ObesityNCT04931836
The Influence of Physical Activity on the Gut Microbiome of Pre-Diabetic Adults
A study testing Physical Activity Intervention in people with Obesity and Overweight, run by University of Minnesota at 1 site in United States.
Trial summary
The present study is a 100-participant randomized controlled 2-arm parallel trial that employs a metagenomic approach to examine how 8 weeks of supervised moderate-intensity treadmill walking exercise (MWE) for 30-45 min 3 times/week alters the gut microbiome, serum short chain fatty acids, and the cardiometabolic… Read more about this study
- Who is it for?
- Ages 30 to 64 years
- Conditions the study is for
- Obesity, Overweight, Overweight and Obesity
- What is being tested?
- Physical Activity Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2021to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Classified as overweight or obese with BMI 25.0-39.9 kg/m2.
- Documentation* of a prediabetes diagnosis within one year of enrollment by physician or primary care provider based on lab tests showing a fasted blood glucose of 100-125 mg/dL, a 2-hour oral glucose tolerance test of 140-199 mg/dL, or an HbA1c level of 5.7%-6.4%76; OR a study screening lab value of HbA1C within the afore mentioned range.
- Currently engaged in <100 min/week of physical activity - confirmed by questionnaire.
- No exercise contraindications as assessed by the Physical Activity Readiness Questionnaire (PAR-Q)78-this Questionnaire involves seven "yes" or "no" questions regarding an individual's health status, with answering "yes" to any one of these questions requiring a prospective participant to acquire a written doctor's note stating they can safely participate in the trial's exercise intervention.
- No self-reported physical/mental disabilities or gastrointestinal conditions.
- No antibiotic usage within the last 45 days.
Show all 10Show fewer
- Stable weight over the last 6 months (<10% change).
- Not currently pregnant, planning to become pregnant, or currently breastfeeding.
- Willing to maintain current dietary and exercise habits, aside from any changes to be made per the study exercise protocol.
- Note: Documentation can include either a print out or screen shot of the lab value illustrating eligibility, along with the date of the test and the participant's name. If a hard copy is provided, the date and name will be redacted.
Who cannot join
- Self-reported use of metformin and/or other medications that could interfere with the primary outcome.
- History of bariatric surgery or a history of other medical interventions that would interfere with the primary outcome.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
The present study is a 100-participant randomized controlled 2-arm parallel trial that employs a metagenomic approach to examine how 8 weeks of supervised moderate-intensity treadmill walking exercise (MWE) for 30-45 min 3 times/week alters the gut microbiome, serum short chain fatty acids, and the cardiometabolic profile, body weight, and body composition of individuals 30-64 years old who have overweight or obesity and have prediabetes.
Read the detailed description
All eligible and consented participants will complete a 3-week run-in phase during which baseline outcome assessments will be performed. During run-in weeks 1 and 2, participants will wear a Fitbit Inspire 2 smartwatch and complete three unannounced dietary recalls. During the run-in week 3 (see table below), participants will consume their 3-day standardized meal plan on days three through five, obtain a fecal sample, complete a study questionnaire, and complete a study assessment visit. To quantify compliance with the 3-day meal plan, participants will be provided with a paper checklist of all foods to be consumed, and will be asked to indicate which foods were consumed and to document any deviation. The study assessment visit will include a fasting blood draw (at baseline and week eight only), blood pressure in triplicate, weight measure and body fat assessment in duplicate, and a saliva sample.
- Conditions
- Obesity, Overweight, Overweight and Obesity, PreDiabetes, Type 2 Diabetes, Type 2 Diabetes Mellitus
- Being tested
- Physical Activity Intervention
- Keywords
- Microbiome, Physical Activity
- Medical subject headings
- Obesity, Overweight, Prediabetic State, Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity InterventionBehavioural
Three walking sessions/week for a total of 8 weeks (24 total sessions) - Walking sessions will either take place on new commercial treadmills in the Epidemiology Clinical Research Center or remotely at or around a participant's home. Regardless of the walking location, walking sessions will be 30 min in duration during intervention weeks 1 through 4 and a minimum of 45 min each during intervention weeks 5 through 8.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Participants in this group will complete the physical activity intervention. Receives: Behavioral: Physical Activity Intervention |
| Control Group | No intervention | Participants in this group will be asked to maintain their normal level of physical activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Shannon Index (Unitless)
Changes to the gut microbiome will be assessed via metagenomic sequencing, from pre- to post-intervention. The Shannon Index-a measure of microbial community diversity-will be the primary indicator for changes in gut microbiota composition, and will be assessed at baseline, and following the 4th and 8th weeks. Index values are unitless and range from 0 to 1. Lower values indicate more diversity while higher values indicate less diversity. Outcome will be reported at baseline, 4 weeks, and 8 weeks and as the change from baseline to 4 weeks and baseline to 8 weeks.
Measured: 8 weeks
Change in Serum Short Chain Fatty Acids (SCFA)
Participants will undergo fasted blood draws to assess serum SCFA levels. This work will be performed using the Metabolon pipeline. Outcome is reported as the sum of the serum concentrations of acetate, propionate, and butyrate in Z-score units. We report the Week 8 means and standard errors from a linear model adjusted for the Week 0 (baseline) values. The original units are reported in ng/mL and the final results are reported as standardized z-scores in which each value subtracts the mean and the difference is divided by the standard deviation. Higher values represent higher levels of SCFA which is considered better. The scale is in standard deviation units. A value of 0 = the population mean.
Measured: 8 weeks
Secondary outcomes (8)
High-density Lipoprotein Cholesterol (HDL-C)
High-density lipoprotein cholesterol (HDL-C) will be measured using standard laboratory test and report in units of mg/dl. We report the Week 8 means and standard errors from a linear model adjusted for the Week 0 (baseline) values.
Measured: 8 weeks
Triglycerides
Blood triglycerides will be measured using a standard laboratory test and reported in units of mg/dl. We report the Week 8 means and standard errors from a linear model adjusted for the Week 0 (baseline) values.
Measured: 8 weeks
Fasting Insulin
Fasting insulin will be measured by laboratory test and reported in units of pm/ml. We report the Week 8 means and standard errors from a linear model adjusted for the Week 0 (baseline) values.
Measured: 8 weeks
Fasting Glucose
Fasting glucose will be measured by standard laboratory test and reported in units of mg/dl. We report the Week 8 means and standard errors from a linear model adjusted for the Week 0 (baseline) values.
Measured: 8 weeks
C-reactive Protein (CRP)
C-reactive protein (CRP) will be measured by laboratory test and reported in units of mg/l. We report the Week 8 means and standard errors from a linear model adjusted for the Week 0 (baseline) values.
Measured: 8 weeks
Resting Systolic Blood Pressure (BP)
Resting systolic blood pressure will be reported in units of mmHg. We report the Week 8 means and standard errors from a linear model adjusted for the Week 0 (baseline) values.
Measured: 8 weeks
Body Composition
Body composition will be analyzed using bioelectrical impedance. Outcome will be reported as percent body fat. We report the Week 8 means and standard errors from a linear model adjusted for the Week 0 (baseline) values.
Measured: 8 weeks
Cardiometabolic Risk Score (CMR)
The Cardiometabolic Risk Score (CMR) is the mean Z-score across systolic blood pressure, glucose, insulin, HDL, % body fat, and triglycerides. We report the Week 8 means and standard errors from a linear model adjusted for the Week 0 (baseline) values. The final results are reported as standardized z-scores in which each value subtracts the mean and the difference is divided by the standard deviation. Higher values represent higher levels of cardiometabolic risk which is considered worse. The scale is in standard deviation units. A value of 0 = the population mean.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start29 Jul 2021
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryan Demmer, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04931836
- Sponsor's protocol ID
- STUDY00009136
- Status last verified
- Jun 2025
- First submitted
- 11 Jun 2021
- Last updated
- 13 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Physical Activity on the Gut Microbiome of Pre-Diabetic Adults
- ClinicalTrials.gov ID
- NCT04931836
- Acronym / sponsor ID
- STUDY00009136
- Conditions
- Obesity, Overweight, Overweight and Obesity, PreDiabetes, Type 2 Diabetes, Type 2 Diabetes Mellitus
- Keywords
- Microbiome, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 29 Jul 2021 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 18 Jun 2021 (actual)
- Results
- Posted 13 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study is a 100-participant randomized controlled 2-arm parallel trial that employs a metagenomic approach to examine how 8 weeks of supervised moderate-intensity treadmill walking exercise (MWE) for 30-45 min 3 times/week alters the gut microbiome, serum short chain fatty acids, and the cardiometabolic profile, body weight, and body composition of individuals 30-64 years old who have overweight or obesity and have prediabetes.
