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

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ClinicalTrials.gov Identifier: NCT03077074
Recruitment Status : Unknown
Verified February 2017 by Ram Weiss, Hadassah Medical Organization.
Recruitment status was:  Recruiting
First Posted : March 10, 2017
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Ram Weiss, Hadassah Medical Organization

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.

Condition or disease Intervention/treatment Phase
Changes in Functional MRI Other: low carbohydrate consumption Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Brain Responses to Visual Food Cues in Response to a Low Carbohydrate Diet
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : September 1, 2019

Arm Intervention/treatment
Experimental: Low carbohydrate consumption
consumption of up to 60 grams of carbohydrate a day for 10 days FMRI will be performed prior and after the intervention during the luteal cycle phase
Other: low carbohydrate consumption
consumption of up to 60 grams of carbohydrate a day for 10 days FMRI will be performed prior and after the intervention during the luteal cycle phase




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only females without contraceptive treatment and with regular menstrual cycle
Accepts Healthy Volunteers:   Yes
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

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): NCT03077074


Contacts
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Contact: Ram Weiss, professor 972508946469 ramw@ekmd.huji.ac.il

Locations
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Israel
Hadassah hebrew university Recruiting
Jerusalem Region, Israel
Contact: Ram Weiss, professor    972508946469    ramw@ekmd.huji.ac.il   
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
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Principal Investigator: Ram Weiss, Professor Hadassah medical center

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Responsible Party: Ram Weiss, Ram Weiss, clinical professor and principle investigator, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT03077074     History of Changes
Other Study ID Numbers: 12-0580-HMO
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No