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Effects of Images Following Beverage Ingestion on Brain Activation (Sweety)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02163304
Recruitment Status : Withdrawn
First Posted : June 13, 2014
Last Update Posted : January 11, 2016
Sponsor:
Information provided by (Responsible Party):
John Apolzan, Pennington Biomedical Research Center

Brief Summary:

The primary purpose of this study is to quantify activation of regions of the brain associated with taste, appetite, and reward after viewing high sugar and high fat (HS/HF) images compared to control images following ingestion of (1) an artificially sweetened solution, (2) a sucrose solution, and (3) a tasteless control solution in normal weight vs. obese women. This is a repeated measures study design; hence, data are collected on three days corresponding to the three solutions. Body mass index (BMI) is a between subjects measure.

  1. After consuming an artificially sweetened solution and a sucrose solution compared to a tasteless solution, viewing HS/HF food images vs. control images will result in higher activation of taste pathways (frontal operulum and anterior insula (FO/AI)) in the brain.
  2. After consumption of a sucrose solution compared to an artificially sweetened solution and a tasteless solution, viewing HS/HF food images vs. control images will result in higher activation of regions of the brain associate with appetite (hypothalamus).
  3. After consumption of a sucrose solution compared to an artificially sweetened solution and a tasteless solution, viewing HS/HF food images vs. control images will result in higher activation of regions of the brain associated with reward [amygdala, anterior cingulate cortex (ACC), Orbitalfrontal Cortex (OFC), and ventral tegmental area (VTA), striatum, insula] in obese but not normal weight women. After consuming an artificially sweetened solution compared to a tasteless solution, viewing HS/HF images vs. control images will result in no differences in activation of reward pathways of the brain.

Condition or disease Intervention/treatment Phase
Obesity Other: Sucrose Other: Artificial Sweetner Other: Tasteless Solution Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Images Following Beverage Ingestion on Brain Activation
Study Start Date : August 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Arm Intervention/treatment
Active Comparator: Artificial Sweetner
Artificial Sweetener
Other: Artificial Sweetner
Placebo Comparator: Tasteless Solution
12 oz tasteless solution
Other: Tasteless Solution
Active Comparator: Sucrose
12 oz 75 g sucrose beverage
Other: Sucrose



Primary Outcome Measures :
  1. fMRI [ Time Frame: Visit 1,2,3 ]
    fMRI will be performed using a General Electric Signa Excite HDxT 3.0T scanner (Milwaukee, WI) approximately 10 minutes post beverage ingestion. The field of view is 24-28 cm. The scanner is equipped with functional components from GE. Supplemental components include a projection system and eye imaging system from Avotec , Inc. An eight channel head coil will be utilized for all fMRI scans, and E-prime® software will be utilized for computerized experiment design, data collection, and analysis. Visual food and control cues will be presented in a mixed event block design with blocks of HS/HF and control images. Food cues consist of full-color pictures displaying foods within a category (HS/HF). One food item will be shown in each picture. Control cues consist of scrambled images that match the food cues in color intensity and frequency. Each block is 30s in length and 6 images are presented anywhere from 3-7seconds. Total task time will be ~30 minutes.


Secondary Outcome Measures :
  1. VAS [ Time Frame: Visit 1, 2, 3 ]
    Visual Analog Scales (VAS). Paper VAS will be used to measure subjective ratings of hunger, satiety, fullness, prospective food consumption, and thirst during the present study. When completing the VAS, participants rate the intensity of subjective states or opinions on a line anchored from "not at all" to "extremely." The line is divided into 100 equal units. These VAS will be anchored from "strongly disagree" to "strongly agree." The VAS that measure appetite ratings will be completed at pre and post beverage preload and minute 60 (or immediately post scan) and 120 following the fMRI scan(s).



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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female
  • 20-35 years old (inclusive)
  • Weigh less than 350 lbs
  • Weight stable (>±5 kg in the last 6 months).
  • Body mass index (BMI) between 20-25 kg/m2 or 30-35 kg/m2.
  • Willing to fast for 10 hours prior to examination.
  • Right handed.

Exclusion Criteria:

  • Diagnosis (by self report) of diabetes
  • Diagnosis (by self report) of neurological condition
  • Current or past alcohol or drug abuse problem.
  • Smoking
  • Have internal metal medical devices including cardiac pacemakers, aortic or cerebral aneurysm clips, artificial heart valves, ferromagnetic implants, shrapnel, wire sutures, joint replacements, bone or joint pins/rods/screws/clips, metal plates, metal fragments in your eye, or non-removable metal jewelry such as rings.
  • Unable or unwilling to complete the imaging procedures for the duration of the MRI scan due to claustrophobia or other reason.

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): NCT02163304


Locations
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United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
Investigators
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Principal Investigator: John W Apolzan, PhD PBRC
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Responsible Party: John Apolzan, Postdoctoral Fellow, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT02163304    
Other Study ID Numbers: PBRC 2013-031
First Posted: June 13, 2014    Key Record Dates
Last Update Posted: January 11, 2016
Last Verified: January 2016