Clinical trial NCT02463435: Effect of Nutritional Intervention and Olive Oil in Severe Obesity
Official title: Effect of Nutritional Intervention and Olive Oil in Severe Obesity: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Obesity
Keywords: nutritional management
olive oil
weight loss
body composition
nutrigenomics
polymorphisms
cardiovascular risk
sarcopenia
inflammation
food intake
sedentary lifestyle
patient adherence
bone density
Lead sponsor: Universidade Federal de Goias
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo a Pesquisa do Estado de Goias (FAPEG)
name: Unidade de Pesquisa Clinica (UPC) do Hospital das Clínicas/UFG
name: Grupo de Estudos em Obesidade Grave (GEOG)
First posted: 2015-06-04
Enrollment: 229
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: After enrollment, patients undergo a diagnostic phase (baseline) with nutritional, anthropometric and body composition assessment (multifrequency bioelectrical impedance analysis and dual X-ray absorptiometry); investigation of clinical history; collecting blood samples; carotid artery intima-media thickness, heart rate variability and accelerometry assessments; and application of validated questionnaires to evaluate secondary outcomes. Patients will be randomized into three different treatment groups. Randomization will be stratified according to Body Mass Index (BMI) (BMI between 35 and 39,99 kg/m2 and BMI ≥ 40 kg/m2), allocation ratio 1:1:1 and parallel intervention. Then, trained nutritionists will deliver the intervention according to the patient group and they will be followed-up for 12 weeks, with visits each 4 weeks.

Interventions will be provided as follow:

Olive oil group: in order to evaluate the effect of only the extra virgin olive oil on primary and secondary outcomes, patients will be instructed to maintain habitual food consumption and consume 52 mL of extra virgin olive oil daily (4 sachets per day, 2 at lunch and 2 at dinner).

Nutritional intervention group: patients assigned to this group will receive nutritional intervention consisting 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. Resting Energy Expenditure (REE) will be calculated according to Horie-Waitzberg \& Gonzalez equation developed for severe obese individual using current weight and lean body mass (Horie et al., 2011). Total energy expenditure (TEE) will be calculated multiplying REE by activity factor recommended by Institute of Medicine (Trumbo et al., 2005) and thermic effect of food (Hill, Wyat, Peters, 2012). Total energy value (TEV) of diet will be determined reducing 550 to 1100 kcal from TEE to reach 0.5 to 1.0 weekly weight reduction according to the patient's individual goal. Distribution of macronutrients will follow Dietary Reference Intake (DRI) recommendation: 45-65% of carbohydrates, 10-35% of proteins and 20-35% of lipids (Trumbo et al., 2002). Fat acids (FA) will be distributed as recommended by Sociedade Brasileira de Cardiologia (Sposito et al., 2007): ≤ 7% saturated FA, ≤ 20% monounsaturated FA and ≤ 7% polyunsaturated FA. Food plan prescription will distribute TEV in 4-6 meals. Motivation will be held to changing eating and lifestyle habits.

Nutritional intervention plus olive oil: this group will receive conventional intervention plus supplementation of 52 mL of extra virgin olive oil daily (4 sachets per day, 2 at lunch and 2 at dinner).

At the end of follow-up the same assessments performed at diagnostic phase will be held.

To detect a reduction of 10 kg, with standard deviation of 30, which is in agreement with the study of Rodrigues e Silveira (2011), with a two-sided 5% significance level and a power of 80%, a sample size of 50 patients per group will be necessary, given an anticipated dropout rate of 42,9%.

This research will be conducted at a capital of center Brazil, at Unidade de Pesquisa Clínica of Hospital das Clínica/UFG, Faculty of Medicine/UFG.

Eligibility criteria: Inclusion Criteria:

* Body mass index ≥ 35 kg/m2
* Residence in Goiânia or metropolitan area
* Patients referred by Secretaria Municipal de Saúde to Severe Obese Nutrition Clinic

Exclusion Criteria:

* To have already performed bariatric surgery
* Pregnancy
* Reduction greater than 8% of body weight in the past 3 months
* To have been treated at Severe Obesity Nutrition Clinic or have received nutritional counseling in another place in the last 2 years
* Anti-obesity drugs use
* Regular utilization of anti-inflammatory drugs or corticosteroids
* HIV/AIDS, heart failure, kidney failure, hepatic insufficiency, chronic obstructive pulmonary disease and cancer

