DyslipidemiasCHOCO-dietNCT03850405
Dark Chocolate, Cholesterol and Microbiota
A study testing Dark Chocolate in people with Dyslipidemias and Hypertriglyceridemia, run by University of Bari at 1 site in Italy.
Trial summary
Scientific evidence shows that a major consume of flavonoids is associated with a minor risk of coronary disease and a modification of the gut microbiome profile. Dark chocolate has a major quantity of flavonoids by weight in comparison to wine, dark tea, blueberry juice, apples and, in particular the flavanols (i.e. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemias, Hypertriglyceridemia
- What is being tested?
- Dark Chocolate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2019to 1 Mar 2020
- 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals able to fill an Informed Consent
- Aged 40-60 years old with 1:1 matched criteria, age difference of ± 1 year old
- Patients with mild dyslipidemia (total cholesterol 201-250 mg/dL, LDL≥155 mg/dL) with or without hypertriglyceridemia (150-180 mg/dL) who accept to be inserted in a program aimed to reduce their caloric intake, including diet alone or diet plus chocolate
Who cannot join
- Missing Informed Consent
- Diagnosis of organic diseases, including neoplastic inflammatory diseases or cardiovascular diseases
- Patients on statin therapy
- Drugs which can affect the gastrointestinal tract and interfere with the symptoms
- Pregnancy
- Presence of diseases with a prognosis of less than 12 months
- Hypersensitivity to chocolate or chocolate components
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Biomedical Sciences Human Oncology - Clinica Medica "A. Murri"
Bari, BA, 70124
About this study
Official title: Effects of Dark Chocolate on Gut Microbiome and Cholesterol Reduction in Subjects With Moderate Dyslipidemia
Scientific evidence shows that a major consume of flavonoids is associated with a minor risk of coronary disease and a modification of the gut microbiome profile.
Dark chocolate has a major quantity of flavonoids by weight in comparison to wine, dark tea, blueberry juice, apples and, in particular the flavanols (i.e. catechin, epicatechin and procyanidin) can have protective and metabolic effects with reduction of the insulin resistance and improvement of the endothelial function in adults.
In line with the aforementioned evidence, the present study has the aim of analyze the effect of dark chocolate (70%) on cardiovascular risk and on the metabolism in a population with mild dyslipidemia.
Read the detailed description
Chocolate, the main product deriving from cocoa beans (Theobroma cacao, from the Greek "food of the gods") has its origin in Mexico, where Maya, Inca and Aztecs practiced their cultivation. For centuries, it has been appreciated for its pleasant taste and for its beneficial effects on health, and it is one of the most sought-after worldwide, with a consumption greatly increasing in recent years thanks to a wide availability of products on the market.
Dietary choices are strongly influenced by the taste and consistency of foods. Fat is largely responsible for the sensory properties of many foods and, therefore, contribute greatly to the pleasure of eating. Dark chocolate consists of ≈43% of lipids, mainly represented by cocoa butter, the latter consisting on average of 33% of oleic acid, 25% of palmitic acid and 33% of stearic acid. Another component of chocolate is polyphenols, in particular flavonoids, substances with numerous beneficial effects for health, including antihypertensive, anti-inflammatory, antithrombotic, metabolic and prebiotic activity, playing a role in the change of human intestinal microbiota.
Recent scientific studies show an inverse correlation between flavonoid intake in the diet and the incidence of diabetes, such as to hypothesize the use of flavonoid-rich foods as potential nutritional supplements in the management of diabetes. The cocoa flavonoids can bring benefits to the insulin-resistance condition by improving endothelial function, modifying glucose metabolism and reducing oxidative stress, which is considered the main cause of insulin resistance. In healthy individuals and patients with moderate cardiovascular risk, regular flavonoid intake improves levels of cardiovascular biomarkers, lowering serum LDL cholesterol and triglycerides and increasing HDL cholesterol. The flavonoids present in cocoa can also inhibit platelet aggregation by down-regulation of the cellular synthesis of eicosanoids.
