Ignite Creation Date:
2024-05-06 @ 7:05 AM
Last Modification Date:
2024-10-26 @ 11:44 AM
Study NCT ID:
NCT02463435
Status:
COMPLETED
Last Update Posted:
2020-11-13
First Post:
2015-05-29
Brief Title:
Effect of Nutritional Intervention and Olive Oil in Severe Obesity
Sponsor:
Universidade Federal de Goias
Organization:
Universidade Federal de Goias
Study Overview
Official Title:
Effect of Nutritional Intervention and Olive Oil in Severe Obesity Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Obesity is a worldwide epidemic with increasing prevalence specially severe obesity Body Mass Index BMI 35 kgm2 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 -174GC of IL6 gene e Trp64Arg of ADRB3 gene on nutritional intervention effectiveness with and without olive oil This research looks for improving severely obese patients 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 3999 kgm2 and BMI 40 kgm2 allocation ratio 111 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 05 to 10 weekly weight reduction according to the patients 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 429
This research will be conducted at a capital of center Brazil at Unidade de Pesquisa Clínica of Hospital das ClínicaUFG Faculty of MedicineUFG
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 05 to 10 weekly weight reduction according to the patients 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 429
This research will be conducted at a capital of center Brazil at Unidade de Pesquisa Clínica of Hospital das ClínicaUFG Faculty of MedicineUFG
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None