Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2014-03-31
2014-07-31
Brief Summary
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Detailed Description
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Were included 60 volunteers (men and women) aged between 18 and 65 years (IMC ≥27\<40 Kg/m2) with a cardiovascular risk (\<10%). The volunteers are being followed at La Paz University Hospital of Madrid. For 12 weeks, the volunteers should consume 60 g of cheese daily (functional cheese or control cheese) and to receive advice to follow a balanced and individualized hypocaloric diet as well as physical activity.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Functional goat cheese
The functional cheese is rich in conjugated linoleic acid (CLA) and omega-3. It was used for obese and overweight people, who need a special diet advice to control of lipid profile. 9,3% of polyunsaturated fatty acids 60 g per day during 12 weeks
Functional goat cheese
60 g per day during 12 weeks
Control cheese
Control cheese, not enriched with conjugated linoleic acid (CLA) and omega-3 4.1% of polyunsaturated fatty acids. 60 g per day during 12 weeks
Control cheese
60 g per day during 12 weeks
Interventions
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Functional goat cheese
60 g per day during 12 weeks
Control cheese
60 g per day during 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Cardiovascular risk \< 10% and almost two of follow factors:
Men ≥ 45 years old or women ≥ 55 years old; Familiar background of premature cardiovascular disease; HDL cholesterol \<40 mg/dL for men and \<50 mg/dL for women; Total cholesterol ≥ 200 mg/dL; Triglycerides ≥ 150 mg/dL and \< 200 mg/dL; LDL ≥ 130 mg/dL and \< 160 mg/dL; Smoker
* Accept advises to perform a balanced hypocaloric diet and regular practice of physical activity.
* Signed informed consent.
Exclusion Criteria
* Individuals with Diabetes Mellitus type 2, using medication;
* Individuals with Dyslipidemia, using drug;
* Individuals with high blood pressure, using medication;
* Individuals with allergies to dairy protein;
* Individuals with severe diseases (hepatic, kidney, cancer…);
* Individuals with drugs or supplements consumption to weight lost;
* Individuals that consume drugs, ω-3 supplements or supplement that can modify the lipid and / or glucose profile (statins, fibrates, diuretics, corticosteroids, insulin…);
* Individuals who have participated in programs and / or clinical trials of weight control in the last 6 months;
* Individuals with increased alcohol consumption 30g/day;
* Individuals that stop smoking in the next 20 weeks (during the study);
* Individuals with mental disease or low cognitive function;
* Pregnant women or breastfeeding;
* Individuals with intensive physical activity;
* Individuals with physical problems complying with the recommendations of physical activity and diet general recommendations.
18 Years
65 Years
ALL
No
Sponsors
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Instituto de Investigación Hospital Universitario La Paz
OTHER
Responsible Party
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Principal Investigators
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Carmen Gomez, MD. PhD
Role: PRINCIPAL_INVESTIGATOR
HOSPITAL LA PAZ
Locations
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La Paz University Hospital
Madrid, Madrid, Spain
Countries
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Other Identifiers
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LODYN 4092
Identifier Type: -
Identifier Source: org_study_id