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The purpose this study was to evaluate the therapeutic effect of a functional goat cheese on obese and overweight people with altered lipid profile. The functional goat cheese containing polyunsaturated fatty acid, in amounts exceeding other cheese, was developed to benefit cardiovascular health of people who need to normalize lipid profile; which in the long term can contribute to the prevention of cardiovascular diseases.
A randomized, parallel, double-blind, controlled is being performing to evaluate the effect of a functional goat cheese on lipid profile in overweight or obese volunteers who need a special diet.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Functional goat cheese | Active Comparator | 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 |
|
| Control cheese | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Functional goat cheese | Dietary Supplement | 60 g per day during 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline total cholesterol | 0 and 12 weeks | |
| change from baseline Low density lipoprotein cholesterol | 0 and 12 weeks | |
| change from baseline High density lipoprotein cholesterol | 0 and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline Triglycerides | 0 and 12 weeks | |
| change from baseline Apolipoprotein A1 | 0 and 12 weeks | |
| change from baseline Apolipoprotein B |
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Inclusion Criteria:
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carmen Gomez, MD. PhD | HOSPITAL LA PAZ | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| La Paz University Hospital | Madrid | Madrid | 28046 | Spain |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Control cheese |
| Dietary Supplement |
60 g per day during 12 weeks |
|
| 0 and 12 weeks |
| change from baseline Free fatty acids (FFA) in the plasma | 0 and 12 weeks |
| change from baseline Erythrocyte membrane fatty acid composition | 0 and 12 weeks |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |