HealthyNCT01288859
Physiological Effects of New Polyphenol-enriched Foods in Humans
A study testing free curcumin, encapsulated curcumin and encapsulated curcumin + PQG in people with Healthy, run by Federico II University at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- free curcumin, encapsulated curcumin and encapsulated curcumin + PQG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2010to Jul 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 - 45 years old, male and female
- Healthy by medical assessment
- Normal weight: BMI 18 - 25
- Sign of a written informed consent
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physiological Effects of New Polyphenol-enriched Foods in Healthy Humans
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.
Read the detailed description
Polyphenolic compounds are abundant in foods and have been suggested to exert several health benefits including prevention of cancer, cardiovascular disease, suppressing inflammation, diabetes, etc. These properties are mediated by bioavailability of individual polyphenols that is, in turn, influenced by food properties (food matrix, technological processing, etc.), interaction with other compounds, and host related factors. Some well-studied dietary polyphenols include catechins from tea, curcumin from turmeric, procyanidins and anthocyanidins in grapes, berries, and dark chocolate. These compounds have strong antioxidative activities in vitro and have been suggested to have several beneficial health effects.
Curcumin, a phenolic compound deriving from turmeric spice, shows many biological and pharmacological effects, and clinical studies in humans proved that it's extremely safe and well tolerated even at very high doses (8-12 g/day). However, curcumin has not yet been approved as a therapeutic agent, because of its very low bioavailability depending on a poor absorption, rapid metabolism and rapid systemic clearance. Different approaches have been investigated to improve curcumin bioavailability. Among them, the use of adjuvants that interferes with metabolic pathways of curcumin, like piperine, represents one of the main strategies used to enhance its bioavailability. A further approach consists on manufacturing of curcumin containing liposomes, phospholipids complexes or nanoparticles. For polymer-based nanoparticles, maintenance of biological activity, increased absorption and delayed delivery was reported.
Cocoa based products are widely consumed in many countries, and indications of health benefits by some cocoa constituents, mainly polyphenols, have also been reported. Cocoa contains very high levels of polyphenols, in particular flavanols and among these, mainly epicatechins. The bioavailability of cocoa polyphenols has been measured in several human studies from acute consumption of cocoa rich beverages or chocolate. Monomeric flavonoids as well as dimeric and trimeric procyanidins were detected in human plasma over 2-3 hours from consumption. Plasma concentration of cocoa polyphenols were often in the nanomolar or low micromolar range. Donovan and coworkers demonstrated that commercial available chocolate samples contain a predominance of the less bioavailable (-)-catechin enantiomer as compared to the (+)-catechin which is present in most other plant derived foods. This may explain the relatively low bioavailability of catechins from chocolate and cocoa-containing products. The food matrix seems to be an important factor that may affect the bioavailability of cocoa polyphenols. For instance, proteins in the food matrix are supposed to form highly polymerized complexes with procyanidins, which can reduce bioaccessibility of these phenolic compounds. However, the potential negative effect of protein content in foods was not confirmed in a study that evaluated the cocoa polyphenols bioavailability after the intake of a milk-powder cocoa beverage. However, concurrent carbohydrates consumption seems to increase significantly the uptake of flavonols in humans. Little is known whether and to what extent oligomeric procyanidins from cocoa are absorbed. However, the biological activity of procyanidins with high polymerization degree may be partly attributed to their colonic breakdown products, including phenolic acids.
Actually there is also a growing interest in other biological properties of phenolic compounds in addition to their antioxidant effects; particularly, some evidences suggest that certain dietary phenols may modulate metabolic homeostasis. This is the case of chlorogenic acids, that are reported to play a potential role in modifying the pattern of intestinal glucose uptake and of other flavonoids (quercetin, catechins) that may modulate activation of GLP-1 receptor, involved in modulation of insulin and glucagon secretion, gastric emptying, and appetite.
In this randomized, crossover trial, serum, urine and fecal concentrations of curcumin and cocoa polyphenols, their parental compounds, metabolites and phenolic acids, following a two day multi-dose administration with six food sources, will be measured. All volunteers will undergo to six interventions - bread enriched with three different forms of curcumin (free, encapsulated, and encapsulated plus piperine) and nut based creams enriched with cocoa polyphenols (free or encapsulated one) or control cream (without enrichment). A one-week wash-out period will be included between two sequential treatments. Blood, urine and feces will be collected at time 0 (baseline), 24, and 48 hours; further blood samples at 0.5, 1, 2, 4, 6 hours after consumption of the first meal, and urine samples at 2 hours time intervals up to 10 hours, will be collected too. In particular, area under the curve (AUC) of serum and urine concentrations of parental compounds and metabolites in the time interval 0-24 hours will be calculated as primary outcomes. In addition the amount of total polyphenols in fecal samples will be measured.
