- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03985787
Resistance Training and Appetite Regulation
The Effects of Resistance Training on Appetite Regulation
Study Overview
Detailed Description
Aim 1: To determine if RT impacts neuronal function associated with food intake behavior in a manner favoring reduced EI in overweight/obese adults.
Hypothesis: Compared to pre, post-RT fMRI measures will demonstrate ↓ neuronal responses to food cues in the insula, prefrontal cortex, and hypothalamus, brain regions implicated in reward, impulsivity, motivation, and regulation of ingestive behaviors. These changes will be associated with ad libitum EI.
Aim 2: To determine if RT impacts appetite-related peptides, ratings, and food intake behaviors in a manner favoring reduced EI in overweight/obese adults.
Hypothesis: Compared to pre, post-RT measures will show changes in appetite-related peptides, ratings (↓ hunger ↑ satiety), and behaviors (↓food-related cravings & impulsivity, ↑ self-efficacy) consistent with EI reduction. Changes in appetite regulation indices will be associated with changes in relevant brain networks (Aim 1). These changes will also be associated with ↓ ad libitum EI.
Exploratory Aim: To determine if RT impacts neuronal function and appetite-related peptides and behaviors in a manner favoring ↓ EI in Non-Compensators (top tertile of fat mass loss) as compared to Compensators (bottom tertile of fat mass loss).
Hypothesis: Compared to Compensators, Non-Compensators will show ↓ neuronal responses to food cues and default network, and changes in appetite-related peptides, ratings, and behaviors consistent with ↓ EI.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- University of Colorado Denver - Anschutz Medical Campus
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- all ethnic groups
- both sexes
- age: 18-55
- BMI: 27-40 kg/m2
- weight stable (±5% in last 6 months)
- sedentary (<2 hours of planned physical activity/week by self-report, no RT in previous 12-months)
Exclusion Criteria:
- history of CVD
- DM
- uncontrolled Hypertension
- untreated thyroid disease
- renal disease
- hepatic disease
- other condition affecting weight/metabolism
- unable to exercise
- smoker
- medications affecting weight
- EI or EE in past 6 months
- weight loss/gain >5% in past 6 months
- post-menopausal women (defined as age appropriate women with 6 months or more of amenorrhea)
- currently pregnant, lactating, < 6 months post-partum
- woman who have undergone oophorectomy
- bariatric surgery
- major psychiatric disorder
- alcohol or substance abuse
- depression by history and/or score >21 on CES-D
- history of eating disorders and/or score >20 on EATS-26
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: All Participants
12-weeks of a full body resistance training intervention.
Intervention will consist of 4 training sessions per week that are approximately 45-minutes in length.
Two days will be upper body training and 2 days lower body
|
12-weeks of a full body resistance training intervention.
Intervention will consist of 4 training sessions per week that are approximately 45-minutes in length.
Two days will be upper body training and 2 days lower body
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Neuronal Responses to Food Cues in Regions of Interest
Time Frame: Baseline, 12 Weeks
|
Changes in the insula, prefrontal cortex, and hypothalamus response to salient food cues (pre vs post-RT) as measured by fMRI in response to 12-weeks of RT
|
Baseline, 12 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Whole Brain Response
Time Frame: Baseline, 12 Weeks
|
Whole brain changes in response to salient food cues (pre vs post RT) as measured by fMRI in response to 12-weeks of RT
|
Baseline, 12 Weeks
|
Change in Default Mode Network
Time Frame: Baseline, 12 Weeks
|
Changes in the DMN resting state activity and large-scale network connectivity (pre vs post RT) as measured by MRI in response to 12-weeks of RT
|
Baseline, 12 Weeks
|
Changes in Appetite Ratings
Time Frame: Baseline, 12 Weeks
|
Changes in measures of appetite (hunger, satiety, and prospective food consumption) area under the curve [AUC] following a standardized test-meal in response to 12-weeks of RT.
|
Baseline, 12 Weeks
|
Changes in Appetite-Related Hormones
Time Frame: Baseline, 12 Weeks
|
Changes in appetite-related hormones [ghrelin, PYY, and GLP-1] area under the curve [AUC] following a standardized test meal in response to 12-weeks of RT.
|
Baseline, 12 Weeks
|
Change in In Lab Ad Libitum Energy Intake (kcals)
Time Frame: Baseline, 12 Weeks
|
Change in In lab ad libitum buffet lunch (via weigh and measure methodology) three hours after breakfast test meal at baseline and post-intervention
|
Baseline, 12 Weeks
|
Change in Free-Living Ad libitum Energy Intake (kcals)
Time Frame: Baseline, 12 Weeks
|
Change in Three days of free-living ad libitum energy intake (via DHQ food frequency questionnaire) at baseline and post intervention.
|
Baseline, 12 Weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Free-Living Physical Activity and Sedentary Time
Time Frame: Baseline, 12 Weeks
|
Physical Activity and Sedentary Time will be measured via activPAL (PALTechnologies: Glasgow, Scotland) activity monitor.
Participants will be instructed to wear the monitor on their right leg for 7 consecutive days at all times except when sleeping or participating in water-based activities (e.g.
showering, swimming).
The time-stamped "event" data file from the activPAL software will be used to determine time spent sitting/lying, standing and stepping per day.
|
Baseline, 12 Weeks
|
Changes in Muscular Strength
Time Frame: Baseline, 12 Weeks
|
Muscular Strength via 10 repetition maximum of chest and leg press on strength training machines, respectively.
|
Baseline, 12 Weeks
|
Change in Body Mass (kg)
Time Frame: Baseline, 12 Weeks
|
Via Digital scale
|
Baseline, 12 Weeks
|
Change in Body Composition
Time Frame: Baseline, 12 Weeks
|
Assessment of fat mass and lean mass via DXA scan
|
Baseline, 12 Weeks
|
Change in Neuronal Responses to Food Cues in Regions of Interest by Non-Compensator vs. Compensator groups
Time Frame: Baseline, 12 Weeks
|
Changes in the insula, prefrontal cortex, and hypothalamus response to salient food cues (pre vs post-RT) as measured by fMRI in response to 12-weeks of RT. "Non-Compensators" (will be defined as those who lose weight in response to the 12-week resistance training intervention.
"Compensators" will be defined as those who maintain or gain weight in response to the 12-week resistance training interventions.
|
Baseline, 12 Weeks
|
Change in Neuronal Responses to Food Cues in Regions of Interest by Sex
Time Frame: Baseline, 12 Weeks
|
Changes in the insula, prefrontal cortex, and hypothalamus response to salient food cues (pre vs post-RT) as measured by fMRI in response to 12-weeks of RT.
|
Baseline, 12 Weeks
|
Change in Whole Brain Response by Non-Compensator vs. Compensator groups
Time Frame: Baseline, 12 Weeks
|
Whole brain changes in response to salient food cues (pre vs post RT) as measured by fMRI in response to 12-weeks of RT. "Non-Compensators" (will be defined as those who lose weight in response to the 12-week resistance training intervention.
"Compensators" will be defined as those who maintain or gain weight in response to the 12-week resistance training interventions.
|
Baseline, 12 Weeks
|
Change in Whole Brain Response by Sex
Time Frame: Baseline, 12 Weeks
|
Whole brain changes in response to salient food cues (pre vs post RT) as measured by fMRI in response to 12-weeks of RT.
|
Baseline, 12 Weeks
|
Change in Default Mode Network by Non-Compensator vs. Compensator groups
Time Frame: Baseline, 12 Weeks
|
Changes in the DMN resting state activity and large-scale network connectivity (pre vs post RT) as measured by MRI in response to 12-weeks of RT. "Non-Compensators" (will be defined as those who lose weight in response to the 12-week resistance training intervention.
"Compensators" will be defined as those who maintain or gain weight in response to the 12-week resistance training interventions.
|
Baseline, 12 Weeks
|
Change in Default Mode Network by Sex
Time Frame: Baseline, 12 Weeks
|
Changes in the DMN resting state activity and large-scale network connectivity (pre vs post RT) as measured by MRI in response to 12-weeks of RT.
|
Baseline, 12 Weeks
|
Changes in Appetite Ratings by Non-Compensator vs. Compensator groups
Time Frame: Baseline, 12 Weeks
|
Changes in measures of appetite (hunger, satiety, and prospective food consumption) area under the curve [AUC] following a standardized test-meal in response to 12-weeks of RT. "Non-Compensators" (will be defined as those who lose weight in response to the 12-week resistance training intervention.
"Compensators" will be defined as those who maintain or gain weight in response to the 12-week resistance training interventions.
|
Baseline, 12 Weeks
|
Changes in Appetite Ratings by Sex
Time Frame: Baseline, 12 Weeks
|
Changes in measures of appetite (hunger, satiety, and prospective food consumption) area under the curve [AUC] following a standardized test-meal in response to 12-weeks of RT. "
|
Baseline, 12 Weeks
|
Changes in Appetite-Related Hormones by Non-Compensator vs. Compensator groups
Time Frame: Baseline, 12 Weeks
|
Changes in appetite-related hormones [ghrelin, PYY, and GLP-1] area under the curve [AUC] following a standardized test meal in response to 12-weeks of RT. "Non-Compensators" (will be defined as those who lose weight in response to the 12-week resistance training intervention.
