Lipid PeroxidationNCT01347450
Protective Effects of Cocoa Ingestion Over Healthy Males Plasma Lipids Subjected to Peroxidative Conditions
A study testing Cocoa powder berverage, dark chocolate bar in people with Lipid Peroxidation, run by Fundación Santa Fe de Bogota at 1 site in Colombia.
Trial summary
Background: Cocoa is rich in flavonoids such as (-)-epicatechin and (+)-catechin; these compounds have displayed both in vitro and in vivo antioxidant activity. Objective: This trial evaluate the regular ingestion effect of both, dark chocolate and cocoa powder, over plasma lipids of young males subjected to ex vivo… Read more about this study
- Who is it for?
- Ages 20 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Lipid Peroxidation
- What is being tested?
- Cocoa powder berverage, dark chocolate bar
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 1 siteColombia
- Study dates
- Oct 2007to Aug 2008
- 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 20 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal lipid profile
- Age between 20 and 30 years old
- Must like chocolate
Who cannot join
- Diagnosed coronary artery disease
- Diabetes mellitus
- Hypertension
- Use of any prescribed medication
- Restrictive diets and any
- Migraine or
- Cocoa products allergic antecedents
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Fundación Santa Fe de Bogotá, Universidad Industrial de Santander.
Bogotá DC., Bogotá DC.
About this study
Background: Cocoa is rich in flavonoids such as (-)-epicatechin and (+)-catechin; these compounds have displayed both in vitro and in vivo antioxidant activity.
Objective: This trial evaluate the regular ingestion effect of both, dark chocolate and cocoa powder, over plasma lipids of young males subjected to ex vivo lipid peroxidative conditions.
Design: Single-blind, controlled and randomized clinical trial including 100 healthy men, divided into two groups: 50 subjects received 30 g of cocoa powder and 50 g of dark chocolate/d for 1 wk, and the other 50 subjects received placebo.
Read the detailed description
Adult young males were enrolled at the Universidad Industrial de Santander by publicity at the university food service centre. Those who respond (n=136) were selected after the normal blood lipid profile was verified by laboratory testing of total cholesterol, LDL, HDL, VLDL and triacylglycerols, as well exclusion and inclusion criteria were applied. Within the exclusion criteria we included diagnosed coronary artery disease, diabetes mellitus, arterial hypertension, use of any prescribed medication, restrictive diets and any migraine or cocoa products allergic antecedents.
Finally enlisted subjects were 120 non-smokers, normolipemic, ages were between 20 and 30 years old, who underwent anthropometric measurements like weight, height, BMI (among 16.0 and 27.4 kg/m2) and regular nutritional and toxicological habits using standardized surveys. Subjects received 3 meals a day from the Food Nutritional Service of Universidad Industrial de Santander, in order to ensure the same diet conditions for all subjects along the experimental period. An average colombian diet, based on 2287 calories as a total caloric value (protein 15%, fats 35% and carbohydrates 60%) was used. The study protocol and the informed consent were approved by the Fundación Santa Fe de Bogotá Institutional Ethical Committee (Santa Fe de Bogotá D.C., Colombia). We got written informed consent from all participants and they received money compensation for its participation in the study.
Outcome measures:
Susceptibility of plasma lipids to oxidation Determination of plasma lipids oxidation resistance Determination of oxidative protection
- Conditions
- Lipid Peroxidation
- Being tested
- Cocoa powder berverage, dark chocolate bar, Placebo
- Keywords
- Flavonoids, cacao, lipid peroxidation, plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cocoa powder berverage, dark chocolate barDietary supplement
Sugar drink containing 30 g of cocoa powder and 50 g of a 65% dark chocolate, and the control group received 30 g of placebo drink containing 0 g of cocoa powder. Each drink was prepared by using 300 ml of water and 30 g of sugar, also were consumed twice each day: with breakfast and afternoon meal. during 7-d after the intervention started.
PlaceboDietary supplement
Sugar drink containing 30 g of cocoa powder and 50 g of a 65% dark chocolate, and the control group received 30 g of placebo drink containing 0 g of cocoa powder. Each drink was prepared by using 300 ml of water and 30 g of sugar, also were consumed twice each day: with breakfast and afternoon meal. during 7-d after the intervention started.
| Study group | Role | What they receive |
|---|---|---|
| Cocoa, Placebo | Experimental | Not described Receives: Dietary Supplement: Cocoa powder berverage, dark chocolate bar; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxidative protection index
Oxidative protection of plasma lipids was set up by measuring hexanal, known as one of the main components of oxidizing n-6 polyunsaturated fatty acids (PUFA). The oxidative protection index (OPI), was defined as the difference between the basal and post intervention (cocoa taking in) sample chromatographic areas as stated by the formula: OPI = (Area0 - Area1/ Area0)*100. Hexanal determination was carried out by HS-SPME in situ derivatization method using PFPH fibre saturation as derivatizing agent under the methodology
Measured: 7-days after the intervention started.
Secondary outcomes (1)
Oxidation resistance index (ORI)
ORI was expressed as a percentage and held as the difference among basal (0) and post interventions (1) lag time of each subject according to the following formula: ORI = (lag1 - lag0/ lag1)*100. Plasma was 50-fold diluted in a saline phosphate solution (PBS; 0.0027M KCl, 0.137M NaCl, pH 7.4) and then was exposed to copper (II) chloride at final concentration of 95 µM in a 2.5 ml quartz cuvette. Conjugated diene formation from lipid peroxidation was followed at 245 nm wavelength, recorded each 5 min over 4-h period at 37ºC in a Perkin Elmer Lambda Bio 10 spectrophotometer
Measured: 7-days after the intervention started
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2011 (estimated)
- Study startOct 2007
- Primary completionJul 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lipid PeroxidationStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Santa Fe de Bogota
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
- Investigators
- Gabriel Carrasquilla, PhD, Study director, Fundación Santa Fe de Bogotá
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01347450
- Sponsor's protocol ID
- 20114
- Status last verified
- Sep 2004
- First submitted
- 29 Apr 2011
- Last updated
- 4 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Barrios M, Orozco LC, Stashenko EE. Cocoa ingestion protects plasma lipids in healthy males against ex vivo oxidative conditions: A randomized clinical trial. Clin Nutr ESPEN. 2018 Aug;26:1-7. doi: 10.1016/j.clnesp.2018.05.001. Epub 2018 May 30.