- Conditions
- Dyslipidemias, Hypertriglyceridemia
- Being tested
- Dark Chocolate
- Medical subject headings
- Dyslipidemias, Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dark ChocolateDietary supplement
20 patients (10 male, 10 female) will undergo a diet containing 25g of dark chocolate (70%), corresponding to ca. 145 kcal which will be detracted from the total caloric intake.
| Study group | Role | What they receive |
|---|---|---|
| Chocolate | Experimental | 20 patients (matched per gender) undergoing a diet which includes 25g of dark chocolate (70%), i.e. ca. 145 kcal per day Receives: Dietary Supplement: Dark Chocolate |
| Control | No intervention | 20 patients (matched per gender) undergoing a low-fat dietary regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Cholesterol
Total cholesterol in mg/100ml will be measured by serum extraction from 3ml of whole peripheral blood.
Measured: Baseline
Triglycerides
Triglycerides in mg/dl will be measured by serum extraction from 3ml of whole peripheral blood.
Measured: Baseline
HDL Cholesterol
HDL Cholesterol in mg/dl will be measured by serum extraction from 3ml of whole peripheral blood.
Measured: Baseline
Counts of viable fecal bacterial cells
Estimate of microbial Shannon's (H') diversity from 3g faecal sample:
Heterotrophic aerobic and anaerobic bacteria Total anaerobes Lactic acid bacteria Lactobacillus Lactococcus and Streptococcus Staphylococcus Bacteroides Porphyromonas and Prevotella Enterobacteria Aeromonas and Pseudomonas Bifidobacterium Enterococci
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start1 May 2019 (estimated)
- Primary completion1 Jul 2019 (estimated)
- Study completion1 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiasStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, piero portincasa, University of Bari
- Investigators
- Piero Portincasa, MD, PhD, Principal investigator, Clinica Medica "A. Murri", DIMO - University of Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03850405
- Sponsor's protocol ID
- 1419UO
- Acronym
- CHOCO-diet
- Status last verified
- Apr 2019
- First submitted
- 11 Feb 2019
- Last updated
- 17 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Latif R. Chocolate/cocoa and human health: a review. Neth J Med. 2013 Mar;71(2):63-8.
PubMed 23462053Shah SR, Alweis R, Najim NI, Dharani AM, Jangda MA, Shahid M, Kazi AN, Shah SA. Use of dark chocolate for diabetic patients: a review of the literature and current evidence. J Community Hosp Intern Med Perspect. 2017 Sep 19;7(4):218-221. doi: 10.1080/20009666.2017.1361293. eCollection 2017 Oct.
PubMed 29181133Schroeter H, Heiss C, Balzer J, Kleinbongard P, Keen CL, Hollenberg NK, Sies H, Kwik-Uribe C, Schmitz HH, Kelm M. (-)-Epicatechin mediates beneficial effects of flavanol-rich cocoa on vascular function in humans. Proc Natl Acad Sci U S A. 2006 Jan 24;103(4):1024-9. doi: 10.1073/pnas.0510168103. Epub 2006 Jan 17.
PubMed 16418281Ueshima K. Magnesium and ischemic heart disease: a review of epidemiological, experimental, and clinical evidences. Magnes Res. 2005 Dec;18(4):275-84.
PubMed 16548143Allen RR, Carson L, Kwik-Uribe C, Evans EM, Erdman JW Jr. Daily consumption of a dark chocolate containing flavanols and added sterol esters affects cardiovascular risk factors in a normotensive population with elevated cholesterol. J Nutr. 2008 Apr;138(4):725-31. doi: 10.1093/jn/138.4.725.
PubMed 18356327Hayek N. Chocolate, gut microbiota, and human health. Front Pharmacol. 2013 Feb 7;4:11. doi: 10.3389/fphar.2013.00011. eCollection 2013. No abstract available.
PubMed 23405053Davinelli S, Corbi G, Righetti S, Sears B, Olarte HH, Grassi D, Scapagnini G. Cardioprotection by Cocoa Polyphenols and omega-3 Fatty Acids: A Disease-Prevention Perspective on Aging-Associated Cardiovascular Risk. J Med Food. 2018 Oct;21(10):1060-1069. doi: 10.1089/jmf.2018.0002. Epub 2018 May 3.
PubMed 29723102Lee Y, Berryman CE, West SG, Chen CO, Blumberg JB, Lapsley KG, Preston AG, Fleming JA, Kris-Etherton PM. Effects of Dark Chocolate and Almonds on Cardiovascular Risk Factors in Overweight and Obese Individuals: A Randomized Controlled-Feeding Trial. J Am Heart Assoc. 2017 Nov 29;6(12):e005162. doi: 10.1161/JAHA.116.005162.
