Functional Goat Cheese Effect in Lipid Profile Change

NCT02630602 | Completed Phase 4 DMC

• 1 other identifier: LODYN 4092
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity and Overweight

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (5)

• change from baseline Triglycerides

  0 and 12 weeks

• change from baseline Apolipoprotein A1

  0 and 12 weeks

• change from baseline Apolipoprotein B

  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

Study Arms (2)

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

Dietary Supplement: Functional goat cheese

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

Dietary Supplement: Control cheese

Interventions

Functional goat cheese DIETARY_SUPPLEMENT

60 g per day during 12 weeks

Functional goat cheese

Control cheese DIETARY_SUPPLEMENT

60 g per day during 12 weeks

Control cheese

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead

Study Sites (1)

La Paz University Hospital

Madrid, Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Carmen Gomez, MD. PhD

  HOSPITAL LA PAZ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2015
• First Posted: December 15, 2015
• Study Start: March 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: December 15, 2015

Record last verified: 2015-12

Locations

ES (1)