Dark Chocolate, Cholesterol and Microbiota (CHOCO-diet)

April 15, 2019 updated by: piero portincasa, University of Bari

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • BA
      • Bari, BA, Italy, 70124
        • Department of Biomedical Sciences Human Oncology - Clinica Medica "A. Murri"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Cholesterol
Time Frame: Baseline
Total cholesterol in mg/100ml will be measured by serum extraction from 3ml of whole peripheral blood.
Baseline
Triglycerides
Time Frame: Baseline
Triglycerides in mg/dl will be measured by serum extraction from 3ml of whole peripheral blood.
Baseline
HDL Cholesterol
Time Frame: Baseline
HDL Cholesterol in mg/dl will be measured by serum extraction from 3ml of whole peripheral blood.
Baseline
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
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bari

Investigators

  • Principal Investigator: Piero Portincasa, MD, PhD, Clinica Medica "A. Murri", DIMO - University of Bari

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2019

Primary Completion (Anticipated)

July 1, 2019

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

February 11, 2019

First Submitted That Met QC Criteria

February 20, 2019

First Posted (Actual)

February 21, 2019

Study Record Updates

Last Update Posted (Actual)

April 17, 2019

Last Update Submitted That Met QC Criteria

April 15, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1419UO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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