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Clinical Trials/NCT03077074
NCT03077074
Unknown
Not Applicable

Brain Responses to Visual Food Cues in Response to a Low Carbohydrate Diet

Hadassah Medical Organization1 site in 1 country40 target enrollmentJanuary 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Changes in Functional MRI
Sponsor
Hadassah Medical Organization
Enrollment
40
Locations
1
Primary Endpoint
fMRI:(Functional MRI) changes in activation patterns of reward associated regions will be assessed prior and after dietary intervention
Last Updated
9 years ago

Overview

Brief Summary

The aim is to profile and elucidate the hormonal and neurological system interaction to food related behavior. The stimulus used will include visual and taste (gustatory) stimuli. The study will profile induced correlations of metabolic parameters, gut hormones and brain region (ROI - regions of interest) activation and interaction. In this study we will use fMRI (functional MRI) to compare brain responses in obese, normal-weight and reduced weight subjects. The food stimuli will be blocked into specific categories to allow for investigation of different responses to alternating energy density foods. The response will be tested prior to and following a brief low carbohydrate dietary regimen.

Detailed Description

The study will be a longitudinal study where the participants will come back twice on the same phase of the period- both visits in the luteal phase with a month between each visit. In this part of the study there will be 40 participants with a wider range of BMI. This phase of the study will include a nutritional intervention - the participants will be asked to have a carbohydrate restricted diet (60 grams of carbohydrate)- for a period of a month with no caloric restriction. Food records will be kept and followed and a ketone test (blood test) will be done on the morning of the study visits.

Registry
clinicaltrials.gov
Start Date
January 1, 2017
End Date
September 1, 2019
Last Updated
9 years ago
Study Type
Interventional
Study Design
Sequential
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ram Weiss

Ram Weiss, clinical professor and principle investigator

Hadassah Medical Organization

Eligibility Criteria

Inclusion Criteria

  • Age 18- 45 years
  • No contraindication to enter the MRI
  • No significant visual problems that may hamper visualization of visual stimuli within the magnet
  • No contraceptive hormonal replacement
  • relatively regular menstrual cycle

Exclusion Criteria

  • contraceptive hormonal replacement
  • under the age of 18
  • over the age of 45
  • pharmacological treatment that can effect brain response
  • Irregular menstrual cycle

Outcomes

Primary Outcomes

fMRI:(Functional MRI) changes in activation patterns of reward associated regions will be assessed prior and after dietary intervention

Time Frame: fMRI will be preformed in the luteal menstrual phase at two time points (at least a month apart). a comparison will be made between pre and post intervention.

BOLD (Blood Oxygen Level Dependent) responses will we quantified in regions of interest

Study Sites (1)

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