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Effect of Nutritional Intervention and Olive Oil in Severe Obesity

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ClinicalTrials.gov Identifier: NCT02463435
Recruitment Status : Completed
First Posted : June 4, 2015
Last Update Posted : April 7, 2016
Sponsor:
Collaborators:
Fundação de Amparo a Pesquisa do Estado de Goias (FAPEG)
Unidade de Pesquisa Clinica (UPC) do Hospital das Clínicas/UFG
Grupo de Estudos em Obesidade Grave (GEOG)
Information provided by (Responsible Party):
Ana Paula dos Santos Rodrigues, Universidade Federal de Goias

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.

Condition or disease Intervention/treatment Phase
Severe Obesity Behavioral: Nutritional intervention Other: Nutritional intervention plus olive oil Dietary Supplement: Olive oil Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 229 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Nutritional Intervention and Olive Oil in Severe Obesity: Randomized Controlled Trial
Study Start Date : June 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Olive oil

Arm Intervention/treatment
Active Comparator: Nutritional intervention
Patients under only nutritional intervention for weight loss
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.

Experimental: Nutritional intervention plus olive oil
Patients under conventional treatment (nutritional intervention) plus extra virgin olive oil supplementation
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.

Experimental: Olive oil
Patient under habitual food consumption plus extra virgin olive oil supplementation
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.




Primary Outcome Measures :
  1. Anthropometric measurements change [ Time Frame: Baseline, week 12 ]
    Measurements of weight, arm circumference and Body Mass Index (BMI) will be evaluated to assess anthropometric change.

  2. Body composition change [ Time Frame: Baseline, week 12 ]
    Body fat mass (BFM), body fat percentage (%BF) and body mass density (BMD) will be evaluated to assess body composition change. BFM and %BF will be assessed using multifrequency bioelectrical impedance analysis (BIA) and dual energy X-ray absorptiometry (DXA) and BMD will be assessed using DXA.


Secondary Outcome Measures :
  1. Change in inflammation parameters [ Time Frame: Baseline, week 12 ]
    TNF-alfa, interleucin 6 (IL6), IL1, IL10, adiponectin, C-reactive protein (CRP)

  2. Change in metabolic parameters [ Time Frame: Baseline, week 12 ]
    Lipid profile (total cholesterol, LDL-c, HDL-c, VLDL-c), insulin resistance (HOMA-IR, glycated hemoglobin), fasting glycaemia, hemogram

  3. Change in kidney function [ Time Frame: Baseline, week 12 ]
    Creatinine, urea and uric acid

  4. Change in liver function [ Time Frame: Baseline, week 12 ]
    AST and ALT

  5. Change in thyroid function [ Time Frame: Baseline, week 12 ]
    TSH, T4 and parathyroid hormone

  6. Change in vitamins [ Time Frame: Baseline, week 12 ]
    Vitamin D, vitamin B12 and folic acid

  7. Change in minerals [ Time Frame: Baseline, week 12 ]
    Iron, calcium, sodium, potassium and zinc

  8. Change in cardiovascular risk using Global Risk Score (GRS) [ Time Frame: Baseline, week 12 ]
  9. Change in cardiovascular risk using Framingham Risk Score (FRS) [ Time Frame: Baseline, week 12 ]
  10. Change in cardiovascular risk using heart rate variability (HRV) [ Time Frame: Baseline, week 12 ]
  11. Change in cardiovascular risk using Homocystein level [ Time Frame: Baseline, week 12 ]
  12. Polymorphism Pro12Ala of Peroxisome Proliferator-Activated Receptor Alfa (PPAR-alfa) [ Time Frame: Baseline, week12 ]
    Difference in responses between intervention groups for anthropometric measurements (weight, arm circumference and body mass index) and body composition variables (body fat mass and body fat percentage) according to this polymorphism

  13. PolymorphismTrp64Arg of Beta-3 Adrenergic Receptor (ADRB3) gene [ Time Frame: Baseline, week12 ]
    Difference in responses between intervention groups for anthropometric measurements (weight, arm circumference and body mass index) and body composition variables (body fat mass and body fat percentage) according to this polymorphism

  14. Polymorphism -174G>C of Interleukin 6 (IL6) gene. [ Time Frame: Baseline, week12 ]
    Difference in responses between intervention groups for anthropometric measurements (weight, arm circumference and body mass index) and body composition variables (body fat mass and body fat percentage) according to this polymorphism

  15. Change in physical activity practice using Global Physical Activity Questionnaire [ Time Frame: Baseline, week 12 ]
  16. Change in physical activity practice using accelerometry [ Time Frame: Baseline, week 12 ]
  17. Change in food intake using Food Frequency Questionnaire [ Time Frame: Baseline, week 12 ]
  18. Change in food intake using 24 hour recall [ Time Frame: Baseline, week 12 ]
  19. Change in bone health parameters [ Time Frame: Baseline, week 12 ]
    Change in the following variables: bone density using DXA, falls and fractures and sun exposure

