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

N/ACompletedNCT02079116

University of Sao Paulo20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Obesity

Interventions

60 grams of fat plus water solutionOTHER

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 waterOTHER

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

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Clinical Hospital of Ribeirao Preto

Ribeirão Preto, São Paulo, Brazil

Outcomes

Primary Outcomes

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.

Time frame: 60 minutes after a meal challenge (time of radiopharmaceutical injection)

Secondary Outcomes

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).

Time frame: 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.

Time frame: 6 hours before SPECT acquisition.

Data from ClinicalTrials.gov

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