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| ID | Type | Description | Link |
|---|---|---|---|
| CAAE - 0335.0.004.000-11 | Registry Identifier | Sistema Nacional de Informações sobre Ética em Pesquisa |
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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
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This study aims to determine changes in cerebral blood flow of people with obesity after the ingestion of fat.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 60 grams of fat plus water solution | Experimental | In the group with 10 volunteers with obesity, some of them are submitted first to the 60 grams of fat plus water solution (meal challenge) and in another time to only water. Also, in the group with 10 volunteers without obesity, some of them are submitted first to the 60 grams of fat plus water solution (meal challenge) and in another time to only water. |
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| Pure water. | Placebo Comparator | In the same group with 10 volunteers with obesity, some of them are submitted first to only water (control) and in another time to the 60 grams of fat plus water solution (meal challenge). Also, in the same group with 10 volunteers without obesity, some of them are submitted first to only water (control) and in another time to the 60 grams of fat plus water solution (meal challenge). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 60 grams of fat plus water solution | Other | A solution composed by 60 grams of fat and water at ambient temperature is administered to each volunteer, being of the with obesity group or the without obesity group, as follow:
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| Measure | Description | Time Frame |
|---|---|---|
| Regional cerebral blood flow (rCBF) changes after a meal challenge, measured by Single Single-photon emission computed tomography (SPECT) and statistical parametric mapping. | Using 99m technetium ecd radiopharmaceutical, this study aims to detect rCBF differences between SPECT images performed after a meal challenge composed by 60 grams of fat and water and also after a challenge constituted by only water (control), both ingested orally. This approach is performed in a group of 10 people with obesity and also in 10 people without obesity. | 60 minutes after a meal challenge (time of radiopharmaceutical injection) |
| Measure | Description | Time Frame |
|---|---|---|
| Blood levels mean differences within both groups, with and without obesity and across these groups, of hormones and metabolites by multiplexed assay using luminex technology and spectrophotometry, respectively. | This study looks for mean differences of blood levels within and across groups with and without obesity. The metabolites and hormones/cytokines measured are, respectively: glucose and triacylglycerols (measured by spectrophotometry), insulin, leptin, amylin, interleukin 6 (IL-6), tumor necrosis factor alpha, active ghrelin, peptide yy (PYY) and pancreatic polypeptide (PP) (multiplexed assay using luminex). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Júlio S Marchini, Ph.D | Ribeirão Preto Medical School. São Paulo University (USP) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Hospital of Ribeirao Preto | Ribeirão Preto | São Paulo | 14048-900 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14649373 | Background | Tataranni PA, DelParigi A. Functional neuroimaging: a new generation of human brain studies in obesity research. Obes Rev. 2003 Nov;4(4):229-38. doi: 10.1046/j.1467-789x.2003.00111.x. | |
| 15380917 | Background | Kyle UG, Bosaeus I, De Lorenzo AD, Deurenberg P, Elia M, Gomez JM, Heitmann BL, Kent-Smith L, Melchior JC, Pirlich M, Scharfetter H, Schols AM, Pichard C; Composition of the ESPEN Working Group. Bioelectrical impedance analysis--part I: review of principles and methods. Clin Nutr. 2004 Oct;23(5):1226-43. doi: 10.1016/j.clnu.2004.06.004. |
| Label | URL |
|---|---|
| Record in the National Committee of Ethics in Research | View source |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Pure water | Other | Pure water at ambient temperature is administered to each volunteer, being of the with obesity group or the without obesity group, as follow:
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| 60 and 30 minutes before, at the time and 30 and 60 minutes after the radiopharmaceutical injection. |
| Resting energy expenditure (REE) and body composition measurements by indirect calorimetry and electrical bioimpedance, respectively. | This study also aims to measure and compare the REE by indirect calorimetry with a Quark (Cosmed, Italy) calorimeter and the body composition by Byodinamics 450 (Biodynamics Corp., United States) within the two groups and across them. | 6 hours before SPECT acquisition. |
| 22281699 | Background | Lambert JE, Parks EJ. Postprandial metabolism of meal triglyceride in humans. Biochim Biophys Acta. 2012 May;1821(5):721-6. doi: 10.1016/j.bbalip.2012.01.006. Epub 2012 Jan 17. |
| 17457341 | Background | Lairon D, Lopez-Miranda J, Williams C. Methodology for studying postprandial lipid metabolism. Eur J Clin Nutr. 2007 Oct;61(10):1145-61. doi: 10.1038/sj.ejcn.1602749. Epub 2007 Apr 25. |
| 16876568 | Background | Goldstone AP. The hypothalamus, hormones, and hunger: alterations in human obesity and illness. Prog Brain Res. 2006;153:57-73. doi: 10.1016/S0079-6123(06)53003-1. |
| 18945945 | Background | Figlewicz DP, Benoit SC. Insulin, leptin, and food reward: update 2008. Am J Physiol Regul Integr Comp Physiol. 2009 Jan;296(1):R9-R19. doi: 10.1152/ajpregu.90725.2008. Epub 2008 Oct 22. |
| 15630408 | Background | Kishi T, Elmquist JK. Body weight is regulated by the brain: a link between feeding and emotion. Mol Psychiatry. 2005 Feb;10(2):132-46. doi: 10.1038/sj.mp.4001638. |
| 15627585 | Background | DelParigi A, Chen K, Salbe AD, Reiman EM, Tataranni PA. Sensory experience of food and obesity: a positron emission tomography study of the brain regions affected by tasting a liquid meal after a prolonged fast. Neuroimage. 2005 Jan 15;24(2):436-43. doi: 10.1016/j.neuroimage.2004.08.035. |
| 12921877 | Background | Suen VM, Silva GA, Tannus AF, Unamuno MR, Marchini JS. Effect of hypocaloric meals with different macronutrient compositions on energy metabolism and lung function in obese women. Nutrition. 2003 Sep;19(9):703-7. doi: 10.1016/s0899-9007(03)00104-7. |
| 11380575 | Background | Wichert-Ana L, Velasco TR, Terra-Bustamante VC, Araujo D Jr, Junior VA, Kato M, Leite JP, Assirati JA, MacHado HR, Bastos AC, Sakamoto AC. Typical and atypical perfusion patterns in periictal SPECT of patients with unilateral temporal lobe epilepsy. Epilepsia. 2001 May;42(5):660-6. doi: 10.1046/j.1528-1157.2001.41900.x. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |