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

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Other: 60 grams of fat plus water solution; Other: Pure water

• Registration Number: NCT02079116
• Lead Sponsor: University of Sao Paulo

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2014-03-01
• Study First Submitted QC: 2014-03-01
• Study First Posted: 2014-03-05
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-13
• Last Update Posted: 2014-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
60 grams of fat plus water solution	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	Pure water	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.
Pure water.	60 grams of fat plus water solution	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).
Pure water.	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).

Primary Outcome Measures

Name	Time	Method
Regional cerebral blood flow (rCBF) changes after a meal challenge, measured by Single Single-photon emission computed tomography (SPECT) and statistical parametric mapping.	60 minutes after a meal challenge (time of radiopharmaceutical injection)	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.

Secondary Outcome Measures

Name	Time	Method
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.	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).
Resting energy expenditure (REE) and body composition measurements by indirect calorimetry and electrical bioimpedance, respectively.	6 hours before SPECT acquisition.	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.

Trial Locations

Locations (1)

Clinical Hospital of Ribeirao Preto; 🇧🇷 Ribeirão Preto, Sao Paulo, Brazil