Status:
UNKNOWN
Red-fleshed Apple as a Novel Anthocyanin-biofortified Food to Improve Cardiometabolic Risk Factors.
Lead Sponsor:
University Rovira i Virgili
Collaborating Sponsors:
Universitat de Lleida
Ministerio de Ciencia e Innovación, Spain
Conditions:
High LDL-cholesterol Levels
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary aim is to evaluate the added health value of the presence of anthocyanins in the redlove apple, versus a green apple with a similar matrix, on cardiometabolic risk, and compare the matrix ...
Detailed Description
The worldwide high prevalence of cardiovascular disease (CVD) requires lifestyle changes and new dietary prevention strategies based on the increased intake of foods rich in bioactive compounds, as th...
Eligibility Criteria
Inclusion
- Men and women over 18 years old.
- LDL-cholesterol levels ≥115 mg/dl and ≥190 mg/dl.
- Sign the informed consent provided before the initial screening visit.
Exclusion
- LDL-cholesterol levels ≤115 mg/dl and \<190 mg/dl.
- Use of hypolipemiant treatment (drugs and functional foods), or hypoglucaemiant treatment.
- Having diabetes mellitus type 1 or type 2.
- BMI values ≥35kg/m2.
- Present triglycerides levels ≥350mg/dl.
- Presenting anemia (hemoglobin ≤13g/dl in men and ≤12g/dl in women).
- Subjects diagnosed of intestinal disorders such as Chron disease, colitis ulcerous, celiac disease and irritable bowel syndrome.
- Present fructose and/or sorbitol and/or gluten intolerance.
- Present clinical active chronic disease
- Use of antioxidants supplements.
- Being pregnant or intending to become pregnant.
- Be in breastfeeding period.
- Present chronic alcoholism.
- Tobacco use.
- Participate in or have participated in a clinical trial or nutritional intervention study in the last 30 days prior to inclusion in the study.
- Being unable to follow the study guidelines.
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2020
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03795324
Start Date
January 1 2019
End Date
February 1 2020
Last Update
January 7 2019
Active Locations (1)
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1
University Rovira i Virgili
Reus, Tarragona, Spain