Genetic and Epigenetic Mechanisms Underlying Cocoa Health... | NCT02292576

Studies
Genetic and Epigenetic Mechanisms Underlying Cocoa Health Benefits

NCT02292576

Sponsor

Société des Produits Nestlé (SPN)

Status

Completed

Last Update Posted

Nov 17, 2014Estimated

Enrollment

50Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

Cocoa Pure
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Apr 2013Actual

Completion Date

Aug 2014Actual

First Submitted Date

Nov 12, 2014

First Submission Date that Met QC Criteria

Nov 14, 2014

First Posted Date

Nov 17, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 14, 2014

Last Update Posted Date

Nov 17, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Evaluate if gene expression changes in SOD2 explain the health benefits of high polyphenols cocoa

Detailed Description

Evaluate if gene expression changes in SOD2 explain the health benefits of high polyphenols cocoa.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Acute dose/Chronic dose	Experimental	Acute dose/Chronic dose.	Other: Cocoa Pure Other: Placebo
Chronic dose/Acute dose	Experimental	Chronic dose/Acute dose.	Other: Cocoa Pure Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cocoa Pure	Other	Cocoa Pure.	Acute dose/Chronic dose Chronic dose/Acute dose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measurement of changes in SOD2 gene expression		after acute dose and 4 weeks of chronic dose

Secondary Outcomes

Measure	Description	Time Frame
Determination of DNA methylation pattern in the chronic phase of the study		After 4 weeks of chronic dose
Evaluation of (-)epicatechin bioavailability in plasma		After 4 weeks of chronic dose

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy adults
BMI between 18.5 and 30 kg/m2
Sedentary to moderate physical activity habits

Exclusion Criteria:

Consumption of dietary supplements, antioxidants or anti-inflammatory medication, such as aspirin, ibuprofen, naproxen, or any medication that can affect the study outcomes
Actively smoking
Suspected abuse of alcohol or illicit drugs
Significant illness within two weeks prior to study start or any active systemic infection or medical condition that may require treatment or therapeutic intervention during the study
Subject who cannot be expected to comply with study procedures
Currently participating or having participated in another clinical trial during last 4 weeks prior to the beginning of this study
Consumption of chocolate or its derivates 24 hours before the blood sample taken

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Maria Elizabeth Tejero Barrera, Ph.D.	Instituto Nacional de Medicina Genomica	Principal Investigator

Locations

Not provided