PubMed 29187388
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dark Chocolate on Gut Microbiome and Cholesterol Reduction in Subjects With Moderate Dyslipidemia
- ClinicalTrials.gov ID
- NCT03850405
- Acronym / sponsor ID
- CHOCO-diet / 1419UO
- Conditions
- Dyslipidemias, Hypertriglyceridemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of BariUniversity, hospital or other
- Study start
- 1 May 2019 (estimated)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 21 Feb 2019 (actual)
- 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.
Scientific evidence shows that a major consume of flavonoids is associated with a minor risk of coronary disease and a modification of the gut microbiome profile.
Dark chocolate has a major quantity of flavonoids by weight in comparison to wine, dark tea, blueberry juice, apples and, in particular the flavanols (i.e. catechin, epicatechin and procyanidin) can have protective and metabolic effects with reduction of the insulin resistance and improvement of the endothelial function in adults.
In line with the aforementioned evidence, the present study has the aim of analyze the effect of dark chocolate (70%) on cardiovascular risk and on the metabolism in a population with mild dyslipidemia.
Detailed description
Chocolate, the main product deriving from cocoa beans (Theobroma cacao, from the Greek "food of the gods") has its origin in Mexico, where Maya, Inca and Aztecs practiced their cultivation. For centuries, it has been appreciated for its pleasant taste and for its beneficial effects on health, and it is one of the most sought-after worldwide, with a consumption greatly increasing in recent years thanks to a wide availability of products on the market.
Dietary choices are strongly influenced by the taste and consistency of foods. Fat is largely responsible for the sensory properties of many foods and, therefore, contribute greatly to the pleasure of eating. Dark chocolate consists of ≈43% of lipids, mainly represented by cocoa butter, the latter consisting on average of 33% of oleic acid, 25% of palmitic acid and 33% of stearic acid. Another component of chocolate is polyphenols, in particular flavonoids, substances with numerous beneficial effects for health, including antihypertensive, anti-inflammatory, antithrombotic, metabolic and prebiotic activity, playing a role in the change of human intestinal microbiota.
Recent scientific studies show an inverse correlation between flavonoid intake in the diet and the incidence of diabetes, such as to hypothesize the use of flavonoid-rich foods as potential nutritional supplements in the management of diabetes. The cocoa flavonoids can bring benefits to the insulin-resistance condition by improving endothelial function, modifying glucose metabolism and reducing oxidative stress, which is considered the main cause of insulin resistance. In healthy individuals and patients with moderate cardiovascular risk, regular flavonoid intake improves levels of cardiovascular biomarkers, lowering serum LDL cholesterol and triglycerides and increasing HDL cholesterol. The flavonoids present in cocoa can also inhibit platelet aggregation by down-regulation of the cellular synthesis of eicosanoids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chocolate | Experimental | Dietary Supplement: Dark Chocolate20 patients (matched per gender) undergoing a diet which includes 25g of dark chocolate (70%), i.e. ca. 145 kcal per day |
| Control | No intervention | –20 patients (matched per gender) undergoing a low-fat dietary regimen |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Individuals able to fill an Informed Consent
- Aged 40-60 years old with 1:1 matched criteria, age difference of ± 1 year old
- Patients with mild dyslipidemia (total cholesterol 201-250 mg/dL, LDL≥155 mg/dL) with or without hypertriglyceridemia (150-180 mg/dL) who accept to be inserted in a program aimed to reduce their caloric intake, including diet alone or diet plus chocolate
Key exclusion criteria (7 listed)
- Missing Informed Consent
- Diagnosis of organic diseases, including neoplastic inflammatory diseases or cardiovascular diseases
- Patients on statin therapy
- Drugs which can affect the gastrointestinal tract and interfere with the symptoms
- Pregnancy
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 |
|---|---|---|
| Dark Chocolate20 patients (10 male, 10 female) will undergo a diet containing 25g of dark chocolate (70%), corresponding to ca. 145 kcal which will be detracted from the total caloric intake. | Dietary supplement | Chocolate |
Primary outcome
Total Cholesterol
Time frame: Baseline
Total cholesterol in mg/100ml will be measured by serum extraction from 3ml of whole peripheral blood.
