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

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ClinicalTrials.gov Identifier: NCT02079116
Recruitment Status : Completed
First Posted : March 5, 2014
Last Update Posted : May 14, 2014
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Julio Sergio Marchini, 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.

Condition or disease Intervention/treatment Phase
Obesity Other: 60 grams of fat plus water solution Other: Pure water Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Acute Ingestion of Lipids and Alteration of Cerebral Perfusion in Obese Patients.
Study Start Date : January 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

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: 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.

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.

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: 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.

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02079116


Locations
Brazil
Clinical Hospital of Ribeirao Preto
Ribeirão Preto, Sao Paulo, Brazil, 14048-900
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Júlio S Marchini, Ph.D Ribeirão Preto Medical School. São Paulo University (USP)

Additional Information:
Publications:

Responsible Party: Julio Sergio Marchini, Full Professor of Internal Medicine Department at Ribeirão Preto Medical School, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02079116     History of Changes
Other Study ID Numbers: Process HCRP: 14080/2011
CAAE - 0335.0.004.000-11 ( Registry Identifier: Sistema Nacional de Informações sobre Ética em Pesquisa )
First Posted: March 5, 2014    Key Record Dates
Last Update Posted: May 14, 2014
Last Verified: May 2014

Keywords provided by Julio Sergio Marchini, University of Sao Paulo:
Obesity
Lipids
Single Photon Emission Computed Tomography
Functional Neuroimaging

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Pharmaceutical Solutions
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action