Functional Goat Cheese Effect in Lipid Profile Change (LODYN)

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

Tracking Information

• First Submitted Date: December 11, 2015
• First Posted Date: December 15, 2015
• Last Update Posted Date: December 15, 2015
• Study Start Date: March 2014
• Actual Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Functional Goat Cheese Effect in Lipid Profile Change
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Obesity and Overweight

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 14, 2015): 60
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: July 2014
• Actual Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT02630602
• Other Study ID Numbers: LODYN 4092
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Instituto de Investigación Hospital Universitario La Paz
• Study Sponsor: Instituto de Investigación Hospital Universitario La Paz
• Collaborators: Not Provided

Investigators

• Principal Investigator: Carmen Gomez, MD. PhD; HOSPITAL LA PAZ

• PRS Account: Instituto de Investigación Hospital Universitario La Paz
• Verification Date: December 2015