patient population. The grade 2+ adverse events will also be described and summarized in a similar fashion.

The MTD of curcumin in combination with piperine is defined as the highest safely tolerated dose level where at most 1 out of 6 patients experience a dose limiting toxicity (DLT) with the next higher dose having at least 2 patients out of a maximum of 6 patients experiencing a DLT. DLT will be assessed using Common Terminology Criteria for Adverse Events version 4.0. Examined in an exploratory and hypothesis-generating fashion.

Examined in an exploratory and hypothesis-generating fashion.

Reported descriptively. Graphical methods and descriptive statistics will be used to describe the QOL data at baseline and after treatment. Change in QOL from baseline will be assessed via the paired t-test or non-parametric equivalent (Wilcoxon Signed-Rank test). The questions from the USSQ will be summarized descriptively via frequency tables.

Graphical methods and descriptive statistics will be used to summarize the prostaglandin E2 concentration data. This will be done overall and by dose level. Changes will be summarized by reporting the mean and median percent change from baseline to post-treatment. Percent and absolute change from baseline will also be assessed using the Wilcoxon Signed-Rank test. Fisher's Exact test will be used for assessing the association between categorical variables and the t-test will be used for comparing prostaglandin E2 concentration data across different patient subgroups of interest.

National Cancer Institute (NCI)

volunteers will receive a single dose of 8 actuations of Sativex® which will be administrated within 1-2 min by the study physician. The dose of THC and CBD to be administered is the following: THC 21.6 mg and CBD 20 mg. Sativex® actuations will be directed sublingually and at the buccal mucosa.

12 volunteers will receive a single oral dose of THC:CBD P-PNL capsule with 200 mL of water. The dose of THC and CBD to be administered is the same as in the Sativex arm: THC 21.6 mg and CBD 20 mg.

Sativex buccal spray

a capsule containing Cannabidiol and Tetrahydrocannabinol combination

CBD-THC-Piperine-PNL capsule

Hadassah medical organization

Bioequivalence Assessment of Oral Administration Vs. Oral Spray of a Cannabinoids (Tetrahydrocannabinol and Cannabidiol)

Bioequivalence Assessment of Oral Administration Vs. Oral Spray of a Cannabinoid Combination (Δ9 -Tetrahydrocannabinol (THC) and Cannabidiol (CBD) In 1:1 Ratio)

Assessment of the metabolic profile of major THC's and CBD's metabolites:
11-hydroxy-THC, 11-nor-9-carboxy-THC and CBD-glucoronide in healthy volunteers. Plasma metabolites concentrations will be determined using HPLC-MS/MS validated assay. The unit of measure will be provided as ng/ml.

Hadassah Medical Organization

Resveratrol 2.5 grams x 1 dose and Piperine 5 mg x 1 dose

Resveratrol 2.5 grams x 1 dose and Piperine 25 mg x 1 dose

Focus of the Study: Normal Volunteers

Resveratrol

University of Wisconsin

Resveratrol With or Without Piperine to Enhance Plasma Levels of Resveratrol

A Randomized, Double-Blind Pilot Trial of Resveratrol With or Without Piperine to Enhance Plasma Levels of Resveratrol

Blood levels of Resveratrol/Piperine will be measured

University of Wisconsin, Madison

National Institutes of Health (NIH)

PQG means Piperine, Quercetin and Genistein

Subjects will consume bread added with free curcumin

All participants followed all the periods

All Study Participants

Sex: Female, Male

Region of Enrollment

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.

subjects consumed bread enriched with free curcumin

Free Curcumin

subjects consumed bread enriched with encapsulated curcumin

Encapsulated Curcumin

subjects consumed bread enriched with encapsulated curcumin plus piperine, quercetin and genistein

Encapsulated Curcumin + PQG

Control Cream

subjects consumed cocoa-nut cream enriched with cocoa polyphenols in the free form

Free Cocoa Polyphenols

subjects consumed cocoa-nut cream enriched with encapsulated cocoa polyphenols

Encapsulated Cocoa Polyphenols

Serum Polyphenol Concentrations Over 24h From Food Consumption

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.

subjects consumed bread containing encapsulated curcumin

subjects consumed bread containing encapsulated curcumin plus PQG (i.e. Piperine, Quercetin and Genistein)

subjects consumed nut creams added with cocoa polyphenols

Free Cocoa Polyphenol

Subjects consumed white bread or nut cream

Control

subjects consumed nut creams added with encapsulate cocoa-polyphenols

Subjects consumed bread added with free curcumin

Urinary Excretion of Total Polyphenols

Amount of parent polyphenols and metabolites in feces was calculated by multiplying net concentrations by the amount of feces.

Amount of Total Fecal Polyphenols

Subjects consumed 2 bread portions/day of bread enriched with micro-encapsulated curcumin(1g/100g portion, i.e. 2g/day)

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.

Subjects consumed 3 nut cream portions (33g each) enriched with cocoa polyphenols at dosage of 1.5g/day.

Subjects consumed 3 nut cream portions (33g each).

Subjects consumed 3 nut cream portions (33g each) enriched with encapsulated cocoa polyphenols at dosage of 1.5g/day.

Subjects consumed 2 portions of bread enriched with free curcumin (1g/100g portion, i.e. 2g/day)

Free Then Encapsulated Curcumin (1 Day)

Washout Period of 1 Week

Encapsulated Then Free Curcumin (1 Day)

Enc Curc + PQG Then Free Polyph. (1 Day)

Free Polyph. Then Enc Curc + PQG (1 Day)

Enc Polyph. Then Control Cream (1 Day)

Control Cream Then Enc Polyph. (1 Day)

Prof. Vincenzo Fogliano

Healthy

free curcumin in bread, dosage 1g/100g, 200g/day per 1 day

free curcumin

encapsulated curcumin-enriched bread, 1g/100g bread, 200g bread/day

encapsulated curcumin

bread enriched with encapsulated curcumin plus piperine, quercetin and genistein, 1g/100g bread, 200g bread/day

encapsulated curcumin + PQG

nut cream enriched with free cocoa polyphenols, 1,5 g/100g cream, 100g/day per 1 day

free cocoa polyphenol

nut cream enriched with encapsulated cocoa polyphenols, 1,5 g/100g cream, 100g/day per 1 day

piperine/rakovina

Curcumin and Piperine in Reducing Inflammation for Ureteral Stent-Induced Symptoms in Patients With Cancer

Bioequivalence Assessment of Oral Administration Vs. Oral Spray of a Cannabinoids (Tetrahydrocannabinol and Cannabidiol)

Resveratrol With or Without Piperine to Enhance Plasma Levels of Resveratrol

Physiological Effects of New Polyphenol-enriched Foods in Humans

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