"Compensators" will be defined as those who maintain or gain weight in response to the 12-week resistance training interventions.
|
Baseline, 12 Weeks
|
Changes in Appetite-Related Hormones by Sex
Time Frame: Baseline, 12 Weeks
|
Changes in appetite-related hormones [ghrelin, PYY, and GLP-1] area under the curve [AUC] following a standardized test meal in response to 12-weeks of RT.
|
Baseline, 12 Weeks
|
Change in In Lab Ad Libitum Energy Intake (kcals) by Non-Compensator vs. Compensator groups
Time Frame: Baseline, 12 Weeks
|
Change in In lab ad libitum buffet lunch (via weigh and measure methodology) three hours after breakfast test meal at baseline and post-intervention.
"Non-Compensators" (will be defined as those who lose weight in response to the 12-week resistance training intervention.
"Compensators" will be defined as those who maintain or gain weight in response to the 12-week resistance training interventions.
|
Baseline, 12 Weeks
|
Change in In Lab Ad Libitum Energy Intake (kcals) by Sex
Time Frame: Baseline, 12 Weeks
|
Change in In lab ad libitum buffet lunch (via weigh and measure methodology) three hours after breakfast test meal at baseline and post-intervention.
|
Baseline, 12 Weeks
|
Change in Free-Living Ad libitum Energy Intake (kcals) by Non-Compensator vs. Compensator groups
Time Frame: Baseline, 12 Weeks
|
Change in Three days of free-living ad libitum energy intake (via DHQ food frequency questionnaire) at baseline and post intervention.
"Non-Compensators" (will be defined as those who lose weight in response to the 12-week resistance training intervention.
"Compensators" will be defined as those who maintain or gain weight in response to the 12-week resistance training interventions.
|
Baseline, 12 Weeks
|
Change in Free-Living Ad libitum Energy Intake (kcals) by Sex
Time Frame: Baseline, 12 Weeks
|
Change in Three days of free-living ad libitum energy intake (via DHQ food frequency questionnaire) at baseline and post intervention.
|
Baseline, 12 Weeks
|
Changes in Free-Living Physical Activity and Sedentary Time by Non-Compensator vs. Compensator groups
Time Frame: Baseline, 12 Weeks
|
Physical Activity and Sedentary Time will be measured via activPAL (PALTechnologies: Glasgow, Scotland) activity monitor.
Participants will be instructed to wear the monitor on their right leg for 7 consecutive days at all times except when sleeping or participating in water-based activities (e.g.
showering, swimming).
The time-stamped "event" data file from the activPAL software will be used to determine time spent sitting/lying, standing and stepping per day.
"Non-Compensators" (will be defined as those who lose weight in response to the 12-week resistance training intervention.
"Compensators" will be defined as those who maintain or gain weight in response to the 12-week resistance training interventions.
|
Baseline, 12 Weeks
|
Changes in Free-Living Physical Activity and Sedentary Time by Sex
Time Frame: Baseline, 12 Weeks
|
Physical Activity and Sedentary Time will be measured via activPAL (PALTechnologies: Glasgow, Scotland) activity monitor.
Participants will be instructed to wear the monitor on their right leg for 7 consecutive days at all times except when sleeping or participating in water-based activities (e.g.
showering, swimming).
The time-stamped "event" data file from the activPAL software will be used to determine time spent sitting/lying, standing and stepping per day.
|
Baseline, 12 Weeks
|
Change in Muscular Strength by Non-Compensators vs Compensators
Time Frame: Baseline, 12 Weeks
|
Muscular Strength via 10 repetition maximum of chest and leg press on strength training machines, respectively.
"Non-Compensators" (will be defined as those who lose weight in response to the 12-week resistance training intervention.
"Compensators" will be defined as those who maintain or gain weight in response to the 12-week resistance training interventions.
|
Baseline, 12 Weeks
|
Change in Muscular Strength by Sex
Time Frame: Baseline, 12 Weeks
|
Muscular Strength via 10 repetition maximum of chest and leg press on strength training machines, respectively.
|
Baseline, 12 Weeks
|
Change in Body Mass by Non-Compensator vs. Compensator groups
Time Frame: Baseline, 12 Weeks
|
Via Digital scale.
"Non-Compensators" (will be defined as those who lose weight in response to the 12-week resistance training intervention.
"Compensators" will be defined as those who maintain or gain weight in response to the 12-week resistance training interventions.
|
Baseline, 12 Weeks
|
Change in Body Mass by Sex
Time Frame: Baseline, 12 Weeks
|
Via Digital scale.
|
Baseline, 12 Weeks
|
Change in Body Composition by Non-Compensator vs. Compensator groups
Time Frame: Baseline, 12 Weeks
|
Assessment of fat mass and lean mass via DXA scan.
"Non-Compensators" (will be defined as those who lose weight in response to the 12-week resistance training intervention.
"Compensators" will be defined as those who maintain or gain weight in response to the 12-week resistance training interventions.
|
Baseline, 12 Weeks
|
Change in Body Composition by Sex
Time Frame: Baseline, 12 Weeks
|
Assessment of fat mass and lean mass via DXA scan.
|
Baseline, 12 Weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 18-1298
- 1R21DK115200-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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