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

NCT ID: NCT03077074

Last Updated: 2017-03-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2019-09-01

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.

Conditions

Changes in Functional MRI

Study Design

• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

low carbohydrate consumption

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Ram Weiss

Ram Weiss, clinical professor and principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ram Weiss, Professor

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

Hadassah hebrew university

Jerusalem Region, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Ram Weiss, professor

Role: CONTACT

ramw@ekmd.huji.ac.il

972508946469

Facility Contacts

Ram Weiss, professor

Role: primary

ramw@ekmd.huji.ac.il

972508946469

Other Identifiers

12-0580-HMO

Identifier Type: -

Identifier Source: org_study_id