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Resistance Training and Appetite Regulation

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ClinicalTrials.gov Identifier: NCT03985787
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
This study plans to learn more about how resistance training impacts appetite and the brain's response to food. The study will be evaluating how the brain responds to food images as well as how behaviors and hormones change with a 12 week resistance training intervention.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Resistance Training Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Effects of Resistance Training on Appetite Regulation
Actual Study Start Date : October 24, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : January 2021

Arm Intervention/treatment
Experimental: All Participants Behavioral: Resistance Training
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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

  6. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. Change in Body Mass (kg) [ Time Frame: Baseline, 12 Weeks ]
    Via Digital scale

  4. Change in Body Composition [ Time Frame: Baseline, 12 Weeks ]
    Assessment of fat mass and lean mass via DXA scan

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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. "

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. Change in Body Mass by Sex [ Time Frame: Baseline, 12 Weeks ]
    Via Digital scale.

  25. 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.

  26. Change in Body Composition by Sex [ Time Frame: Baseline, 12 Weeks ]
    Assessment of fat mass and lean mass via DXA scan.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03985787


Contacts
Layout table for location contacts
Contact: Tanya M Halliday, PhD 303-724-9024 tanya.halliday@ucdenver.edu
Contact: Allison Hild, BS allison.hild@ucdenver.edu

Locations
Layout table for location information
United States, Colorado
University of Colorado Denver - Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Tanya M Halliday, PhD, RD    303-724-9024    tanya.halliday@ucdenver.edu   
Contact: Allison Hild, BS       allison.hild@ucdenver.edu   
Principal Investigator: Marc A Cornier, MD         
Sub-Investigator: Tanya M Halliday, PhD, RD         
Sub-Investigator: Jason R Tregellas, PhD         
Sponsors and Collaborators
University of Colorado, Denver
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03985787     History of Changes
Other Study ID Numbers: 18-1298
1R21DK115200-01A1 ( U.S. NIH Grant/Contract )
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Colorado, Denver:
Resistance Exercise
Appetite Regulation