Functional Goat Cheese Effect in Lipid Profile Change

Obesity and Overweight Clinical Trial

— LODYN  

Official title:

Functional Goat Cheese Effect in Lipid Profile Change

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02630602
• Other study ID #: LODYN 4092
• Status: Completed
• Phase: Phase 4
• First received: December 11, 2015
• Last updated: December 14, 2015
• Start date: March 2014
• Est. completion date: July 2014

Study information

• Verified date: December 2015
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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, ?-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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity and Overweight

Intervention

Dietary Supplement:
• Functional goat cheese
60 g per day during 12 weeks
• Control cheese
60 g per day during 12 weeks

Locations

Country	Name	City	State
Spain	La Paz University Hospital	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Hospital Universitario La Paz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline total cholesterol		0 and 12 weeks	Yes
Primary	change from baseline Low density lipoprotein cholesterol		0 and 12 weeks	Yes
Primary	change from baseline High density lipoprotein cholesterol		0 and 12 weeks	Yes
Secondary	change from baseline Triglycerides		0 and 12 weeks	Yes
Secondary	change from baseline Apolipoprotein A1		0 and 12 weeks	Yes
Secondary	change from baseline Apolipoprotein B		0 and 12 weeks	Yes
Secondary	change from baseline Free fatty acids (FFA) in the plasma		0 and 12 weeks	Yes
Secondary	change from baseline Erythrocyte membrane fatty acid composition		0 and 12 weeks	Yes