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

Changes in Functional MRI Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03077074
• Other study ID #: 12-0580-HMO
• Status: Recruiting
• Phase: N/A
• First received: February 20, 2017
• Last updated: March 20, 2017
• Start date: January 1, 2017
• Est. completion date: September 1, 2019

Study information

• Verified date: February 2017
• Source: Hadassah Medical Organization
• Contact: Ram Weiss, professor
• Phone: 972508946469
• Email: ramw[@]ekmd.huji.ac.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 1, 2019
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Changes in Functional MRI

Intervention

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

Locations

Country	Name	City	State
Israel	Hadassah hebrew university	Jerusalem Region

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.