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

U

University of Sao Paulo

Status

Completed

Conditions

Obesity

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT02079116
Process HCRP: 14080/2011
CAAE - 0335.0.004.000-11 (Registry Identifier)

Details and patient eligibility

About

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

Enrollment

20 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

20 participants in 2 patient groups, including a placebo group

60 grams of fat plus water solution
Experimental group
Description:
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.
Treatment:
Other: Pure water
Other: 60 grams of fat plus water solution
Pure water.
Placebo Comparator group
Description:
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).
Treatment:
Other: Pure water
Other: 60 grams of fat plus water solution

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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