Effect of Nutritional Intervention and Olive Oil in Severe Obesity

Summary

Obesity is a worldwide epidemic with increasing prevalence, specially severe obesity (Body Mass Index (BMI) ≥ 35 kg/m2). It is a multifactorial disease that involves genetic and environmental factors that lead to increased mortality from cardiovascular disease, diabetes, cancer, among others and impairs life quality. Most research on severe obesity focuses on surgical alternatives and their results, thus this clinical trial aims to evaluate the effect of a non-pharmacological approach based on nutritional intervention and supplementation with a functional food, the olive oil. It will analyze the effectiveness of interventions on: weight loss, improvements on body composition and inflammatory profile (TNF-alfa, interleucins 1, 6 and 10, adiponectin), insulin resistance and serum lipids control, changing eating habits and physical activity practice, modification on bone mineral density and sarcopenia, and reduction of cardiovascular risk and other diseases. Also, it will be investigated the influence of polymorphisms (Pro12Ala of PPAR-γ gene, -174G\>C of IL6 gene e Trp64Arg of ADRB3 gene) on nutritional intervention effectiveness with and without olive oil. This research looks for improving severely obese patient's care and contributing to effective results by reducing costs and risk treatment. The investigators believe that this informations will contribute significantly to the scientific field, expanding the knowledge about severe obesity.

Conditions

• Severe Obesity

Interventions

BEHAVIORAL

Nutritional intervention

Conventional treatment (Nutritional intervention) consists of prescription of individualized food plan to reduce 5 to 10% of initial body weight, nutritional counseling for comorbidities and promoting healthy eating habits and physical activity.

OTHER

Nutritional intervention plus olive oil

Nutritional intervention consists of prescription of individualized food plan to reduce 5 to 10% of initial body weight, nutritional counseling for comorbidities and promoting healthy eating habits and physical activity. Additionally, dietary supplementation with extra virgin olive oil (52 mL daily) will be held, divided in four (4) sachets per day, two (2) at lunch and two (2) at dinner.

DIETARY_SUPPLEMENT

Olive oil

Patients will be instructed to maintain habitual food consumption and consume 52 mL of extra virgin olive oil daily in four (4) sachets per day, two (2) at lunch and two (2) at dinner.

Sponsors & Collaborators

• Fundação de Amparo a Pesquisa do Estado de Goias (FAPEG)

  collaborator UNKNOWN

• Unidade de Pesquisa Clinica (UPC) do Hospital das Clínicas/UFG

  collaborator UNKNOWN

• Grupo de Estudos em Obesidade Grave (GEOG)

  collaborator UNKNOWN

• Universidade Federal de Goias

  lead OTHER

Principal Investigators

• Erika A Silveira, PhD · Universidade Federal de Goias - Faculdade de Medicina

• Ana Paula S Rodrigues, MsC · Universidade Federal de Goias - Faculdade de Medicina

• Jacqueline D Souza, MsC · Universidade Federal de Goias - Faculdade de Medicina

• Camila KS Cardoso, MsC · Universidade Federal de Goias - Faculdade de Medicina

• Lorena PS Rosa, MsC · Universidade Federal de Goias - Faculdade de Medicina

• Annelisa SA Santos, MsC · Universidade Federal de Goias - Faculdade de Medicina

• Andrea BS Canheta, MsC · Universidade Federal de Goias - Faculdade de Medicina

• Carolina R Mendonça, MsC · Universidade Federal de Goias - Faculdade de Medicina

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-06-30

Primary Completion

2016-02-29

Completion

2016-02-29

Countries

• Brazil

Study Locations