Effects of Images Following Beverage Ingestion on Brain Activation

NCT02163304 | Withdrawn

• 1 other identifier: PBRC 2013-031
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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. 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. 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. 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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• fMRI

  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.

  Visit 1,2,3

Secondary Outcomes (1)

• VAS

  Visit 1, 2, 3

Study Arms (3)

Artificial Sweetner

ACTIVE COMPARATOR

Artificial Sweetener

Other: Artificial Sweetner

Tasteless Solution

PLACEBO COMPARATOR

12 oz tasteless solution

Other: Tasteless Solution

Sucrose

ACTIVE COMPARATOR

12 oz 75 g sucrose beverage

Other: Sucrose

Interventions

Sucrose OTHER

Sucrose

Artificial Sweetner OTHER

Artificial Sweetner

Tasteless Solution OTHER

Tasteless Solution

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Sucrose

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• John W Apolzan, PhD

  PBRC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Fellow

Study Record Dates

• First Submitted: September 17, 2013
• First Posted: June 13, 2014
• Study Start: August 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 11, 2016

Record last verified: 2016-01

Locations

US (1)