Severe ObesityNCT02463435
Effect of Nutritional Intervention and Olive Oil in Severe Obesity
A study testing Nutritional intervention, Nutritional intervention plus olive oil and Olive oil in people with Severe Obesity, run by Universidade Federal de Goias at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Severe Obesity
- What is being tested?
- Nutritional intervention, Nutritional intervention plus olive oil and Olive oil
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 229 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2015to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index ≥ 35 kg/m2
- Residence in Goiânia or metropolitan area
- Patients referred by Secretaria Municipal de Saúde to Severe Obese Nutrition Clinic
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Unidade de Pesquisa Clínica do Hospital das Clínicas/UFG
Goiânia, Goiás, 74605-020
About this study
Official title: Effect of Nutritional Intervention and Olive Oil in Severe Obesity: Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Severe Obesity
- Being tested
- Nutritional intervention, Nutritional intervention plus olive oil, Olive oil
- Keywords
- nutritional management, olive oil, weight loss, body composition, nutrigenomics, polymorphisms, cardiovascular risk, sarcopenia, inflammation, food intake, sedentary lifestyle, patient adherence, bone density
- Medical subject headings
- Obesity, Morbid, Weight Loss, Sarcopenia, Inflammation, Sedentary Behavior, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional interventionBehavioural
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 plus olive oilOther
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.
Olive oilDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Nutritional intervention | Active comparator | Patients under only nutritional intervention for weight loss Receives: Behavioral: Nutritional intervention |
| Nutritional intervention plus olive oil | Experimental | Patients under conventional treatment (nutritional intervention) plus extra virgin olive oil supplementation Receives: Other: Nutritional intervention plus olive oil |
| Olive oil | Experimental | Patient under habitual food consumption plus extra virgin olive oil supplementation Receives: Dietary Supplement: Olive oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anthropometric measurements change
Measurements of weight, arm circumference and Body Mass Index (BMI) will be evaluated to assess anthropometric change.
Measured: 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.
Measured: Baseline, week 12
Secondary outcomes (32)
Change in inflammation parameters
TNF-alfa
Measured: Baseline, week 12
Change in inflammation parameters
Interleucin 6 (IL6), IL1, IL10
Measured: Baseline, week 12
Change in inflammation parameters
Adiponectin
Measured: Baseline, week 12
Change in inflammation parameters
C-reactive protein (CRP)
Measured: Baseline, week 12
Change in inflammation parameters
Neutrophil to lymphocyte ratio (NLR) and lymphocyte to monocyte ratio (LMR)
Measured: Baseline, week 12
Change in metabolic parameters
Lipid profile (total cholesterol, LDL-c, HDL-c, VLDL-c), insulin resistance (HOMA-IR, glycated hemoglobin), fasting glycaemia, hemogram
Measured: Baseline, week 12
Change in kidney function
Creatinine, urea and uric acid
Measured: Baseline, week 12
Change in liver function
AST and ALT
Measured: Baseline, week 12
Change in thyroid function
TSH, T4 and parathyroid hormone
Measured: Baseline, week 12
Change in vitamins
Vitamin D, vitamin B12 and folic acid
Measured: Baseline, week 12
Change in minerals
Iron, calcium, sodium, potassium and zinc
Measured: Baseline, week 12
Change in cardiovascular risk using Global Risk Score (GRS)
Measured: Baseline, week 12
Change in cardiovascular risk using Framingham Risk Score (FRS)
Measured: Baseline, week 12
Change in cardiovascular risk using heart rate variability (HRV)
Measured: Baseline, week 12
Change in cardiovascular risk using Homocystein level
Measured: Baseline, week 12
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
Measured: Baseline, week12
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
Measured: Baseline, week12
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
Measured: Baseline, week12
Change in physical activity practice using Global Physical Activity Questionnaire
Measured: Baseline, week 12
Change in physical activity practice using accelerometry
Measured: Baseline, week 12
Change in food intake using Food Frequency Questionnaire
Measured: Baseline, week 12
Change in food intake using 24 hour recall
Measured: Baseline, week 12
Change in bone health parameters
Change in the following variables: bone density using DXA, falls and fractures and sun exposure
Measured: Baseline, week 12
Change in obesity sarcopenia using muscle mass (evaluated using DXA)
Measured: Baseline, week 12
Change in obesity sarcopenia using handgrip strength
Measured: Baseline, week 12
Change in sarcopenia using usual gait speed
Measured: Baseline, week 12
Adherence to nutritional intervention
It will be evaluated through changes in food consumption (food frequency questionnaire)
Measured: Baseline, week 12
Adherence to the health service
It will be evaluated through attendance to the clinic visits
Measured: Baseline, week 12
Change in symptoms of anxiety and depression using Hospital Anxiety and Depression Scale
Measured: Baseline, week 12
Change in symptoms of binge eating disorderusing Binge Eating Disorder Scale
Measured: Baseline, week 12
Change in musculoskeletal pain using Visual Analog Scale
Measured: Baseline, week 12
Change in musculoskeletal pain using Nordic Musculoskeletal Questionnaire
Measured: Baseline, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Severe ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Goias
- Sponsor type
- University, hospital or other
- Collaborators
- Research Support Foundation of the State of Goiás, Unidade de Pesquisa Clinica (UPC) do Hospital das Clínicas/UFG, Grupo de Estudos em Obesidade Grave (GEOG)
- Responsible party
- Principal investigator, Ana Paula dos Santos Rodrigues, Universidade Federal de Goias
- Investigators
- Erika A Silveira, PhD, Study director, Universidade Federal de Goias - Faculdade de MedicinaAna Paula S Rodrigues, MsC, Principal investigator, Universidade Federal de Goias - Faculdade de MedicinaJacqueline D Souza, MsC, Principal investigator, Universidade Federal de Goias - Faculdade de MedicinaCamila KS Cardoso, MsC, Principal investigator, Universidade Federal de Goias - Faculdade de MedicinaLorena PS Rosa, MsC, Principal investigator, Universidade Federal de Goias - Faculdade de MedicinaAnnelisa SA Santos, MsC, Principal investigator, Universidade Federal de Goias - Faculdade de MedicinaAndrea BS Canheta, MsC, Principal investigator, Universidade Federal de Goias - Faculdade de MedicinaCarolina R Mendonça, MsC, Principal investigator, Universidade Federal de Goias - Faculdade de Medicina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02463435
- Sponsor's protocol ID
- 747.792
- Status last verified
- Nov 2020
- First submitted
- 29 May 2015
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Hill JO, Wyatt HR, Peters JC. Energy balance and obesity. Circulation. 2012 Jul 3;126(1):126-32. doi: 10.1161/CIRCULATIONAHA.111.087213.
PubMed 22753534Horie 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.
PubMed 21233808Sposito 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.
PubMed 17515982Trumbo 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.
PubMed 12449285Rodrigues 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.
PubMed 37789121Silveira 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.
PubMed 35586621Longhi 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.
PubMed 34836393Kellen 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.
PubMed 32992832Canheta 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.
PubMed 32675019Aparecida 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.
PubMed 32455620Cardoso 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.
PubMed 32032997Rodrigues 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.
PubMed 30026785
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nutritional Intervention and Olive Oil in Severe Obesity: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02463435
- Acronym / sponsor ID
- 747.792
- Conditions
- Severe Obesity
- Keywords
- nutritional management, olive oil, weight loss, body composition, nutrigenomics, polymorphisms, cardiovascular risk, sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Universidade Federal de GoiasUniversity, hospital or other
- Collaborators
- Research Support Foundation of the State of Goiás, Unidade de Pesquisa Clinica (UPC) do Hospital das Clínicas/UFG, Grupo de Estudos em Obesidade Grave (GEOG)
- Study start
- Jun 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 4 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nutritional intervention | Active comparator | Behavioral: Nutritional interventionPatients under only nutritional intervention for weight loss |
| Nutritional intervention plus olive oil | Experimental | Other: Nutritional intervention plus olive oilPatients under conventional treatment (nutritional intervention) plus extra virgin olive oil supplementation |
| Olive oil | Experimental | Dietary Supplement: Olive oilPatient under habitual food consumption plus extra virgin olive oil supplementation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body mass index ≥ 35 kg/m2
- Residence in Goiânia or metropolitan area
- Patients referred by Secretaria Municipal de Saúde to Severe Obese Nutrition Clinic
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional interventionConventional 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. | Behavioural | Nutritional intervention |
| Nutritional intervention plus olive oilNutritional 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. | Other | Nutritional intervention plus olive oil |
| Olive oilPatients 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. | Dietary supplement | Olive oil |
Primary outcome
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.
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.
32 secondary outcomes
Change in inflammation parameters
Time frame: Baseline, week 12
Change in inflammation parameters
Time frame: Baseline, week 12
Change in inflammation parameters
Time frame: Baseline, week 12
Change in inflammation parameters
Time frame: Baseline, week 12
Change in inflammation parameters
Time frame: Baseline, week 12
Change in metabolic parameters
Time frame: Baseline, week 12
Change in kidney function
Time frame: Baseline, week 12
Change in liver function
Time frame: Baseline, week 12
Change in thyroid function
Time frame: Baseline, week 12
Change in vitamins
Time frame: Baseline, week 12
Change in minerals
Time frame: Baseline, week 12
Change in cardiovascular risk using Global Risk Score (GRS)
Time frame: Baseline, week 12
Change in cardiovascular risk using Framingham Risk Score (FRS)
Time frame: Baseline, week 12
Change in cardiovascular risk using heart rate variability (HRV)
Time frame: Baseline, week 12
Change in cardiovascular risk using Homocystein level
Time frame: Baseline, week 12
Polymorphism Pro12Ala of Peroxisome Proliferator-Activated Receptor Alfa (PPAR-alfa)
Time frame: Baseline, week12
PolymorphismTrp64Arg of Beta-3 Adrenergic Receptor (ADRB3) gene
Time frame: Baseline, week12
Polymorphism -174G>C of Interleukin 6 (IL6) gene.
Time frame: Baseline, week12
Change in physical activity practice using Global Physical Activity Questionnaire
Time frame: Baseline, week 12
Change in physical activity practice using accelerometry
Time frame: Baseline, week 12
Change in food intake using Food Frequency Questionnaire
Time frame: Baseline, week 12
Change in food intake using 24 hour recall
Time frame: Baseline, week 12
Change in bone health parameters
Time frame: Baseline, week 12
Change in obesity sarcopenia using muscle mass (evaluated using DXA)
Time frame: Baseline, week 12
Change in obesity sarcopenia using handgrip strength
Time frame: Baseline, week 12
Change in sarcopenia using usual gait speed
Time frame: Baseline, week 12
Adherence to nutritional intervention
Time frame: Baseline, week 12
Adherence to the health service
Time frame: Baseline, week 12
Change in symptoms of anxiety and depression using Hospital Anxiety and Depression Scale
Time frame: Baseline, week 12
Change in symptoms of binge eating disorderusing Binge Eating Disorder Scale
Time frame: Baseline, week 12
Change in musculoskeletal pain using Visual Analog Scale
Time frame: Baseline, week 12
Change in musculoskeletal pain using Nordic Musculoskeletal Questionnaire
Time frame: Baseline, week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Background: PubMed 22753534Hill JO, Wyatt HR, Peters JC. Energy balance and obesity. Circulation. 2012 Jul 3;126(1):126-32. doi: 10.1161/CIRCULATIONAHA.111.087213.
- Background: PubMed 21233808Horie 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.
- Background: PubMed 17515982Sposito 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.
- Background: PubMed 12449285Trumbo 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.
- Derived from this study: PubMed 37789121Rodrigues 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.
- Derived from this study: PubMed 35586621Silveira 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.
- Derived from this study: PubMed 34836393Longhi 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.
- Derived from this study: PubMed 32992832Kellen 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.
- Derived from this study: PubMed 32675019Canheta 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.
- Derived from this study: PubMed 32455620Aparecida 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.
- Derived from this study: PubMed 32032997Cardoso 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.
- Derived from this study: PubMed 30026785Rodrigues 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erika A Silveira, PhD study director
Universidade Federal de Goias - Faculdade de Medicina
Ana Paula S Rodrigues, MsC principal investigator
Universidade Federal de Goias - Faculdade de Medicina
Jacqueline D Souza, MsC principal investigator
Universidade Federal de Goias - Faculdade de Medicina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional intervention, Nutritional intervention plus olive oil and Olive oil in people with Severe Obesity, run by Universidade Federal de Goias at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anthropometric measurements change (time frame: Baseline, week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02463435, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.