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Dark Chocolate, Cholesterol and Microbiota (CHOCO-diet)

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ClinicalTrials.gov Identifier: NCT03850405
Recruitment Status : Not yet recruiting
First Posted : February 21, 2019
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
piero portincasa, University of Bari

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Dyslipidemias Hypertriglyceridemia Dietary Supplement: Dark Chocolate Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Dark Chocolate on Gut Microbiome and Cholesterol Reduction in Subjects With Moderate Dyslipidemia
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Chocolate
20 patients (matched per gender) undergoing a diet which includes 25g of dark chocolate (70%), i.e. ca. 145 kcal per day
Dietary Supplement: Dark Chocolate
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.

No Intervention: Control
20 patients (matched per gender) undergoing a low-fat dietary regimen



Primary Outcome Measures :
  1. Total Cholesterol [ Time Frame: Baseline ]
    Total cholesterol in mg/100ml will be measured by serum extraction from 3ml of whole peripheral blood.

  2. Triglycerides [ Time Frame: Baseline ]
    Triglycerides in mg/dl will be measured by serum extraction from 3ml of whole peripheral blood.

  3. HDL Cholesterol [ Time Frame: Baseline ]
    HDL Cholesterol in mg/dl will be measured by serum extraction from 3ml of whole peripheral blood.

  4. 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




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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03850405


Contacts
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Contact: Piero Portincasa, MD, PhD +393284687215 piero.portincasa@uniba.it

Locations
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Italy
Department of Biomedical Sciences Human Oncology - Clinica Medica "A. Murri"
Bari, BA, Italy, 70124
Sponsors and Collaborators
University of Bari
Investigators
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Principal Investigator: Piero Portincasa, MD, PhD Clinica Medica "A. Murri", DIMO - University of Bari

Publications:

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Responsible Party: piero portincasa, Professor of Medicine, Head Division of Internal Medicine, University of Bari
ClinicalTrials.gov Identifier: NCT03850405     History of Changes
Other Study ID Numbers: 1419UO
First Posted: February 21, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dyslipidemias
Hypertriglyceridemia
Lipid Metabolism Disorders
Metabolic Diseases
Hyperlipidemias