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OpenTrials
Completed

NCT Number: NCT02292576

Genetic and Epigenetic Mechanisms Underlying Cocoa Health Benefits

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

Completed

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cocoa Pure

Other

Cocoa Pure.

Placebo

Other

Placebo.

Primary outcomes

  1. Measurement of changes in SOD2 gene expression

    Time frame: after acute dose and 4 weeks of chronic dose

Secondary outcomes

  1. Determination of DNA methylation pattern in the chronic phase of the study

    Time frame: After 4 weeks of chronic dose

  2. Evaluation of (-)epicatechin bioavailability in plasma

    Time frame: After 4 weeks of chronic dose

  3. Determination of plasma antioxidant capacity as a marker of oxidative stress

    Time frame: After 4 weeks of chronic dose

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Nov 17, 2014
Registry last updated
Nov 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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