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

NCT01518803 | Completed

• 1 other identifier: AGL2011-23810
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Obesity; Adolescence; Lipid metabolism; Mediterranean diet; Chylomicron; Macrophages

Outcome Measures

Primary Outcomes (1)

• 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.

  2 and 4 hours postprandially

Secondary Outcomes (1)

• Differences in the composition and structure of the plasma membrane in obese volunteers

  Time 0, baseline

Study Arms (2)

Mediterranean-style breakfast

ACTIVE COMPARATOR

Dietary Supplement: Mediterranean-style breakfast

Western-style breakfast

ACTIVE COMPARATOR

Dietary Supplement: Western-style breakfast

Interventions

Mediterranean-style breakfast DIETARY_SUPPLEMENT

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.

Mediterranean-style breakfast

Western-style breakfast DIETARY_SUPPLEMENT

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.

Western-style breakfast

Eligibility Criteria

• Age: 11 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Research Council, Spain: lead

Study Sites (1)

Instituto de la Grasa (IG-CSIC)

Seville, Seville, 41012, Spain

Location

Related Publications (1)

• 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.

  PMID: 21519776 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Javier S Perona, PhD

  National Research Council, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tenured Scientist

Study Record Dates

• First Submitted: January 23, 2012
• First Posted: January 26, 2012
• Study Start: May 1, 2010
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 21, 2016

Record last verified: 2016-09

Locations

ES (1)