Ingestion of Lipids and Changes in Cerebral Blood Flow of People With Obesity

Obesity Clinical Trial

Official title:

Acute Ingestion of Lipids and Alteration of Cerebral Perfusion in Obese Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02079116
• Other study ID #: Process HCRP: 14080/2011
• Secondary ID: CAAE - 0335.0.00
• Status: Completed
• Phase: N/A
• First received: March 1, 2014
• Last updated: May 13, 2014
• Start date: January 2012
• Est. completion date: April 2014

Study information

• Verified date: May 2014
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

This study aims to determine changes in cerebral blood flow of people with obesity after the ingestion of fat.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Live in Ribeirão Preto, São Paulo - Brazil.

• 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:

• High blood pressure, diabetes, glucose intolerance or impaired fasting glycemia, metabolic syndrome, hypothyroidism and any kidney, liver, heart or neurologic disease.

• 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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Brazil	Clinical Hospital of Ribeirao Preto	Ribeirão Preto	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (10)

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. — View Citation

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. Review. — View Citation

Goldstone AP. The hypothalamus, hormones, and hunger: alterations in human obesity and illness. Prog Brain Res. 2006;153:57-73. Review. — View Citation

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. Review. — View Citation

Kyle UG, Bosaeus I, De Lorenzo AD, Deurenberg P, Elia M, Gómez 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. Review. — View Citation

Lairon D, Lopez-Miranda J, Williams C. Methodology for studying postprandial lipid metabolism. Eur J Clin Nutr. 2007 Oct;61(10):1145-61. Epub 2007 Apr 25. Review. Erratum in: Eur J Clin Nutr. 2008 Sep;62(9):1154. — View Citation

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. Review. — View Citation

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. — View Citation

Tataranni PA, DelParigi A. Functional neuroimaging: a new generation of human brain studies in obesity research. Obes Rev. 2003 Nov;4(4):229-38. Review. — View Citation

Wichert-Ana L, Velasco TR, Terra-Bustamante VC, Araújo D Jr, Júnior 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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).	60 and 30 minutes before, at the time and 30 and 60 minutes after the radiopharmaceutical injection.	No
Secondary	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.	No

External Links

•   Record in the National Committee of Ethics in Research
•   Website of the Clinical Hospital of the Ribeirão Preto Medical School.