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A Mediterranean-style Breakfast and Postprandial Lipid Disorders in Obese Pre-adolescents and Adults

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Mediterranean-style breakfast
Western-style breakfast
Sponsored by
National Research Council, Spain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Obesity, Adolescence, Lipid metabolism, Mediterranean diet, Chylomicron, Macrophages

Eligibility Criteria

11 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adolescents below 15 years-old with BMI ≥ 30 and above the 95 percentile for their gender and age.
  • No history of psychiatric or organic disease, except for obesity.
  • Appropriate cultural level to understand the study.
  • A written informed consent of their parents or tutors.

Exclusion Criteria:

  • Subjects being treated with drugs for any kind of disease.
  • Those suffering of chronic diseases.
  • A negative to participate in the study from them or their parents or tutors.
  • Subjects having participated in another clinical study the preceding 3 months.

Sites / Locations

  • Instituto de la Grasa (IG-CSIC)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Mediterranean-style breakfast

Western-style breakfast

Arm Description

Outcomes

Primary Outcome Measures

Delay in plasma triglyceride and CM clearance in obese pre-adolescents
It is expected to find a delay in plasma triglyceride and CM clearance in obese pre-adolescents, and to find more atherogenic features in CM and CMR in this group. These characteristics include changes in the lipid and protein composition of lipoproteins. It is expected to define the CM and CMR concentration in the blood of obese pre-adolescents, using as marker the presence of apo B48 in these particles. Particle size and lipid composition will show to what extent CM and CMR are more or less atherogenic in pre-adolescents and obese adults.

Secondary Outcome Measures

Differences in the composition and structure of the plasma membrane in obese volunteers
We expect to find changes in the composition and structure of the plasma membrane in obese volunteers, which could be related to increased blood pressure. For the first time, we will unravel the molecular species composition of plasma membrane phospholipids of obese pre-adolescents, which will be a milestone in the study of the physiological implications of obesity in this population.

Full Information

First Posted
January 23, 2012
Last Updated
September 20, 2016
Sponsor
National Research Council, Spain
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1. Study Identification

Unique Protocol Identification Number
NCT01518803
Brief Title
A Mediterranean-style Breakfast and Postprandial Lipid Disorders in Obese Pre-adolescents and Adults
Official Title
Influence of a Mediterranean-style Breakfast on Postprandial Lipid Disorders and Inflammatory Processes in Obese Pre-adolescents and Adults
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Research Council, Spain

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Obesity has a major impact on the development of cardiovascular disease and other related conditions and it is of particular concern in children. The prevalence of childhood overweight and obesity in Spain is among the highest in the European continent. Childhood obesity has been associated with diseases that were thought to apply only to adults, such as the metabolic syndrome. Insulin resistance is the most important risk factor in subjects with severe obesity, which together with visceral obesity, exacerbates postprandial triglyceridemia, increasing cardiovascular risk. In this context, the investigators hypothesize that the postprandial lipid metabolism is also impaired in obese pre-adolescents, as it is in obese adults. This includes not only exacerbated postprandial triglyceridemia, but also impaired levels of inflammation markers. In addition, the investigators hypothesize that the lipid and protein composition of postprandial chylomicrons and chylomicron remnants are also altered in obese children when compared with their normal-weight counterparts, and that these postprandial lipoproteins induce foam cell formation differently. The investigators also believe that a Mediterranean-style meal can help to normalize the altered postprandial lipid metabolism in obese adolescents.
Detailed Description
Excess of body weight has led the World Health Organization to call it a global epidemic. Obesity has a major impact on the development of cardiovascular disease and other related conditions and it is of particular concern in children. The prevalence of childhood overweight and obesity in Spain is among the highest in the European continent. The health consequences of obesity in children are not as evident as in adults, but childhood obesity has been associated with diseases that were thought to apply only to adults, such as the metabolic syndrome. Insulin resistance is the most important risk factor in subjects with severe obesity, which together with visceral obesity, exacerbates postprandial triglyceridemia, increasing cardiovascular risk. However, this has not been appropriately studied in children for the moment. The excellent results of previous projects carried out by our research group have shown the beneficial properties of olive oil on health, being the main ingredient of the Mediterranean Diet, including an improved postprandial lipid pattern. In this context, our hypothesis is that the postprandial lipid metabolism is also impaired in obese pre-adolescents, as it is in obese adults. This includes not only exacerbated postprandial triglyceridemia, but also impaired levels of inflammation markers. In addition, we hypothesize that the lipid and protein composition of postprandial chylomicrons and chylomicron remnants are also altered in obese children when compared with their normal-weight counterparts, and that these postprandial lipoproteins induce foam cell formation differently, as well as a different release of inflammation markers by macrophages. However, it is also part of our hypothesis, that a Mediterranean-style meal,administrated as a breakfast can help to normalize the altered postprandial lipid metabolism in obese children. With this aim, we will carry out a dietary intervention study with a randomized, crossover design in a single meal, in order to measure changes in the postprandial lipid metabolism in pre-adolescents and adults affected by obesity and to compare the effect of a Mediterranean-style breakfast. Chylomicron remnants will be isolated from blood serum and will be fully characterized. These particles will be incubated with monocyte cell lines to determine their effect on cellular lipid metabolism and the production of inflammatory factors. In addition, the influence of obesity in the composition and structure of the plasma membrane will also be assessed. The results will generate knowledge about the pathophysiology of obesity in children and will contribute to the dietary recommendations for weight maintenance in this population. Furthermore, it will provide information on the development of atherosclerosis during the postprandial period, which may begin at very young ages.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Adolescence, Lipid metabolism, Mediterranean diet, Chylomicron, Macrophages

