NCT02292576

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 17, 2014

Completed
Last Updated

November 17, 2014

Status Verified

November 1, 2014

Enrollment Period

10 months

First QC Date

November 12, 2014

Last Update Submit

November 14, 2014

Conditions

Healthy

Keywords

volunteers

Outcome Measures

Primary Outcomes (1)

  • Measurement of changes in SOD2 gene expression

    after acute dose and 4 weeks of chronic dose

Secondary Outcomes (3)

  • 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

  • Determination of plasma antioxidant capacity as a marker of oxidative stress

    After 4 weeks of chronic dose

Study Arms (2)

Acute dose/Chronic dose

EXPERIMENTAL

Acute dose/Chronic dose.

Other: Cocoa PureOther: Placebo

Chronic dose/Acute dose

EXPERIMENTAL

Chronic dose/Acute dose.

Other: Cocoa PureOther: Placebo

Interventions

Cocoa PureOTHER

Cocoa Pure.

Acute dose/Chronic doseChronic dose/Acute dose
PlaceboOTHER

Placebo.

Acute dose/Chronic doseChronic dose/Acute dose

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Maria Elizabeth Tejero Barrera, Ph.D.

    Instituto Nacional de Medicina Genomica

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2014

First Posted

November 17, 2014

Study Start

June 1, 2012

Primary Completion

April 1, 2013

Study Completion

August 1, 2014

Last Updated

November 17, 2014

Record last verified: 2014-11