- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04906525
Resistance Training Effects on Gut Microbiome and Cardiometabolic Outcomes
March 9, 2023 updated by: Jaapna Dhillon, University of Missouri-Columbia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
34
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
-
Columbia, Missouri, United States, 65211
- University of Missouri
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Gastrointestinal disease and/or bariatric surgery
- Smoking
- Illicit drug use
- Pregnant or lactating individuals
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Conventional physical activity guidelines
Participants are given recommendations on physical activity guidelines
|
Participants are given recommendations on physical activity guidelines
|
Experimental: Resistance training
Participants will undergo 6 weeks of supervised resistance training
|
Participants will undergo 6 weeks of supervised resistance training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in stool microbiome diversity
Time Frame: Change over 6 weeks
|
16s rRNA sequencing
|
Change over 6 weeks
|
Change in stool microbiome composition
Time Frame: Change over 6 weeks
|
16s rRNA sequencing
|
Change over 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in blood pressure
Time Frame: change over 6 weeks
|
diastolic and systolic blood pressure
|
change over 6 weeks
|
Fat mass
Time Frame: Change over 6 weeks
|
body composition
|
Change over 6 weeks
|
Fat free mass
Time Frame: Change over 6 weeks
|
body composition
|
Change over 6 weeks
|
Change in fasting glucose
Time Frame: change over 6 weeks
|
Fasting Glucose
|
change over 6 weeks
|
Change in glucose regulation
Time Frame: change over 6 weeks
|
2 hour glucose clearance
|
change over 6 weeks
|
Hip circumference
Time Frame: change over 6 weeks
|
anthropometrics
|
change over 6 weeks
|
Waist circumference
Time Frame: change over 6 weeks
|
anthropometrics
|
change over 6 weeks
|
Physical activity
Time Frame: change over 6 weeks
|
kcalories burned during free living activity measured by accelerometer
|
change over 6 weeks
|
Sleep Quality
Time Frame: change over 6 weeks
|
Measured using actigraphs
|
change over 6 weeks
|
Sleep Duration
Time Frame: change over 6 weeks
|
Measured using actigraphs
|
change over 6 weeks
|
24hr appetite ratings
Time Frame: Once at baseline and at the end of 6 week intervention
|
Subjective rating using visual analog scales
|
Once at baseline and at the end of 6 week intervention
|
Change in Body mass
Time Frame: change over 6 weeks
|
Measured in kg
|
change over 6 weeks
|
Short chain fatty acids
Time Frame: Change over 6 weeks
|
Acetate, propionate, and butyrate
|
Change over 6 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Food environment perceptions
Time Frame: baseline and at the end of 6 week intervention
|
subjective and objective questionnaires
|
baseline and at the end of 6 week intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jaapna Dhillon, PhD, University of Missouri-Columbia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 19, 2021
Primary Completion (Actual)
September 30, 2022
Study Completion (Actual)
September 30, 2022
Study Registration Dates
First Submitted
May 5, 2021
First Submitted That Met QC Criteria
May 24, 2021
First Posted (Actual)
May 28, 2021
Study Record Updates
Last Update Posted (Actual)
March 13, 2023
Last Update Submitted That Met QC Criteria
March 9, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 2054484
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Individual participant data that underlie the results reported here after deidentification (text, tables, figures, etc.)
IPD Sharing Time Frame
Immediately following publication.
No end date.
IPD Sharing Access Criteria
Data will be deposited in online data repositories.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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