ObesityNCT03985787
Resistance Training and Appetite Regulation
A study testing Resistance Training in people with Obesity, run by University of Colorado, Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Resistance Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2018to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- history of CVD
- DM
- uncontrolled Hypertension
- untreated thyroid disease
- renal disease
- hepatic disease
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver - Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: The Effects of Resistance Training on Appetite Regulation
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Resistance Training
- Keywords
- Resistance Exercise, Appetite Regulation
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance TrainingBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Experimental | 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 Receives: Behavioral: Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 12 Weeks
Secondary outcomes (6)
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
Measured: Baseline, 12 Weeks
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
Measured: Baseline, 12 Weeks
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.
Measured: Baseline, 12 Weeks
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.
Measured: Baseline, 12 Weeks
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
Measured: Baseline, 12 Weeks
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.
Measured: Baseline, 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start24 Oct 2018
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc-Andre Cornier, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03985787
- Sponsor's protocol ID
- 18-1298
- Other IDs
- 1R21DK115200-01A1
- Status last verified
- Sep 2021
- First submitted
- 11 Apr 2019
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Resistance Training on Appetite Regulation
- ClinicalTrials.gov ID
- NCT03985787
- Acronym / sponsor ID
- 18-1298
- Conditions
- Obesity
- Keywords
- Resistance Exercise, Appetite Regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 24 Oct 2018 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 14 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | Experimental | Behavioral: Resistance Training12-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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- all ethnic groups
- both sexes
- age: 18-55
- BMI: 27-40 kg/m2
- weight stable (±5% in last 6 months)
Key exclusion criteria (20 listed)
- history of CVD
- DM
- uncontrolled Hypertension
- untreated thyroid disease
- renal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance Training12-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 | Behavioural | All Participants |
Primary outcome
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
6 secondary outcomes
Change in Whole Brain Response
Time frame: Baseline, 12 Weeks
Change in Default Mode Network
Time frame: Baseline, 12 Weeks
Changes in Appetite Ratings
Time frame: Baseline, 12 Weeks
Changes in Appetite-Related Hormones
Time frame: Baseline, 12 Weeks
Change in In Lab Ad Libitum Energy Intake (kcals)
Time frame: Baseline, 12 Weeks
Change in Free-Living Ad libitum Energy Intake (kcals)
Time frame: Baseline, 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc-Andre Cornier, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Training in people with Obesity, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Neuronal Responses to Food Cues in Regions of Interest (time frame: Baseline, 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.