Exercise InterventionNCT04906525
Resistance Training Effects on Gut Microbiome and Cardiometabolic Outcomes
A study testing Resistance training and Conventional physical activity guidelines in people with Exercise Intervention, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
The overall objective of this study is to investigate the effects of resistance training on the gut microbiome and cardiometabolic outcomes in adults with overweight and obesity. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Intervention
- What is being tested?
- Resistance training and Conventional physical activity guidelines
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2021to 30 Sep 2022
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-35 years
- BMI: 25-45 kg/m2
- Sedentary lifestyle
- Consistent diet patterns
- Weight-stable (<4 kg change over the last 3 mo)
- Willingness to adhere to resistance training protocol and not change diet
- Non-smoker >1 year or more
Who cannot join
- Disabilities preventing adherence to resistance training protocol
- Recent start of medications that affect metabolism or appetite
- Antibiotics
- Diabetes
- Drug therapy for coronary artery disease, peripheral artery disease, congestive heart failure, or dyslipidemia
- Uncontrolled hypertension and blood pressure ≥ 180/110
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- Gastrointestinal disease and/or bariatric surgery
- Smoking
- Illicit drug use
- Pregnant or lactating individuals
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of 6-week Resistance Training Intervention on Gut Microbiome and Cardiometabolic Outcomes in Adults With Overweight and Obesity
The overall objective of this study is to investigate the effects of resistance training on the gut microbiome and cardiometabolic outcomes in adults with overweight and obesity.
Read the detailed description
The overall objective of this study is to investigate the effects of resistance training on the gut microbiome and cardiometabolic outcomes in adults with overweight and obesity.
- Conditions
- Exercise Intervention
- Being tested
- Resistance training, Conventional physical activity guidelines
- Keywords
- Gut Microbiome, Resistance Training, Physical Activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance trainingBehavioural
Participants will undergo 6 weeks of supervised resistance training
Conventional physical activity guidelinesOther
Participants are given recommendations on physical activity guidelines
| Study group | Role | What they receive |
|---|---|---|
| Conventional physical activity guidelines | Other | Participants are given recommendations on physical activity guidelines Receives: Other: Conventional physical activity guidelines |
| Resistance training | Experimental | Participants will undergo 6 weeks of supervised resistance training Receives: Behavioral: Resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in stool microbiome diversity
16s rRNA sequencing
Measured: Change over 6 weeks
Change in stool microbiome composition
16s rRNA sequencing
Measured: Change over 6 weeks
Secondary outcomes (13)
Change in blood pressure
diastolic and systolic blood pressure
Measured: change over 6 weeks
Fat mass
body composition
Measured: Change over 6 weeks
Fat free mass
body composition
Measured: Change over 6 weeks
Change in fasting glucose
Fasting Glucose
Measured: change over 6 weeks
Change in glucose regulation
2 hour glucose clearance
Measured: change over 6 weeks
Hip circumference
anthropometrics
Measured: change over 6 weeks
Waist circumference
anthropometrics
Measured: change over 6 weeks
Physical activity
kcalories burned during free living activity measured by accelerometer
Measured: change over 6 weeks
Sleep Quality
Measured using actigraphs
Measured: change over 6 weeks
Sleep Duration
Measured using actigraphs
Measured: change over 6 weeks
24hr appetite ratings
Subjective rating using visual analog scales
Measured: Once at baseline and at the end of 6 week intervention
Change in Body mass
Measured in kg
Measured: change over 6 weeks
Short chain fatty acids
Acetate, propionate, and butyrate
Measured: Change over 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start19 May 2021
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise InterventionStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaapna Dhillon, University of Missouri-Columbia
- Investigators
- Jaapna Dhillon, PhD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04906525
- Sponsor's protocol ID
- 2054484
- Status last verified
- Mar 2023
- First submitted
- 5 May 2021
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported here after deidentification (text, tables, figures, etc.)
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 6-week Resistance Training Intervention on Gut Microbiome and Cardiometabolic Outcomes in Adults With Overweight and Obesity
- ClinicalTrials.gov ID
- NCT04906525
- Acronym / sponsor ID
- 2054484
- Conditions
- Exercise Intervention
- Keywords
- Gut Microbiome, Resistance Training, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 19 May 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 28 May 2021 (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.
The overall objective of this study is to investigate the effects of resistance training on the gut microbiome and cardiometabolic outcomes in adults with overweight and obesity.
Detailed description
The overall objective of this study is to investigate the effects of resistance training on the gut microbiome and cardiometabolic outcomes in adults with overweight and obesity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional physical activity guidelines | Other | Other: Conventional physical activity guidelinesParticipants are given recommendations on physical activity guidelines |
| Resistance training | Experimental | Behavioral: Resistance trainingParticipants will undergo 6 weeks of supervised resistance training |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 18-35 years
- BMI: 25-45 kg/m2
- Sedentary lifestyle
- Consistent diet patterns
- Weight-stable (<4 kg change over the last 3 mo)
Key exclusion criteria (10 listed)
- Disabilities preventing adherence to resistance training protocol
- Recent start of medications that affect metabolism or appetite
- Antibiotics
- Diabetes
- Drug therapy for coronary artery disease, peripheral artery disease, congestive heart failure, or dyslipidemia
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 trainingParticipants will undergo 6 weeks of supervised resistance training | Behavioural | Resistance training |
| Conventional physical activity guidelinesParticipants are given recommendations on physical activity guidelines | Other | Conventional physical activity guidelines |
Primary outcome
Change in stool microbiome diversity
Time frame: Change over 6 weeks
16s rRNA sequencing
Change in stool microbiome composition
Time frame: Change over 6 weeks
16s rRNA sequencing
13 secondary outcomes
Change in blood pressure
Time frame: change over 6 weeks
Fat mass
Time frame: Change over 6 weeks
Fat free mass
Time frame: Change over 6 weeks
Change in fasting glucose
Time frame: change over 6 weeks
Change in glucose regulation
Time frame: change over 6 weeks
Hip circumference
Time frame: change over 6 weeks
Waist circumference
Time frame: change over 6 weeks
Physical activity
Time frame: change over 6 weeks
Sleep Quality
Time frame: change over 6 weeks
Sleep Duration
Time frame: change over 6 weeks
24hr appetite ratings
Time frame: Once at baseline and at the end of 6 week intervention
Change in Body mass
Time frame: change over 6 weeks
Short chain fatty acids
Time frame: Change over 6 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 13 Mar 2023.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported here after deidentification (text, tables, figures, etc.)
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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.
Jaapna Dhillon, PhD principal investigator
University of Missouri-Columbia
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 and Conventional physical activity guidelines in people with Exercise Intervention, run by University of Missouri-Columbia 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 7 inclusion and 10 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 13 Mar 2023. 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 stool microbiome diversity (time frame: Change over 6 weeks). The study lists 2 primary outcomes in all. 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 13 Mar 2023.