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

May 13, 2014 updated by: Julio Sergio Marchini, University of Sao Paulo

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Sao Paulo
      • Ribeirão Preto, Sao Paulo, Brazil, 14048-900
        • Clinical Hospital of Ribeirao Preto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
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.
Placebo Comparator: 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).
Other: 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.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resting energy expenditure (REE) and body composition measurements by indirect calorimetry and electrical bioimpedance, respectively.
Time Frame: 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.
6 hours before SPECT acquisition.
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.
Time Frame: 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).
60 and 30 minutes before, at the time and 30 and 60 minutes after the radiopharmaceutical injection.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

March 1, 2014

First Submitted That Met QC Criteria

March 1, 2014

First Posted (Estimate)

March 5, 2014

Study Record Updates

Last Update Posted (Estimate)

May 14, 2014

Last Update Submitted That Met QC Criteria

May 13, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Process HCRP: 14080/2011
  • CAAE - 0335.0.004.000-11 (Registry Identifier: Sistema Nacional de Informações sobre Ética em Pesquisa)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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