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Genetic and Epigenetic Mechanisms Underlying Cocoa Health Benefits

NCT ID: NCT02292576

Last Updated: 2014-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-08-31

Brief Summary

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

Detailed Description

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

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Acute dose/Chronic dose

Acute dose/Chronic dose.

Group Type EXPERIMENTAL

Cocoa Pure

Intervention Type OTHER

Cocoa Pure.

Placebo

Intervention Type OTHER

Placebo.

Chronic dose/Acute dose

Chronic dose/Acute dose.

Group Type EXPERIMENTAL

Cocoa Pure

Intervention Type OTHER

Cocoa Pure.

Placebo

Intervention Type OTHER

Placebo.

Interventions

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Cocoa Pure

Cocoa Pure.

Intervention Type OTHER

Placebo

Placebo.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria Elizabeth Tejero Barrera, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Medicina Genomica

Other Identifiers

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11.21.NRC

Identifier Type: -

Identifier Source: org_study_id