PubMed 29908675
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Effects of Cocoa Ingestion Over Healthy Males Plasma Lipids Subjected to Peroxidative Conditions
- ClinicalTrials.gov ID
- NCT01347450
- Acronym / sponsor ID
- 20114
- Conditions
- Lipid Peroxidation
- Keywords
- Flavonoids, cacao, lipid peroxidation, plasma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Fundación Santa Fe de BogotaUniversity, hospital or other
- Collaborators
- Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
- Study start
- Oct 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 4 May 2011 (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.
Background: Cocoa is rich in flavonoids such as (-)-epicatechin and (+)-catechin; these compounds have displayed both in vitro and in vivo antioxidant activity.
Objective: This trial evaluate the regular ingestion effect of both, dark chocolate and cocoa powder, over plasma lipids of young males subjected to ex vivo lipid peroxidative conditions.
Design: Single-blind, controlled and randomized clinical trial including 100 healthy men, divided into two groups: 50 subjects received 30 g of cocoa powder and 50 g of dark chocolate/d for 1 wk, and the other 50 subjects received placebo.
Detailed description
Adult young males were enrolled at the Universidad Industrial de Santander by publicity at the university food service centre. Those who respond (n=136) were selected after the normal blood lipid profile was verified by laboratory testing of total cholesterol, LDL, HDL, VLDL and triacylglycerols, as well exclusion and inclusion criteria were applied. Within the exclusion criteria we included diagnosed coronary artery disease, diabetes mellitus, arterial hypertension, use of any prescribed medication, restrictive diets and any migraine or cocoa products allergic antecedents.
Finally enlisted subjects were 120 non-smokers, normolipemic, ages were between 20 and 30 years old, who underwent anthropometric measurements like weight, height, BMI (among 16.0 and 27.4 kg/m2) and regular nutritional and toxicological habits using standardized surveys. Subjects received 3 meals a day from the Food Nutritional Service of Universidad Industrial de Santander, in order to ensure the same diet conditions for all subjects along the experimental period. An average colombian diet, based on 2287 calories as a total caloric value (protein 15%, fats 35% and carbohydrates 60%) was used. The study protocol and the informed consent were approved by the Fundación Santa Fe de Bogotá Institutional Ethical Committee (Santa Fe de Bogotá D.C., Colombia). We got written informed consent from all participants and they received money compensation for its participation in the study.
Outcome measures:
Susceptibility of plasma lipids to oxidation Determination of plasma lipids oxidation resistance Determination of oxidative protection
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cocoa, Placebo | Experimental | Dietary Supplement: Cocoa powder berverage, dark chocolate bar, Dietary Supplement: Placebo |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Normal lipid profile
- Age between 20 and 30 years old
- Must like chocolate
Key exclusion criteria (7 listed)
- Diagnosed coronary artery disease
- Diabetes mellitus
- Hypertension
- Use of any prescribed medication
- Restrictive diets and any
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 powder berverage, dark chocolate barSugar drink containing 30 g of cocoa powder and 50 g of a 65% dark chocolate, and the control group received 30 g of placebo drink containing 0 g of cocoa powder. Each drink was prepared by using 300 ml of water and 30 g of sugar, also were consumed twice each day: with breakfast and afternoon meal. during 7-d after the intervention started. | Dietary supplement | Cocoa, Placebo |
| PlaceboSugar drink containing 30 g of cocoa powder and 50 g of a 65% dark chocolate, and the control group received 30 g of placebo drink containing 0 g of cocoa powder. Each drink was prepared by using 300 ml of water and 30 g of sugar, also were consumed twice each day: with breakfast and afternoon meal. during 7-d after the intervention started. | Dietary supplement | Cocoa, Placebo |
Primary outcome
Oxidative protection index
Time frame: 7-days after the intervention started.
Oxidative protection of plasma lipids was set up by measuring hexanal, known as one of the main components of oxidizing n-6 polyunsaturated fatty acids (PUFA). The oxidative protection index (OPI), was defined as the difference between the basal and post intervention (cocoa taking in) sample chromatographic areas as stated by the formula: OPI = (Area0 - Area1/ Area0)*100. Hexanal determination was carried out by HS-SPME in situ derivatization method using PFPH fibre saturation as derivatizing agent under the methodology
1 secondary outcome
Oxidation resistance index (ORI)
Time frame: 7-days after the intervention started
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 4 May 2011.
- Derived from this study: PubMed 29908675Barrios M, Orozco LC, Stashenko EE. Cocoa ingestion protects plasma lipids in healthy males against ex vivo oxidative conditions: A randomized clinical trial. Clin Nutr ESPEN. 2018 Aug;26:1-7. doi: 10.1016/j.clnesp.2018.05.001. Epub 2018 May 30.
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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.
Gabriel Carrasquilla, PhD study director
Fundación Santa Fe de Bogotá
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cocoa powder berverage, dark chocolate bar in people with Lipid Peroxidation, run by Fundación Santa Fe de Bogota at 1 site in Colombia.
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 4 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Oxidative protection index (time frame: 7-days after the intervention started.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01347450, which also lists 1 linked publication.
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 4 May 2011.