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

NCT01518803 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2016-09-21

No results posted yet for this study

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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • National Research Council, Spain

    lead OTHER_GOV

Principal Investigators

  • Javier S Perona, PhD · National Research Council, Spain

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
11 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01518803 on ClinicalTrials.gov