Resistance Training and Appetite Regulation

Obesity Clinical Trial

Official title:

The Effects of Resistance Training on Appetite Regulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03985787
• Other study ID #: 18-1298
• Secondary ID: 1R21DK115200-01A
• Status: Completed
• Phase: N/A
• Start date: October 24, 2018
• Est. completion date: May 31, 2021

Study information

• Verified date: September 2021
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

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

Locations

Country	Name	City	State
United States	University of Colorado Denver - Anschutz Medical Campus	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in Free-Living Physical Activity and Sedentary Time	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
Other	Changes in Muscular Strength	Muscular Strength via 10 repetition maximum of chest and leg press on strength training machines, respectively.	Baseline, 12 Weeks
Other	Change in Body Mass (kg)	Via Digital scale	Baseline, 12 Weeks
Other	Change in Body Composition	Assessment of fat mass and lean mass via DXA scan	Baseline, 12 Weeks
Other	Change in Neuronal Responses to Food Cues in Regions of Interest by Non-Compensator vs. Compensator groups	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
Other	Change in Neuronal Responses to Food Cues in Regions of Interest by Sex	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
Other	Change in Whole Brain Response by Non-Compensator vs. Compensator groups	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
Other	Change in Whole Brain Response by Sex	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
Other	Change in Default Mode Network by Non-Compensator vs. Compensator groups	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
Other	Change in Default Mode Network by Sex	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
Other	Changes in Appetite Ratings by Non-Compensator vs. Compensator groups	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
Other	Changes in Appetite Ratings by Sex	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
Other	Changes in Appetite-Related Hormones by Non-Compensator vs. Compensator groups	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
Other	Changes in Appetite-Related Hormones by Sex	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
Other	Change in In Lab Ad Libitum Energy Intake (kcals) by Non-Compensator vs. Compensator groups	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
Other	Change in In Lab Ad Libitum Energy Intake (kcals) by Sex	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
Other	Change in Free-Living Ad libitum Energy Intake (kcals) by Non-Compensator vs. Compensator groups	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
Other	Change in Free-Living Ad libitum Energy Intake (kcals) by Sex	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	Changes in Free-Living Physical Activity and Sedentary Time by Non-Compensator vs. Compensator groups	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
Other	Changes in Free-Living Physical Activity and Sedentary Time by Sex	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
Other	Change in Muscular Strength by Non-Compensators vs Compensators	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
Other	Change in Muscular Strength by Sex	Muscular Strength via 10 repetition maximum of chest and leg press on strength training machines, respectively.	Baseline, 12 Weeks
Other	Change in Body Mass by Non-Compensator vs. Compensator groups	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
Other	Change in Body Mass by Sex	Via Digital scale.	Baseline, 12 Weeks
Other	Change in Body Composition by Non-Compensator vs. Compensator groups	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
Other	Change in Body Composition by Sex	Assessment of fat mass and lean mass via DXA scan.	Baseline, 12 Weeks
Primary	Change in Neuronal Responses to Food Cues in Regions of Interest	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	Change in Whole Brain Response	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
Secondary	Change in Default Mode Network	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
Secondary	Changes in Appetite Ratings	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
Secondary	Changes in Appetite-Related Hormones	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
Secondary	Change in In Lab Ad Libitum Energy Intake (kcals)	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
Secondary	Change in Free-Living Ad libitum Energy Intake (kcals)	Change in Three days of free-living ad libitum energy intake (via DHQ food frequency questionnaire) at baseline and post intervention.	Baseline, 12 Weeks