- Conditions
- Healthy
- Being tested
- free curcumin, encapsulated curcumin, encapsulated curcumin + PQG, free cocoa polyphenol, encapsulated cocoa polyphenols
- Keywords
- polyphenols, curcumin, bioavailability, cocoa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
free curcuminOther
free curcumin in bread, dosage 1g/100g, 200g/day per 1 day
encapsulated curcuminOther
encapsulated curcumin-enriched bread, 1g/100g bread, 200g bread/day
encapsulated curcumin + PQGOther
bread enriched with encapsulated curcumin plus piperine, quercetin and genistein, 1g/100g bread, 200g bread/day
free cocoa polyphenolOther
nut cream enriched with free cocoa polyphenols, 1,5 g/100g cream, 100g/day per 1 day
encapsulated cocoa polyphenolsOther
nut cream enriched with encapsulated cocoa polyphenols, 1,5 g/100g cream, 100g/day per 1 day
control nut creamOther
nut cream, cocoa polyphenols 0g/100g cream, 100 g/day per 1 day
| Study group | Role | What they receive |
|---|---|---|
| encapsulated curcumin | Experimental | Not described Receives: Other: encapsulated curcumin |
| encapsulated curcumin + PQG | Experimental | PQG means Piperine, Quercetin and Genistein Receives: Other: encapsulated curcumin + PQG |
| free cocoa polyphenol | Active comparator | Not described Receives: Other: free cocoa polyphenol |
| control | Placebo comparator | Not described Receives: Other: control nut cream |
| encapsulated cocoa polyphenols | Experimental | Not described Receives: Other: encapsulated cocoa polyphenols |
| free curcumin | Active comparator | Subjects will consume bread added with free curcumin Receives: Other: free curcumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 0 and 24 hours post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2011 (estimated)
- Study startDec 2010
- Primary completionFeb 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vincenzo Fogliano, Federico II University
- Investigators
- Vincenzo Fogliano, Professor, Principal investigator, University of NaplesPaola Vitaglione, Researcher, Study director, University of Naples
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01288859
- Sponsor's protocol ID
- DSA-FF-01
- Status last verified
- Jul 2012
- First submitted
- 27 Jan 2011
- Last updated
- 1 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Effects of New Polyphenol-enriched Foods in Healthy Humans
- ClinicalTrials.gov ID
- NCT01288859
- Acronym / sponsor ID
- DSA-FF-01
- Conditions
- Healthy
- Keywords
- polyphenols, curcumin, bioavailability, cocoa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 3 Feb 2011 (estimated)
- Results
- Posted 1 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Polyphenolic compounds are abundant in foods and have been suggested to exert several health benefits including prevention of cancer, cardiovascular disease, suppressing inflammation, diabetes, etc. These properties are mediated by bioavailability of individual polyphenols that is, in turn, influenced by food properties (food matrix, technological processing, etc.), interaction with other compounds, and host related factors. Some well-studied dietary polyphenols include catechins from tea, curcumin from turmeric, procyanidins and anthocyanidins in grapes, berries, and dark chocolate. These compounds have strong antioxidative activities in vitro and have been suggested to have several beneficial health effects.
Curcumin, a phenolic compound deriving from turmeric spice, shows many biological and pharmacological effects, and clinical studies in humans proved that it's extremely safe and well tolerated even at very high doses (8-12 g/day). However, curcumin has not yet been approved as a therapeutic agent, because of its very low bioavailability depending on a poor absorption, rapid metabolism and rapid systemic clearance. Different approaches have been investigated to improve curcumin bioavailability. Among them, the use of adjuvants that interferes with metabolic pathways of curcumin, like piperine, represents one of the main strategies used to enhance its bioavailability. A further approach consists on manufacturing of curcumin containing liposomes, phospholipids complexes or nanoparticles. For polymer-based nanoparticles, maintenance of biological activity, increased absorption and delayed delivery was reported.
