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

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.

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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