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Functional Goat Cheese Effect in Lipid Profile Change (LODYN)

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ClinicalTrials.gov Identifier: NCT02630602
Recruitment Status : Completed
First Posted : December 15, 2015
Last Update Posted : December 15, 2015
Sponsor:
Information provided by (Responsible Party):
Instituto de Investigación Hospital Universitario La Paz

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obesity and Overweight Dietary Supplement: Functional goat cheese Dietary Supplement: Control cheese Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Functional Goat Cheese Effect in Lipid Profile Change
Study Start Date : March 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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
 Dietary Supplement: Functional goat cheese
60 g per day during 12 weeks
Placebo Comparator: 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
 Dietary Supplement: Control cheese
60 g per day during 12 weeks


Outcome Measures
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Primary Outcome Measures :
  1. change from baseline total cholesterol [ Time Frame: 0 and 12 weeks ]
  2. change from baseline Low density lipoprotein cholesterol [ Time Frame: 0 and 12 weeks ]
  3. change from baseline High density lipoprotein cholesterol [ Time Frame: 0 and 12 weeks ]

Secondary Outcome Measures :
  1. change from baseline Triglycerides [ Time Frame: 0 and 12 weeks ]
  2. change from baseline Apolipoprotein A1 [ Time Frame: 0 and 12 weeks ]
  3. change from baseline Apolipoprotein B [ Time Frame: 0 and 12 weeks ]
  4. change from baseline Free fatty acids (FFA) in the plasma [ Time Frame: 0 and 12 weeks ]
  5. change from baseline Erythrocyte membrane fatty acid composition [ Time Frame: 0 and 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02630602


Locations
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Spain
La Paz University Hospital
Madrid, Spain, 28046
Sponsors and Collaborators
Instituto de Investigación Hospital Universitario La Paz
Investigators
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Principal Investigator: Carmen Gomez, MD. PhD HOSPITAL LA PAZ
More Information
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Responsible Party: Instituto de Investigación Hospital Universitario La Paz
ClinicalTrials.gov Identifier: NCT02630602    
Other Study ID Numbers: LODYN 4092
First Posted: December 15, 2015    Key Record Dates
Last Update Posted: December 15, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
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Overweight
Body Weight