Cocoa based products are widely consumed in many countries, and indications of health benefits by some cocoa constituents, mainly polyphenols, have also been reported. Cocoa contains very high levels of polyphenols, in particular flavanols and among these, mainly epicatechins. The bioavailability of cocoa polyphenols has been measured in several human studies from acute consumption of cocoa rich beverages or chocolate. Monomeric flavonoids as well as dimeric and trimeric procyanidins were detected in human plasma over 2-3 hours from consumption. Plasma concentration of cocoa polyphenols were often in the nanomolar or low micromolar range. Donovan and coworkers demonstrated that commercial available chocolate samples contain a predominance of the less bioavailable (-)-catechin enantiomer as compared to the (+)-catechin which is present in most other plant derived foods. This may explain the relatively low bioavailability of catechins from chocolate and cocoa-containing products. The food matrix seems to be an important factor that may affect the bioavailability of cocoa polyphenols. For instance, proteins in the food matrix are supposed to form highly polymerized complexes with procyanidins, which can reduce bioaccessibility of these phenolic compounds. However, the potential negative effect of protein content in foods was not confirmed in a study that evaluated the cocoa polyphenols bioavailability after the intake of a milk-powder cocoa beverage. However, concurrent carbohydrates consumption seems to increase significantly the uptake of flavonols in humans. Little is known whether and to what extent oligomeric procyanidins from cocoa are absorbed. However, the biological activity of procyanidins with high polymerization degree may be partly attributed to their colonic breakdown products, including phenolic acids.
Actually there is also a growing interest in other biological properties of phenolic compounds in addition to their antioxidant effects; particularly, some evidences suggest that certain dietary phenols may modulate metabolic homeostasis. This is the case of chlorogenic acids, that are reported to play a potential role in modifying the pattern of intestinal glucose uptake and of other flavonoids (quercetin, catechins) that may modulate activation of GLP-1 receptor, involved in modulation of insulin and glucagon secretion, gastric emptying, and appetite.
In this randomized, crossover trial, serum, urine and fecal concentrations of curcumin and cocoa polyphenols, their parental compounds, metabolites and phenolic acids, following a two day multi-dose administration with six food sources, will be measured. All volunteers will undergo to six interventions - bread enriched with three different forms of curcumin (free, encapsulated, and encapsulated plus piperine) and nut based creams enriched with cocoa polyphenols (free or encapsulated one) or control cream (without enrichment). A one-week wash-out period will be included between two sequential treatments. Blood, urine and feces will be collected at time 0 (baseline), 24, and 48 hours; further blood samples at 0.5, 1, 2, 4, 6 hours after consumption of the first meal, and urine samples at 2 hours time intervals up to 10 hours, will be collected too. In particular, area under the curve (AUC) of serum and urine concentrations of parental compounds and metabolites in the time interval 0-24 hours will be calculated as primary outcomes. In addition the amount of total polyphenols in fecal samples will be measured.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| encapsulated curcumin | Experimental | Other: encapsulated curcumin |
| encapsulated curcumin + PQG | Experimental | Other: encapsulated curcumin + PQGPQG means Piperine, Quercetin and Genistein |
| free cocoa polyphenol | Active comparator | Other: free cocoa polyphenol |
| control | Placebo comparator | Other: control nut cream |
| encapsulated cocoa polyphenols | Experimental | Other: encapsulated cocoa polyphenols |
| free curcumin | Active comparator | Other: free curcuminSubjects will consume bread added with free curcumin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18 - 45 years old, male and female
- Healthy by medical assessment
- Normal weight: BMI 18 - 25
- Sign of a written informed consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| free curcuminfree curcumin in bread, dosage 1g/100g, 200g/day per 1 day | Other | free curcumin |
| encapsulated curcuminencapsulated curcumin-enriched bread, 1g/100g bread, 200g bread/day | Other | encapsulated curcumin |
| encapsulated curcumin + PQGbread enriched with encapsulated curcumin plus piperine, quercetin and genistein, 1g/100g bread, 200g bread/day | Other | encapsulated curcumin + PQG |
| free cocoa polyphenolnut cream enriched with free cocoa polyphenols, 1,5 g/100g cream, 100g/day per 1 day | Other | free cocoa polyphenol |
| encapsulated cocoa polyphenolsnut cream enriched with encapsulated cocoa polyphenols, 1,5 g/100g cream, 100g/day per 1 day | Other | encapsulated cocoa polyphenols |
| control nut creamnut cream, cocoa polyphenols 0g/100g cream, 100 g/day per 1 day | Other | control |
Primary outcome
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincenzo Fogliano, Professor principal investigator
University of Naples
Paola Vitaglione, Researcher study director
University of Naples
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing free curcumin, encapsulated curcumin and encapsulated curcumin + PQG in people with Healthy, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Polyphenol Concentrations Over 24h From Food Consumption (time frame: 0, 0.5, 1, 2, 4, 6, and 24 hours post-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2012.