Genetic and Epigenetic Mechanisms Underlying Cocoa Health Benefits

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Cocoa Pure; Other: Placebo

• Registration Number: NCT02292576
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Study Timeline

• Study Start: 2012-06
• Primary Completion: 2013-04
• Study Completion: 2014-08
• Status Verified: 2014-11
• Study First Submitted: 2014-11-12
• Study First Submitted QC: 2014-11-14
• Last Update Submitted: 2014-11-14
• Study First Posted: 2014-11-17
• Last Update Posted: 2014-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Chronic dose/Acute dose	Cocoa Pure	Chronic dose/Acute dose.
Acute dose/Chronic dose	Cocoa Pure	Acute dose/Chronic dose.
Acute dose/Chronic dose	Placebo	Acute dose/Chronic dose.
Chronic dose/Acute dose	Placebo	Chronic dose/Acute dose.

Primary Outcome Measures

Name	Time	Method
Measurement of changes in SOD2 gene expression	after acute dose and 4 weeks of chronic dose

Secondary Outcome Measures

Name	Time	Method
Determination of plasma antioxidant capacity as a marker of oxidative stress	After 4 weeks of chronic dose
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