Triglycerides
Time frame: Baseline
Triglycerides in mg/dl will be measured by serum extraction from 3ml of whole peripheral blood.
HDL Cholesterol
Time frame: Baseline
HDL Cholesterol in mg/dl will be measured by serum extraction from 3ml of whole peripheral blood.
Counts of viable fecal bacterial cells
Time frame: Baseline
Estimate of microbial Shannon's (H') diversity from 3g faecal sample: Heterotrophic aerobic and anaerobic bacteria Total anaerobes Lactic acid bacteria Lactobacillus Lactococcus and Streptococcus Staphylococcus Bacteroides Porphyromonas and Prevotella Enterobacteria Aeromonas and Pseudomonas Bifidobacterium Enterococci
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Background: PubMed 23462053Latif R. Chocolate/cocoa and human health: a review. Neth J Med. 2013 Mar;71(2):63-8.
- Background: PubMed 29181133Shah SR, Alweis R, Najim NI, Dharani AM, Jangda MA, Shahid M, Kazi AN, Shah SA. Use of dark chocolate for diabetic patients: a review of the literature and current evidence. J Community Hosp Intern Med Perspect. 2017 Sep 19;7(4):218-221. doi: 10.1080/20009666.2017.1361293. eCollection 2017 Oct.
- Background: PubMed 16418281Schroeter H, Heiss C, Balzer J, Kleinbongard P, Keen CL, Hollenberg NK, Sies H, Kwik-Uribe C, Schmitz HH, Kelm M. (-)-Epicatechin mediates beneficial effects of flavanol-rich cocoa on vascular function in humans. Proc Natl Acad Sci U S A. 2006 Jan 24;103(4):1024-9. doi: 10.1073/pnas.0510168103. Epub 2006 Jan 17.
- Background: PubMed 16548143Ueshima K. Magnesium and ischemic heart disease: a review of epidemiological, experimental, and clinical evidences. Magnes Res. 2005 Dec;18(4):275-84.
- Background: PubMed 18356327Allen RR, Carson L, Kwik-Uribe C, Evans EM, Erdman JW Jr. Daily consumption of a dark chocolate containing flavanols and added sterol esters affects cardiovascular risk factors in a normotensive population with elevated cholesterol. J Nutr. 2008 Apr;138(4):725-31. doi: 10.1093/jn/138.4.725.
- Background: PubMed 23405053Hayek N. Chocolate, gut microbiota, and human health. Front Pharmacol. 2013 Feb 7;4:11. doi: 10.3389/fphar.2013.00011. eCollection 2013. No abstract available.
- Background: PubMed 29723102Davinelli S, Corbi G, Righetti S, Sears B, Olarte HH, Grassi D, Scapagnini G. Cardioprotection by Cocoa Polyphenols and omega-3 Fatty Acids: A Disease-Prevention Perspective on Aging-Associated Cardiovascular Risk. J Med Food. 2018 Oct;21(10):1060-1069. doi: 10.1089/jmf.2018.0002. Epub 2018 May 3.
- Background: PubMed 29187388Lee Y, Berryman CE, West SG, Chen CO, Blumberg JB, Lapsley KG, Preston AG, Fleming JA, Kris-Etherton PM. Effects of Dark Chocolate and Almonds on Cardiovascular Risk Factors in Overweight and Obese Individuals: A Randomized Controlled-Feeding Trial. J Am Heart Assoc. 2017 Nov 29;6(12):e005162. doi: 10.1161/JAHA.116.005162.
- Individual participant dataSharing planned: Undecided
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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.
Piero Portincasa, MD, PhD principal investigator
Clinica Medica "A. Murri", DIMO - University of Bari
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dark Chocolate in people with Dyslipidemias and Hypertriglyceridemia, run by University of Bari at 1 site in Italy.
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: status not confirmed, as of the sponsor's last update on 17 Apr 2019. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Piero Portincasa, MD, PhD (+393284687215, piero.portincasa@uniba.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Cholesterol (time frame: Baseline). The study lists 4 primary outcomes in all. 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 NCT03850405, which also lists 8 linked publications.
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 Apr 2019.