HealthyNCT02292576
Genetic and Epigenetic Mechanisms Underlying Cocoa Health Benefits
A study testing Cocoa Pure in people with Healthy, run by Société des Produits Nestlé (SPN).
Trial summary
Evaluate if gene expression changes in SOD2 explain the health benefits of high polyphenols cocoa Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cocoa Pure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults
- BMI between 18.5 and 30 kg/m2
- Sedentary to moderate physical activity habits
Who cannot join
- 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
About this study
Evaluate if gene expression changes in SOD2 explain the health benefits of high polyphenols cocoa
Read the detailed description
Evaluate if gene expression changes in SOD2 explain the health benefits of high polyphenols cocoa.
- Conditions
- Healthy
- Being tested
- Cocoa Pure, Placebo
- Keywords
- volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cocoa PureOther
Cocoa Pure.
PlaceboOther
Placebo.
| Study group | Role | What they receive |
|---|---|---|
| Acute dose/Chronic dose | Experimental | Acute dose/Chronic dose. Receives: Other: Cocoa Pure; Other: Placebo |
| Chronic dose/Acute dose | Experimental | Chronic dose/Acute dose. Receives: Other: Cocoa Pure; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of changes in SOD2 gene expression
Measured: after acute dose and 4 weeks of chronic dose
Secondary outcomes (3)
Determination of DNA methylation pattern in the chronic phase of the study
Measured: After 4 weeks of chronic dose
Evaluation of (-)epicatechin bioavailability in plasma
Measured: After 4 weeks of chronic dose
Determination of plasma antioxidant capacity as a marker of oxidative stress
Measured: After 4 weeks of chronic dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2014 (estimated)
- Study startJun 2012
- Primary completionApr 2013
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria Elizabeth Tejero Barrera, Ph.D., Principal investigator, Instituto Nacional de Medicina Genomica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02292576
- Sponsor's protocol ID
- 11.21.NRC
- Status last verified
- Nov 2014
- First submitted
- 12 Nov 2014
- Last updated
- 17 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic and Epigenetic Mechanisms Underlying Cocoa Health Benefits
- ClinicalTrials.gov ID
- NCT02292576
- Acronym / sponsor ID
- 11.21.NRC
- Conditions
- Healthy
- Keywords
- volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 17 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute dose/Chronic dose | Experimental | Other: Cocoa Pure, Other: PlaceboAcute dose/Chronic dose. |
| Chronic dose/Acute dose | Experimental | Other: Cocoa Pure, Other: PlaceboChronic dose/Acute dose. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adults
- BMI between 18.5 and 30 kg/m2
- Sedentary to moderate physical activity habits
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cocoa PureCocoa Pure. | Other | Acute dose/Chronic dose, Chronic dose/Acute dose |
| PlaceboPlacebo. | Other | Acute dose/Chronic dose, Chronic dose/Acute dose |
Primary outcome
Measurement of changes in SOD2 gene expression
Time frame: after acute dose and 4 weeks of chronic dose
3 secondary outcomes
Determination of DNA methylation pattern in the chronic phase of the study
Time frame: After 4 weeks of chronic dose
Evaluation of (-)epicatechin bioavailability in plasma
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Elizabeth Tejero Barrera, Ph.D. principal investigator
Instituto Nacional de Medicina Genomica
Questions about this trial
What is this clinical trial studying?
A study testing Cocoa Pure in people with Healthy, run by Société des Produits Nestlé (SPN).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of changes in SOD2 gene expression (time frame: after acute dose and 4 weeks of chronic dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2014.