Status:
UNKNOWN
Dark Chocolate, Cholesterol and Microbiota
Lead Sponsor:
University of Bari
Conditions:
Dyslipidemias
Hypertriglyceridemia
Eligibility:
All Genders
40-60 years
Phase:
NA
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 ...
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 centur...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03850405
Start Date
May 1 2019
End Date
March 1 2020
Last Update
April 17 2019
Active Locations (1)
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1
Department of Biomedical Sciences Human Oncology - Clinica Medica "A. Murri"
Bari, BA, Italy, 70124