NCT03850405

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 21, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

2 months

First QC Date

February 11, 2019

Last Update Submit

April 15, 2019

Conditions

DyslipidemiasHypertriglyceridemia

Outcome Measures

Primary Outcomes (4)

  • Total Cholesterol

    Total cholesterol in mg/100ml will be measured by serum extraction from 3ml of whole peripheral blood.

    Baseline

  • Triglycerides

    Triglycerides in mg/dl will be measured by serum extraction from 3ml of whole peripheral blood.

    Baseline

  • HDL Cholesterol

    HDL Cholesterol in mg/dl will be measured by serum extraction from 3ml of whole peripheral blood.

    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

    Baseline

Study Arms (2)

Chocolate

EXPERIMENTAL

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

Control

NO INTERVENTION

20 patients (matched per gender) undergoing a low-fat dietary regimen

Interventions

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.

Chocolate

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Biomedical Sciences Human Oncology - Clinica Medica "A. Murri"

Bari, BA, 70124, Italy

Location

Related Publications (8)

  • Latif R. Chocolate/cocoa and human health: a review. Neth J Med. 2013 Mar;71(2):63-8.

    PMID: 23462053BACKGROUND

  • Shah 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.

    PMID: 29181133BACKGROUND

  • Schroeter 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.

    PMID: 16418281BACKGROUND

  • Ueshima K. Magnesium and ischemic heart disease: a review of epidemiological, experimental, and clinical evidences. Magnes Res. 2005 Dec;18(4):275-84.

    PMID: 16548143BACKGROUND

  • Allen 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.

    PMID: 18356327BACKGROUND

  • Hayek 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.

    PMID: 23405053BACKGROUND

  • Davinelli 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.

    PMID: 29723102BACKGROUND

  • Lee 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.

    PMID: 29187388BACKGROUND

MeSH Terms

Conditions

DyslipidemiasHypertriglyceridemia

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperlipidemias

Study Officials

  • Piero Portincasa, MD, PhD

    Clinica Medica "A. Murri", DIMO - University of Bari

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Piero Portincasa, MD, PhD

CONTACT

+393284687215piero.portincasa@uniba.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine, Head Division of Internal Medicine

Study Record Dates

First Submitted

February 11, 2019

First Posted

February 21, 2019

Study Start

May 1, 2019

Primary Completion

July 1, 2019

Study Completion

March 1, 2020

Last Updated

April 17, 2019

Record last verified: 2019-04

Locations

IT(1)