Detailed description
All eligible and consented participants will complete a 3-week run-in phase during which baseline outcome assessments will be performed. During run-in weeks 1 and 2, participants will wear a Fitbit Inspire 2 smartwatch and complete three unannounced dietary recalls. During the run-in week 3 (see table below), participants will consume their 3-day standardized meal plan on days three through five, obtain a fecal sample, complete a study questionnaire, and complete a study assessment visit. To quantify compliance with the 3-day meal plan, participants will be provided with a paper checklist of all foods to be consumed, and will be asked to indicate which foods were consumed and to document any deviation. The study assessment visit will include a fasting blood draw (at baseline and week eight only), blood pressure in triplicate, weight measure and body fat assessment in duplicate, and a saliva sample.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Physical Activity InterventionParticipants in this group will complete the physical activity intervention. |
| Control Group | No intervention | –Participants in this group will be asked to maintain their normal level of physical activity. |
Who may qualify
- Ages
- 30 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Classified as overweight or obese with BMI 25.0-39.9 kg/m2.
- Documentation* of a prediabetes diagnosis within one year of enrollment by physician or primary care provider based on lab tests showing a fasted blood glucose of 100-125 mg/dL, a 2-hour oral glucose tolerance test of 140-199 mg/dL, or an HbA1c level of 5.7%-6.4%76; OR a study screening lab value of HbA1C within the afore mentioned range.
- Currently engaged in <100 min/week of physical activity - confirmed by questionnaire.
- No exercise contraindications as assessed by the Physical Activity Readiness Questionnaire (PAR-Q)78-this Questionnaire involves seven "yes" or "no" questions regarding an individual's health status, with answering "yes" to any one of these questions requiring a prospective participant to acquire a written doctor's note stating they can safely participate in the trial's exercise intervention.
- No self-reported physical/mental disabilities or gastrointestinal conditions.
Key exclusion criteria (2 listed)
- Self-reported use of metformin and/or other medications that could interfere with the primary outcome.
- History of bariatric surgery or a history of other medical interventions that would interfere with the primary outcome.
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 |
|---|---|---|
| Physical Activity InterventionThree walking sessions/week for a total of 8 weeks (24 total sessions) - Walking sessions will either take place on new commercial treadmills in the Epidemiology Clinical Research Center or remotely at or around a participant's home. Regardless of the walking location, walking sessions will be 30 min in duration during intervention weeks 1 through 4 and a minimum of 45 min each during intervention weeks 5 through 8. | Behavioural | Experimental Group |
Primary outcome
Change in Shannon Index (Unitless)
Time frame: 8 weeks
Changes to the gut microbiome will be assessed via metagenomic sequencing, from pre- to post-intervention. The Shannon Index-a measure of microbial community diversity-will be the primary indicator for changes in gut microbiota composition, and will be assessed at baseline, and following the 4th and 8th weeks. Index values are unitless and range from 0 to 1. Lower values indicate more diversity while higher values indicate less diversity. Outcome will be reported at baseline, 4 weeks, and 8 weeks and as the change from baseline to 4 weeks and baseline to 8 weeks.
Change in Serum Short Chain Fatty Acids (SCFA)
Time frame: 8 weeks
Participants will undergo fasted blood draws to assess serum SCFA levels. This work will be performed using the Metabolon pipeline. Outcome is reported as the sum of the serum concentrations of acetate, propionate, and butyrate in Z-score units. We report the Week 8 means and standard errors from a linear model adjusted for the Week 0 (baseline) values. The original units are reported in ng/mL and the final results are reported as standardized z-scores in which each value subtracts the mean and the difference is divided by the standard deviation. Higher values represent higher levels of SCFA which is considered better. The scale is in standard deviation units. A value of 0 = the population mean.
8 secondary outcomes
High-density Lipoprotein Cholesterol (HDL-C)
Time frame: 8 weeks
Triglycerides
Time frame: 8 weeks
Fasting Insulin
Time frame: 8 weeks
Fasting Glucose
Time frame: 8 weeks
C-reactive Protein (CRP)
Time frame: 8 weeks
Resting Systolic Blood Pressure (BP)
Time frame: 8 weeks
Body Composition
Time frame: 8 weeks
Cardiometabolic Risk Score (CMR)
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ryan Demmer, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity Intervention in people with Obesity and Overweight, run by University of Minnesota 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 10 inclusion and 2 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 Jun 2025. 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?
Yes. Results are posted in the registry (first posted 13 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Shannon Index (Unitless) (time frame: 8 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 Jun 2025.