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

NCT02079116 | Completed

• 2 other identifiers: Process HCRP: 14080/2011CAAE - 0335.0.004.000-11
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity

Keywords

Obesity; Lipids; Single Photon Emission Computed Tomography; Functional Neuroimaging

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (2)

• 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.

  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.

  6 hours before SPECT acquisition.

Study Arms (2)

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.

Other: 60 grams of fat plus water solution; Other: Pure water

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).

Other: 60 grams of fat plus water solution; Other: Pure water

Interventions

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: * 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.

60 grams of fat plus water solution; Pure water.

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: * 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.

60 grams of fat plus water solution; Pure water.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Clinical Hospital of Ribeirao Preto

Ribeirão Preto, São Paulo, 14048-900, Brazil

Location

Related Publications (10)

• 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.

  PMID: 14649373 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.

  PMID: 15380917 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.

  PMID: 22281699 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.

  PMID: 17457341 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.

  PMID: 16876568 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.

  PMID: 18945945 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.

  PMID: 15630408 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.

  PMID: 15627585 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.

  PMID: 12921877 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.

  PMID: 11380575 BACKGROUND

Related Links

• Record in the National Committee of Ethics in Research

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Júlio S Marchini, Ph.D

  Ribeirão Preto Medical School. São Paulo University (USP)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Internal Medicine Department at Ribeirão Preto Medical School

Study Record Dates

• First Submitted: March 1, 2014
• First Posted: March 5, 2014
• Study Start: January 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 14, 2014

Record last verified: 2014-05

Locations

BR (1)