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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

Tracking Information
First Submitted Date  ICMJE December 11, 2015
First Posted Date  ICMJE December 15, 2015
Last Update Posted Date December 15, 2015
Study Start Date  ICMJE March 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 14, 2015)
  • change from baseline total cholesterol [ Time Frame: 0 and 12 weeks ]
  • change from baseline Low density lipoprotein cholesterol [ Time Frame: 0 and 12 weeks ]
  • change from baseline High density lipoprotein cholesterol [ Time Frame: 0 and 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2015)
  • change from baseline Triglycerides [ Time Frame: 0 and 12 weeks ]
  • change from baseline Apolipoprotein A1 [ Time Frame: 0 and 12 weeks ]
  • change from baseline Apolipoprotein B [ Time Frame: 0 and 12 weeks ]
  • change from baseline Free fatty acids (FFA) in the plasma [ Time Frame: 0 and 12 weeks ]
  • change from baseline Erythrocyte membrane fatty acid composition [ Time Frame: 0 and 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Functional Goat Cheese Effect in Lipid Profile Change
Official Title  ICMJE Functional Goat Cheese Effect in Lipid Profile Change
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Obesity and Overweight
Intervention  ICMJE
  • Dietary Supplement: Functional goat cheese
    60 g per day during 12 weeks
  • Dietary Supplement: Control cheese
    60 g per day during 12 weeks
Study Arms  ICMJE
  • 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
    Intervention: Dietary Supplement: Functional goat cheese
  • 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
    Intervention: Dietary Supplement: Control cheese
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 14, 2015)
60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02630602
Other Study ID Numbers  ICMJE LODYN 4092
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Instituto de Investigación Hospital Universitario La Paz
Study Sponsor  ICMJE Instituto de Investigación Hospital Universitario La Paz
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Carmen Gomez, MD. PhD HOSPITAL LA PAZ
PRS Account Instituto de Investigación Hospital Universitario La Paz
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP