Effect of Nutritional Intervention and Olive Oil in Severe Obesity

NCT02463435 | Completed

• 1 other identifier: 747.792
• Study Type: interventional
• Target: 229
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Anthropometric measurements change

  Measurements of weight, arm circumference and Body Mass Index (BMI) will be evaluated to assess anthropometric change.

  Baseline, week 12

• 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 Outcomes (32)

• Change in inflammation parameters

  Baseline, week 12

• Change in inflammation parameters

  Baseline, week 12

• Change in inflammation parameters

  Baseline, week 12

• Change in inflammation parameters

  Baseline, week 12

• Change in inflammation parameters

  Baseline, week 12

Study Arms (3)

Nutritional intervention

ACTIVE COMPARATOR

Patients under only nutritional intervention for weight loss

Behavioral: Nutritional intervention

Nutritional intervention plus olive oil

EXPERIMENTAL

Patients under conventional treatment (nutritional intervention) plus extra virgin olive oil supplementation

Other: Nutritional intervention plus olive oil

Olive oil

EXPERIMENTAL

Patient under habitual food consumption plus extra virgin olive oil supplementation

Dietary Supplement: Olive oil

Interventions

Nutritional intervention BEHAVIORAL

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.

Nutritional intervention

Nutritional intervention plus olive oil OTHER

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.

Nutritional intervention plus olive oil

Olive oil DIETARY_SUPPLEMENT

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.

Olive oil

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal de Goias: lead
• Fundação de Amparo a Pesquisa do Estado de Goias (FAPEG): collaborator
• Unidade de Pesquisa Clinica (UPC) do Hospital das Clínicas/UFG: collaborator
• Grupo de Estudos em Obesidade Grave (GEOG): collaborator

Study Sites (1)

Unidade de Pesquisa Clínica do Hospital das Clínicas/UFG

Goiânia, Goiás, 74605-020, Brazil

Location

Related Publications (12)

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

  PMID: 22753534 BACKGROUND

• 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.

  PMID: 21233808 BACKGROUND

• 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, Guimaraes 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, Magalhaes ME, Schmidt MI, Scartezini M, Nobre M, Foppa M, Forti NA, Berwanger O, Gebara OC, Coelho OR, Maranhao 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. doi: 10.1590/s0066-782x2007000700002. No abstract available. Portuguese.

  PMID: 17515982 BACKGROUND

• 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.

  PMID: 12449285 BACKGROUND

• Rodrigues APDS, Batista SRR, Santos ASEA, Canheta ABS, Nunes BP, de Oliveira Rezende AT, de Oliveira C, Silveira EA. Multimorbidity and complex multimorbidity in Brazilians with severe obesity. Sci Rep. 2023 Oct 3;13(1):16629. doi: 10.1038/s41598-023-43545-5.

  PMID: 37789121 DERIVED

• Silveira EA, Rosa LPS, de Resende DP, Rodrigues APDS, da Costa AC, Rezende ATO, Noll M, de Oliveira C, Junqueira-Kipnis AP. Positive Effects of Extra-Virgin Olive Oil Supplementation and DietBra on Inflammation and Glycemic Profiles in Adults With Type 2 Diabetes and Class II/III Obesity: A Randomized Clinical Trial. Front Endocrinol (Lausanne). 2022 May 2;13:841971. doi: 10.3389/fendo.2022.841971. eCollection 2022.

  PMID: 35586621 DERIVED

• 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.

  PMID: 34836393 DERIVED

• 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.

  PMID: 32992832 DERIVED

• 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.

  PMID: 32675019 DERIVED

• 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.

  PMID: 32455620 DERIVED

• Cardoso CKS, Santos ASEAC, Rosa LPS, Mendonca CR, Vitorino PVO, Peixoto MDRG, Silveira EA. Effect of Extra Virgin Olive Oil and Traditional Brazilian Diet on the Bone Health Parameters of Severely Obese Adults: A Randomized Controlled Trial. Nutrients. 2020 Feb 4;12(2):403. doi: 10.3390/nu12020403.

  PMID: 32032997 DERIVED

• Rodrigues APS, Rosa LPS, Silveira EA. PPARG2 Pro12Ala polymorphism influences body composition changes in severely obese patients consuming extra virgin olive oil: a randomized clinical trial. Nutr Metab (Lond). 2018 Jul 17;15:52. doi: 10.1186/s12986-018-0289-4. eCollection 2018.

  PMID: 30026785 DERIVED

MeSH Terms

Conditions

Obesity, Morbid; Weight Loss; Sarcopenia; Inflammation; Sedentary Behavior; Patient Compliance

Interventions

Olive Oil

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathologic Processes; Behavior; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Erika A Silveira, PhD

  Universidade Federal de Goias - Faculdade de Medicina

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master in Nutrition and Health

Study Record Dates

• First Submitted: May 29, 2015
• First Posted: June 4, 2015
• Study Start: June 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: November 13, 2020

Record last verified: 2020-11

Locations

BR (1)