Resistance Training Effects on Gut Microbiome and Cardiom... | NCT04906525

Studies
Resistance Training Effects on Gut Microbiome and Cardiometabolic Outcomes

NCT04906525

Sponsor

University of Missouri-Columbia

Status

Completed

Last Update Posted

Mar 13, 2023Actual

Enrollment

34Actual

Phase

Not Applicable

Conditions

Exercise Intervention

Interventions

Resistance training
Conventional physical activity guidelines

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 19, 2021Actual

Primary Completion Date

Sep 30, 2022Actual

Completion Date

Sep 30, 2022Actual

First Submitted Date

May 5, 2021

First Submission Date that Met QC Criteria

May 24, 2021

First Posted Date

May 28, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2023

Last Update Posted Date

Mar 13, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jaapna Dhillon, Assistant Professor, University of Missouri-ColumbiaPrincipal Investigator

Lead Sponsor

University of Missouri-ColumbiaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Conventional physical activity guidelines	Other	Participants are given recommendations on physical activity guidelines	Other: Conventional physical activity guidelines
Resistance training	Experimental	Participants will undergo 6 weeks of supervised resistance training	Behavioral: Resistance training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Resistance training	Behavioral	Participants will undergo 6 weeks of supervised resistance training	Resistance training

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in stool microbiome diversity	16s rRNA sequencing	Change over 6 weeks
Change in stool microbiome composition	16s rRNA sequencing	Change over 6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change in blood pressure	diastolic and systolic blood pressure	change over 6 weeks
Fat mass	body composition	Change over 6 weeks

Other Outcomes

Measure	Description	Time Frame
Food environment perceptions	subjective and objective questionnaires	baseline and at the end of 6 week intervention

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jaapna Dhillon, PhD	University of Missouri-Columbia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Missouri		Columbia	Missouri	65211	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Individual participant data that underlie the results reported here after deidentification (text, tables, figures, etc.)

Types

Study Protocol
Informed Consent Form (ICF)

Time Frame

Immediately following publication. No end date.

Access Criteria

Data will be deposited in online data repositories.

URL

Not provided

ID	Term
D009043	Motor Activity

ID	Term
D001519	Behavior

Intervention Browse Module

MeSH Terms

ID	Term
D055070	Resistance Training

Ancestor Terms

ID	Term
D005081	Exercise Therapy
D012046	Rehabilitation
D000359	Aftercare
D003266	Continuity of Patient Care

Browse Leaves

Not provided

Browse Branches

Not provided