Clinical trial NCT02630602: Functional Goat Cheese Effect in Lipid Profile Change
Official title: Functional Goat Cheese Effect in Lipid Profile Change
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity and Overweight
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2015-12-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Volunteers with overweight type II or obesity type I or II (IMC ≥27\<40 Kg/m2).
* 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 1;
* 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.

Primary outcomes:
measure: change from baseline total cholesterol
timeFrame: 0 and 12 weeks
measure: change from baseline Low density lipoprotein cholesterol
timeFrame: 0 and 12 weeks
measure: change from baseline High density lipoprotein cholesterol
timeFrame: 0 and 12 weeks
Secondary outcomes:
measure: change from baseline Triglycerides
timeFrame: 0 and 12 weeks
measure: change from baseline Apolipoprotein A1
timeFrame: 0 and 12 weeks
measure: change from baseline Apolipoprotein B
timeFrame: 0 and 12 weeks
measure: change from baseline Free fatty acids (FFA) in the plasma
timeFrame: 0 and 12 weeks
measure: change from baseline Erythrocyte membrane fatty acid composition
timeFrame: 0 and 12 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: La Paz University Hospital
Study officials:
affiliation: HOSPITAL LA PAZ
name: Carmen Gomez, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References: