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Completed

NCT Number: NCT02630602

Functional Goat Cheese Effect in Lipid Profile Change

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

La Paz University Hospital

Madrid, 28046, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Functional goat cheese

Dietary Supplement

60 g per day during 12 weeks

Control cheese

Dietary Supplement

60 g per day during 12 weeks

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Hospital Universitario La Paz

Other

Registry information

Acronym: LODYN

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Dec 15, 2015
Registry last updated
Dec 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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