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

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.

Study Overview

• Status: Unknown
• Conditions: Changes in Functional MRI
• Intervention / Treatment: Other: low carbohydrate consumption

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Jerusalem Region, Israel
    • Recruiting
    • Hadassah Hebrew University
    • Contact: Ram Weiss, professor; Phone Number: 972508946469; Email: ramw@ekmd.huji.ac.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fMRI:(Functional MRI) changes in activation patterns of reward associated regions will be assessed prior and after dietary intervention	BOLD (Blood Oxygen Level Dependent) responses will we quantified in regions of interest	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.

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization
• Investigators: Principal Investigator: Ram Weiss, Professor, Hadassah Medical Organization

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: February 20, 2017
• First Submitted That Met QC Criteria: March 6, 2017
• First Posted (Actual): March 10, 2017

Study Record Updates

• Last Update Posted (Actual): March 21, 2017
• Last Update Submitted That Met QC Criteria: March 20, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 12-0580-HMO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No