Trial record 6 of 1905 for:    Lipid Storage Diseases

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2012 by National Research Council, Spain
Sponsor:
Information provided by (Responsible Party):
Javier Sánchez Perona, National Research Council, Spain
ClinicalTrials.gov Identifier:
NCT01518803
First received: January 23, 2012
Last updated: January 26, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Obesity
Dietary Supplement: Mediterranean-style breakfast
Dietary Supplement: Western-style breakfast

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Official Title: Influence of a Mediterranean-style Breakfast on Postprandial Lipid Disorders and Inflammatory Processes in Obese Pre-adolescents and Adults

Resource links provided by NLM:


Further study details as provided by National Research Council, Spain:

Primary Outcome Measures:
  • Delay in plasma triglyceride and CM clearance in obese pre-adolescents [ Time Frame: 2 and 4 hours postprandially ] [ Designated as safety issue: No ]
    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 [ Time Frame: Time 0, baseline ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 48
Study Start Date: May 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mediterranean-style breakfast Dietary Supplement: Mediterranean-style breakfast
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.
Active Comparator: Western-style breakfast Dietary Supplement: Western-style breakfast
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.

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.

  Eligibility

Ages Eligible for Study:   11 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01518803

Contacts
Contact: Javier S Perona, PhD +34954611550 ext 261 perona@ig.csic.es

Locations
Spain
Instituto de la Grasa (IG-CSIC) Recruiting
Seville, Spain, 41012
Contact: Javier S Perona, PhD    34954611550    perona@ig.csic.es   
Principal Investigator: Francisco Millán, PhD         
Sponsors and Collaborators
National Research Council, Spain
Investigators
Principal Investigator: Javier S Perona, PhD National Research Council, Spain
  More Information

Additional Information:
Publications:
Responsible Party: Javier Sánchez Perona, Tenured Scientist, National Research Council, Spain
ClinicalTrials.gov Identifier: NCT01518803     History of Changes
Other Study ID Numbers: AGL2011-23810
Study First Received: January 23, 2012
Last Updated: January 26, 2012
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by National Research Council, Spain:
Obesity
Adolescence
Lipid metabolism
Mediterranean diet
Chylomicron
Macrophages

Additional relevant MeSH terms:
Sphingolipidoses
Lipid Metabolism Disorders
Nutrition Disorders
Lysosomal Storage Diseases, Nervous System
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Lipidoses
Lipid Metabolism, Inborn Errors
Lysosomal Storage Diseases
Metabolic Diseases
Obesity
Overnutrition
Overweight
Body Weight
Signs and Symptoms
Metabolism, Inborn Errors

ClinicalTrials.gov processed this record on July 09, 2014