  20. Change in obesity sarcopenia using muscle mass (evaluated using DXA) [ Time Frame: Baseline, week 12 ]
  21. Change in obesity sarcopenia using handgrip strength [ Time Frame: Baseline, week 12 ]
  22. Change in sarcopenia using usual gait speed [ Time Frame: Baseline, week 12 ]
  23. Adherence to nutritional intervention [ Time Frame: Baseline, week 12 ]
    It will be evaluated through changes in food consumption (food frequency questionnaire)

  24. Adherence to the health service [ Time Frame: Baseline, week 12 ]
    It will be evaluated through attendance to the clinic visits

  25. Change in symptoms of anxiety and depression using Hospital Anxiety and Depression Scale [ Time Frame: Baseline, week 12 ]
  26. Change in symptoms of binge eating disorderusing Binge Eating Disorder Scale [ Time Frame: Baseline, week 12 ]
  27. Change in musculoskeletal pain using Visual Analog Scale [ Time Frame: Baseline, week 12 ]
  28. Change in musculoskeletal pain using Nordic Musculoskeletal Questionnaire [ Time Frame: Baseline, week 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02463435


Locations
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Brazil
Unidade de Pesquisa Clínica do Hospital das Clínicas/UFG
Goiânia, Goiás, Brazil, 74605-020
Sponsors and Collaborators
Universidade Federal de Goias
Fundação de Amparo a Pesquisa do Estado de Goias (FAPEG)
Unidade de Pesquisa Clinica (UPC) do Hospital das Clínicas/UFG
Grupo de Estudos em Obesidade Grave (GEOG)
Investigators
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Study Director: Erika A Silveira, PhD Universidade Federal de Goias - Faculdade de Medicina
Principal Investigator: Ana Paula S Rodrigues, MsC Universidade Federal de Goias - Faculdade de Medicina
Principal Investigator: Jacqueline D Souza, MsC Universidade Federal de Goias - Faculdade de Medicina
Principal Investigator: Camila KS Cardoso, MsC Universidade Federal de Goias - Faculdade de Medicina
Principal Investigator: Lorena PS Rosa, MsC Universidade Federal de Goias - Faculdade de Medicina
Principal Investigator: Annelisa SA Santos, MsC Universidade Federal de Goias - Faculdade de Medicina
Principal Investigator: Andrea BS Canheta, MsC Universidade Federal de Goias - Faculdade de Medicina
Principal Investigator: Carolina R Mendonça, MsC Universidade Federal de Goias - Faculdade de Medicina

Publications:
Sposito AC, Caramelli B, Fonseca FA, Bertolami MC, Afiune Neto A, Souza AD, Lottenberg AM, Chacra AP, Faludi AA, Loures-Vale AA, Carvalho AC, Duncan B, Gelonese B, Polanczyk C, Rodrigues Sobrinho CR, Scherr C, Karla C, Armaganijan D, Moriguchi E, Saraiva F, Pichetti G, Xavier HT, Chaves H, Borges JL, Diament J, Guimarães JI, Nicolau JC, dos Santos JE, de Lima JJ, Vieira JL, Novazzi JP, Faria Neto JR, Torres KP, Pinto Lde A, Bricarello L, Bodanese LC, Introcaso L, Malachias MV, Izar MC, Magalhães ME, Schmidt MI, Scartezini M, Nobre M, Foppa M, Forti NA, Berwanger O, Gebara OC, Coelho OR, Maranhão RC, dos Santos Filho RD, Costa RP, Barreto S, Kaiser S, Ihara S, Carvalho Td, Martinez TL, Relvas WG, Salgado W; Sociedade Brasileira de Cardiologia. [IV Brazilian Guideline for Dyslipidemia and Atherosclerosis prevention: Department of Atherosclerosis of Brazilian Society of Cardiology]. Arq Bras Cardiol. 2007 Apr;88 Suppl 1:2-19. Portuguese.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ana Paula dos Santos Rodrigues, Master in Nutrition and Health, Universidade Federal de Goias
ClinicalTrials.gov Identifier: NCT02463435     History of Changes
Other Study ID Numbers: 747.792
First Posted: June 4, 2015    Key Record Dates
Last Update Posted: April 7, 2016
Last Verified: April 2016
Keywords provided by Ana Paula dos Santos Rodrigues, Universidade Federal de Goias:
nutritional management
olive oil
weight loss
body composition
nutrigenomics
polymorphisms
cardiovascular risk
sarcopenia
inflammation
food intake
sedentary lifestyle
patient adherence
bone density
Additional relevant MeSH terms:
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Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms