NCT02162524

Brief Summary

The primary purpose of this study is to quantify activation of regions of the brain associated with appetite and reward after viewing high sugar and high fat (HS/HF) images compared to control images following long-term aerobic exercise.

  1. 1.After long-term aerobic exercise compared to a no-exercise control group, viewing HS/HF food images vs. control images will result in higher activation of regions of the brain associate with appetite (hypothalamus).
  2. 2.After long-term aerobic exercise compared to a no-exercise control group 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 lower 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 overweight and obese men and women.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 12, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

January 11, 2016

Status Verified

January 1, 2016

Enrollment Period

1.5 years

First QC Date

September 17, 2013

Last Update Submit

January 7, 2016

Conditions

Keywords

aerobic exerciseobesityenergy balance

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.

    baseline and post (6 month intervention)

Study Arms (2)

No Exercise Control

NO INTERVENTION

Healthy Living Group

Aerobic Exercise Group

ACTIVE COMPARATOR

Persons are aerobically exercising.

Behavioral: Aerobic Exercise

Interventions

The exercise groups will be closely monitored during exercise sessions for six months in our exercise-training laboratory. The intensity will be 65% VO2peak and all exercise will occur on a treadmill. One exercise group will obtain 8 KKW (kcal/kg/week) over 3-4 sessions per week, which will result in each session lasting approximately 30 minutes. The other exercise group will obtain 20 KKW, performing 4-5 sessions per week for approximately 50-70 minutes per session. These groups are combined for this ancillary study.

Also known as: 8KKW, 20KKW
Aerobic Exercise Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or Female
  • years old (inclusive)
  • Weigh less than 350 lbs
  • Body mass index (BMI) between 25-43 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • John W Apolzan, PhD

    PBRC

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral Fellow

Study Record Dates

First Submitted

September 17, 2013

First Posted

June 12, 2014

Study Start

January 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

January 11, 2016

Record last verified: 2016-01

Locations