Effect of Nutritional Intervention and Olive Oil in Severe Obesity

Severe Obesity Clinical Trial

Official title:

Effect of Nutritional Intervention and Olive Oil in Severe Obesity: Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02463435
• Other study ID #: 747.792
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: February 2016

Study information

• Verified date: November 2020
• Source: Universidade Federal de Goias
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 229
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Obesity, Morbid
• Severe Obesity

Intervention

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.

Locations

Country	Name	City	State
Brazil	Unidade de Pesquisa Clínica do Hospital das Clínicas/UFG	Goiânia	Goiás

Sponsors (4)

Lead Sponsor	Collaborator
Universidade Federal de Goias	Fundação de Amparo a Pesquisa do Estado de Goias (FAPEG), Grupo de Estudos em Obesidade Grave (GEOG), Unidade de Pesquisa Clinica (UPC) do Hospital das Clínicas/UFG

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

Hill JO, Wyatt HR, Peters JC. Energy balance and obesity. Circulation. 2012 Jul 3;126(1):126-32. doi: 10.1161/CIRCULATIONAHA.111.087213. Review. — View 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. — View Citation

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. — View 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. Erratum in: J Am Diet Assoc. 2003 May;103(5):563. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anthropometric measurements change	Measurements of weight, arm circumference and Body Mass Index (BMI) will be evaluated to assess anthropometric change.	Baseline, week 12
Primary	Body composition change	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.	Baseline, week 12
Secondary	Change in inflammation parameters	TNF-alfa	Baseline, week 12
Secondary	Change in inflammation parameters	Interleucin 6 (IL6), IL1, IL10	Baseline, week 12
Secondary	Change in inflammation parameters	Adiponectin	Baseline, week 12
Secondary	Change in inflammation parameters	C-reactive protein (CRP)	Baseline, week 12
Secondary	Change in inflammation parameters	Neutrophil to lymphocyte ratio (NLR) and lymphocyte to monocyte ratio (LMR)	Baseline, week 12
Secondary	Change in metabolic parameters	Lipid profile (total cholesterol, LDL-c, HDL-c, VLDL-c), insulin resistance (HOMA-IR, glycated hemoglobin), fasting glycaemia, hemogram	Baseline, week 12
Secondary	Change in kidney function	Creatinine, urea and uric acid	Baseline, week 12
Secondary	Change in liver function	AST and ALT	Baseline, week 12
Secondary	Change in thyroid function	TSH, T4 and parathyroid hormone	Baseline, week 12
Secondary	Change in vitamins	Vitamin D, vitamin B12 and folic acid	Baseline, week 12
Secondary	Change in minerals	Iron, calcium, sodium, potassium and zinc	Baseline, week 12
Secondary	Change in cardiovascular risk using Global Risk Score (GRS)		Baseline, week 12
Secondary	Change in cardiovascular risk using Framingham Risk Score (FRS)		Baseline, week 12
Secondary	Change in cardiovascular risk using heart rate variability (HRV)		Baseline, week 12
Secondary	Change in cardiovascular risk using Homocystein level		Baseline, week 12
Secondary	Polymorphism Pro12Ala of Peroxisome Proliferator-Activated Receptor Alfa (PPAR-alfa)	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	Baseline, week12
Secondary	PolymorphismTrp64Arg of Beta-3 Adrenergic Receptor (ADRB3) gene	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	Baseline, week12
Secondary	Polymorphism -174G>C of Interleukin 6 (IL6) gene.	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	Baseline, week12
Secondary	Change in physical activity practice using Global Physical Activity Questionnaire		Baseline, week 12
Secondary	Change in physical activity practice using accelerometry		Baseline, week 12
Secondary	Change in food intake using Food Frequency Questionnaire		Baseline, week 12
Secondary	Change in food intake using 24 hour recall		Baseline, week 12
Secondary	Change in bone health parameters	Change in the following variables: bone density using DXA, falls and fractures and sun exposure	Baseline, week 12
Secondary	Change in obesity sarcopenia using muscle mass (evaluated using DXA)		Baseline, week 12
Secondary	Change in obesity sarcopenia using handgrip strength		Baseline, week 12
Secondary	Change in sarcopenia using usual gait speed		Baseline, week 12
Secondary	Adherence to nutritional intervention	It will be evaluated through changes in food consumption (food frequency questionnaire)	Baseline, week 12
Secondary	Adherence to the health service	It will be evaluated through attendance to the clinic visits	Baseline, week 12
Secondary	Change in symptoms of anxiety and depression using Hospital Anxiety and Depression Scale		Baseline, week 12
Secondary	Change in symptoms of binge eating disorderusing Binge Eating Disorder Scale		Baseline, week 12
Secondary	Change in musculoskeletal pain using Visual Analog Scale		Baseline, week 12
Secondary	Change in musculoskeletal pain using Nordic Musculoskeletal Questionnaire		Baseline, week 12