Ingestion of Lipids and Changes in Cerebral Blood Flow of People With Obesity
NCT ID: NCT02079116
Last Updated: 2014-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2012-01-31
2014-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
Study Groups
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60 grams of fat plus water solution
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.
60 grams of fat plus water solution
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:
* 300 mL final volume of the solution.
* Time of oral ingestion inferior than 2 minutes.
* 60 minutes before the radiopharmaceutical injection.
* 12 hours fasting minimum.
Pure water
Pure water at ambient temperature is administered to each volunteer, being of the with obesity group or the without obesity group, as follow:
* 300 mL final volume of the solution.
* Time of oral ingestion inferior than 2 minutes.
* 30 minutes before the radiopharmaceutical injection.
* 12 hours fasting minimum.
Pure water.
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).
60 grams of fat plus water solution
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:
* 300 mL final volume of the solution.
* Time of oral ingestion inferior than 2 minutes.
* 60 minutes before the radiopharmaceutical injection.
* 12 hours fasting minimum.
Pure water
Pure water at ambient temperature is administered to each volunteer, being of the with obesity group or the without obesity group, as follow:
* 300 mL final volume of the solution.
* Time of oral ingestion inferior than 2 minutes.
* 30 minutes before the radiopharmaceutical injection.
* 12 hours fasting minimum.
Interventions
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60 grams of fat plus water solution
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:
* 300 mL final volume of the solution.
* Time of oral ingestion inferior than 2 minutes.
* 60 minutes before the radiopharmaceutical injection.
* 12 hours fasting minimum.
Pure water
Pure water at ambient temperature is administered to each volunteer, being of the with obesity group or the without obesity group, as follow:
* 300 mL final volume of the solution.
* Time of oral ingestion inferior than 2 minutes.
* 30 minutes before the radiopharmaceutical injection.
* 12 hours fasting minimum.
Eligibility Criteria
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Inclusion Criteria
* Regular menses.
* Weight inferior than 120 Kg and body mass index (BMI) between 30 and 40 kg/m2, for the group with obesity.
* BMI between 18,5 and 24,9 kg/m2, for the group without obesity.
Exclusion Criteria
* Psychiatric disorders, alcoholism, smoking or illicit drug abuse.
* Pregnancy or desire to be pregnant
* Use of medications, excluding contraceptives.
* Contraindication for magnetic resonance imaging.
* Be in treatment for obesity.
18 Years
40 Years
FEMALE
Yes
Sponsors
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Fundação de Amparo à Pesquisa do Estado de São Paulo
OTHER_GOV
University of Sao Paulo
OTHER
Responsible Party
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Julio Sergio Marchini
Full Professor of Internal Medicine Department at Ribeirão Preto Medical School
Principal Investigators
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Júlio S Marchini, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Ribeirão Preto Medical School. São Paulo University (USP)
Locations
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Clinical Hospital of Ribeirao Preto
Ribeirão Preto, São Paulo, Brazil
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Record in the National Committee of Ethics in Research
Other Identifiers
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CAAE - 0335.0.004.000-11
Identifier Type: REGISTRY
Identifier Source: secondary_id
Process HCRP: 14080/2011
Identifier Type: -
Identifier Source: org_study_id
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