Genetic and Epigenetic Mechanisms Underlying Cocoa Health Benefits

November 14, 2014 updated by: Nestlé
Evaluate if gene expression changes in SOD2 explain the health benefits of high polyphenols cocoa

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acute dose/Chronic dose
Acute dose/Chronic dose.
Other: Cocoa Pure
Cocoa Pure.
Other: Placebo
Placebo.
Experimental: Chronic dose/Acute dose
Chronic dose/Acute dose.
Other: Cocoa Pure
Cocoa Pure.
Other: Placebo
Placebo.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Determination of DNA methylation pattern in the chronic phase of the study
Time Frame: After 4 weeks of chronic dose
After 4 weeks of chronic dose
Evaluation of (-)epicatechin bioavailability in plasma
Time Frame: After 4 weeks of chronic dose
After 4 weeks of chronic dose
Determination of plasma antioxidant capacity as a marker of oxidative stress
Time Frame: After 4 weeks of chronic dose
After 4 weeks of chronic dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nestlé

Investigators

  • Principal Investigator: Maria Elizabeth Tejero Barrera, Ph.D., Instituto Nacional de Medicina Genomica

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

November 12, 2014

First Submitted That Met QC Criteria

November 14, 2014

First Posted (Estimate)

November 17, 2014

Study Record Updates

Last Update Posted (Estimate)

November 17, 2014

Last Update Submitted That Met QC Criteria

November 14, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 11.21.NRC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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