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mediterranean-style breakfast
Arm Type
Active Comparator
Arm Title
Western-style breakfast
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Mediterranean-style breakfast
Intervention Description
The experimental meal will be administered early in the morning as breakfast, "Cardioliva" olive oil, bread (2 slices), tomatoes (half piece), fruit juice (200 mL), skim milk (150 mL). The amount of fat administered will be the equivalent to 0.75 g per kg of body weight.
Intervention Type
Dietary Supplement
Intervention Name(s)
Western-style breakfast
Intervention Description
The experimental meal will be administered early in the morning as breakfast, containing butter, bread 82 slices), chocolate milk (200 mL). The amount of fat administered will be the equivalent to 0.75 g per kg of body weight.
Primary Outcome Measure Information:
Title
Delay in plasma triglyceride and CM clearance in obese pre-adolescents
Description
It is expected to find a delay in plasma triglyceride and CM clearance in obese pre-adolescents, and to find more atherogenic features in CM and CMR in this group. These characteristics include changes in the lipid and protein composition of lipoproteins. It is expected to define the CM and CMR concentration in the blood of obese pre-adolescents, using as marker the presence of apo B48 in these particles. Particle size and lipid composition will show to what extent CM and CMR are more or less atherogenic in pre-adolescents and obese adults.
Time Frame
2 and 4 hours postprandially
Secondary Outcome Measure Information:
Title
Differences in the composition and structure of the plasma membrane in obese volunteers
Description
We expect to find changes in the composition and structure of the plasma membrane in obese volunteers, which could be related to increased blood pressure. For the first time, we will unravel the molecular species composition of plasma membrane phospholipids of obese pre-adolescents, which will be a milestone in the study of the physiological implications of obesity in this population.
Time Frame
Time 0, baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adolescents below 15 years-old with BMI ≥ 30 and above the 95 percentile for their gender and age. No history of psychiatric or organic disease, except for obesity. Appropriate cultural level to understand the study. A written informed consent of their parents or tutors. Exclusion Criteria: Subjects being treated with drugs for any kind of disease. Those suffering of chronic diseases. A negative to participate in the study from them or their parents or tutors. Subjects having participated in another clinical study the preceding 3 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javier S Perona, PhD
Organizational Affiliation
National Research Council, Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto de la Grasa (IG-CSIC)
City
Seville
ZIP/Postal Code
41012
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
21519776
Citation
Aguilar Cordero MJ, Gonzalez Jimenez E, Sanchez Perona J, Padilla Lopez CA, Alvarez Ferre J, Mur Villar N, Rivas Garcia F. [The Guadix study of the effects of a Mediterranean-diet breakfast on the postprandial lipid parameters of overweight and obese pre-adolescents]. Nutr Hosp. 2010 Nov-Dec;25(6):1025-33. Spanish.
Results Reference
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A Mediterranean-style Breakfast and Postprandial Lipid Disorders in Obese Pre-adolescents and Adults

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