Primary outcomes:
measure: Anthropometric measurements change
timeFrame: Baseline, week 12
measure: Body composition change
timeFrame: Baseline, week 12
Secondary outcomes:
measure: Change in inflammation parameters
timeFrame: Baseline, week 12
measure: Change in inflammation parameters
timeFrame: Baseline, week 12
measure: Change in inflammation parameters
timeFrame: Baseline, week 12
measure: Change in inflammation parameters
timeFrame: Baseline, week 12
measure: Change in inflammation parameters
timeFrame: Baseline, week 12
measure: Change in metabolic parameters
timeFrame: Baseline, week 12
measure: Change in kidney function
timeFrame: Baseline, week 12
measure: Change in liver function
timeFrame: Baseline, week 12
measure: Change in thyroid function
timeFrame: Baseline, week 12
measure: Change in vitamins
timeFrame: Baseline, week 12
measure: Change in minerals
timeFrame: Baseline, week 12
measure: Change in cardiovascular risk using Global Risk Score (GRS)
timeFrame: Baseline, week 12
measure: Change in cardiovascular risk using Framingham Risk Score (FRS)
timeFrame: Baseline, week 12
measure: Change in cardiovascular risk using heart rate variability (HRV)
timeFrame: Baseline, week 12
measure: Change in cardiovascular risk using Homocystein level
timeFrame: Baseline, week 12
measure: Polymorphism Pro12Ala of Peroxisome Proliferator-Activated Receptor Alfa (PPAR-alfa)
timeFrame: Baseline, week12
measure: PolymorphismTrp64Arg of Beta-3 Adrenergic Receptor (ADRB3) gene
timeFrame: Baseline, week12
measure: Polymorphism -174G>C of Interleukin 6 (IL6) gene.
timeFrame: Baseline, week12
measure: Change in physical activity practice using Global Physical Activity Questionnaire
timeFrame: Baseline, week 12
measure: Change in physical activity practice using accelerometry
timeFrame: Baseline, week 12
measure: Change in food intake using Food Frequency Questionnaire
timeFrame: Baseline, week 12
measure: Change in food intake using 24 hour recall
timeFrame: Baseline, week 12
measure: Change in bone health parameters
timeFrame: Baseline, week 12
measure: Change in obesity sarcopenia using muscle mass (evaluated using DXA)
timeFrame: Baseline, week 12
measure: Change in obesity sarcopenia using handgrip strength
timeFrame: Baseline, week 12
measure: Change in sarcopenia using usual gait speed
timeFrame: Baseline, week 12
measure: Adherence to nutritional intervention
timeFrame: Baseline, week 12
measure: Adherence to the health service
timeFrame: Baseline, week 12
measure: Change in symptoms of anxiety and depression using Hospital Anxiety and Depression Scale
timeFrame: Baseline, week 12
measure: Change in symptoms of binge eating disorderusing Binge Eating Disorder Scale
timeFrame: Baseline, week 12
measure: Change in musculoskeletal pain using Visual Analog Scale
timeFrame: Baseline, week 12
measure: Change in musculoskeletal pain using Nordic Musculoskeletal Questionnaire
timeFrame: Baseline, week 12
Other outcomes:
Locations:
city: Goiânia
country: Brazil
facility: Unidade de Pesquisa Clínica do Hospital das Clínicas/UFG
state: Goiás
Study officials:
affiliation: Universidade Federal de Goias - Faculdade de Medicina
name: Erika A Silveira, PhD
role: STUDY_DIRECTOR
affiliation: Universidade Federal de Goias - Faculdade de Medicina
name: Ana Paula S Rodrigues, MsC
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Federal de Goias - Faculdade de Medicina
name: Jacqueline D Souza, MsC
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Federal de Goias - Faculdade de Medicina
name: Camila KS Cardoso, MsC
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Federal de Goias - Faculdade de Medicina
name: Lorena PS Rosa, MsC
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Federal de Goias - Faculdade de Medicina
name: Annelisa SA Santos, MsC
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Federal de Goias - Faculdade de Medicina
name: Andrea BS Canheta, MsC
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Federal de Goias - Faculdade de Medicina
name: Carolina R Mendonça, MsC
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Horie LM, Gonzalez MC, Torrinhas RS, Cecconello I, Waitzberg DL. New specific equation to estimate resting energy expenditure in severely obese patients. Obesity (Silver Spring). 2011 May;19(5):1090-4. doi: 10.1038/oby.2010.326. Epub 2011 Jan 13.
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citation: Trumbo P, Schlicker S, Yates AA, Poos M; Food and Nutrition Board of the Institute of Medicine, The National Academies. Dietary reference intakes for energy, carbohydrate, fiber, fat, fatty acids, cholesterol, protein and amino acids. J Am Diet Assoc. 2002 Nov;102(11):1621-30. doi: 10.1016/s0002-8223(02)90346-9. No abstract available.
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citation: Longhi R, Santos ASEAC, Lopez-Yerena A, Rodrigues APS, Oliveira C, Silveira EA. The Effectiveness of Extra Virgin Olive Oil and the Traditional Brazilian Diet in Reducing the Inflammatory Profile of Individuals with Severe Obesity: A Randomized Clinical Trial. Nutrients. 2021 Nov 19;13(11):4139. doi: 10.3390/nu13114139.
citation: Kellen de Souza Cardoso C, Gondim Peixoto MDR, Dos Santos Rodrigues AP, Rodrigues Mendonca C, de Oliveira C, Aparecida Silveira E. Bone Mineral Density in Severely Obese Women: Health Risk and Health Protective Risk Factors in Three Different Bone Sites. Int J Environ Res Public Health. 2020 Sep 25;17(19):7017. doi: 10.3390/ijerph17197017.
citation: Canheta ABS, Santos ASEAC, Souza JD, Silveira EA. Traditional Brazilian diet and extra virgin olive oil reduce symptoms of anxiety and depression in individuals with severe obesity: Randomized clinical trial. Clin Nutr. 2021 Feb;40(2):404-411. doi: 10.1016/j.clnu.2020.05.046. Epub 2020 Jun 10.
citation: Aparecida Silveira E, Danesio de Souza J, Dos Santos Rodrigues AP, Lima RM, de Souza Cardoso CK, de Oliveira C. Effects of Extra Virgin Olive Oil (EVOO) and the Traditional Brazilian Diet on Sarcopenia in Severe Obesity: A Randomized Clinical Trial. Nutrients. 2020 May 21;12(5):1498. doi: 10.3390/nu12051498.
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