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Clinical Trials/NCT03077074
NCT03077074UnknownNot Applicable

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

Hadassah Medical Organization1 site in 1 country40 target enrollmentStarted: January 1, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
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

Study 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.

Study Design

Study Type
Interventional
Intervention Model
Sequential
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ram Weiss

Ram Weiss, clinical professor and principle investigator

Hadassah Medical Organization

Study Sites (1)

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