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Functional Goat Cheese Effect in Lipid Profile Change (LODYN)

Primary Purpose

Obesity and Overweight

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Functional goat cheese
Control cheese
Sponsored by
Instituto de Investigación Hospital Universitario La Paz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity and Overweight

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • La Paz University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Functional goat cheese

Control cheese

Arm Description

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

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

Outcomes

Primary Outcome Measures

change from baseline total cholesterol
change from baseline Low density lipoprotein cholesterol
change from baseline High density lipoprotein cholesterol

Secondary Outcome Measures

change from baseline Triglycerides
change from baseline Apolipoprotein A1
change from baseline Apolipoprotein B
change from baseline Free fatty acids (FFA) in the plasma
change from baseline Erythrocyte membrane fatty acid composition

Full Information

First Posted
December 11, 2015
Last Updated
December 14, 2015
Sponsor
Instituto de Investigación Hospital Universitario La Paz
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1. Study Identification

Unique Protocol Identification Number
NCT02630602
Brief Title
Functional Goat Cheese Effect in Lipid Profile Change
Acronym
LODYN
Official Title
Functional Goat Cheese Effect in Lipid Profile Change
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigación Hospital Universitario La Paz

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity and Overweight

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Functional goat cheese
Arm Type
Active Comparator
Arm Description
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
Arm Title
Control cheese
Arm Type
Placebo Comparator
Arm Description
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 Type
Dietary Supplement
Intervention Name(s)
Functional goat cheese
Intervention Description
60 g per day during 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Control cheese
Intervention Description
60 g per day during 12 weeks
Primary Outcome Measure Information:
Title
change from baseline total cholesterol
Time Frame
0 and 12 weeks
Title
change from baseline Low density lipoprotein cholesterol
Time Frame
0 and 12 weeks
Title
change from baseline High density lipoprotein cholesterol
Time Frame
0 and 12 weeks
Secondary Outcome Measure Information:
Title
change from baseline Triglycerides
Time Frame
0 and 12 weeks
Title
change from baseline Apolipoprotein A1
Time Frame
0 and 12 weeks
Title
change from baseline Apolipoprotein B
Time Frame
0 and 12 weeks
Title
change from baseline Free fatty acids (FFA) in the plasma
Time Frame
0 and 12 weeks
Title
change from baseline Erythrocyte membrane fatty acid composition
Time Frame
0 and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen Gomez, MD. PhD
Organizational Affiliation
HOSPITAL LA PAZ
Official's Role
Principal Investigator
Facility Information:
Facility Name
La Paz University Hospital
City
Madrid
ZIP/Postal Code
28046
Country
Spain

12. IPD Sharing Statement

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Functional Goat Cheese Effect in Lipid Profile Change

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