NCT04906525

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2021

Completed
14 days until next milestone

Study Start

First participant enrolled

May 19, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 28, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

March 13, 2023

Status Verified

March 1, 2023

Enrollment Period

1.4 years

First QC Date

May 5, 2021

Last Update Submit

March 9, 2023

Conditions

Keywords

Gut MicrobiomeResistance TrainingPhysical Activity

Outcome Measures

Primary Outcomes (2)

  • 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 (13)

  • Change in blood pressure

    change over 6 weeks

  • Fat mass

    Change over 6 weeks

  • Fat free mass

    Change over 6 weeks

  • Change in fasting glucose

    change over 6 weeks

  • Change in glucose regulation

    change over 6 weeks

  • +8 more secondary outcomes

Other Outcomes (1)

  • Food environment perceptions

    baseline and at the end of 6 week intervention

Study Arms (2)

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

Participants will undergo 6 weeks of supervised resistance training

Resistance training

Participants are given recommendations on physical activity guidelines

Conventional physical activity guidelines

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri

Columbia, Missouri, 65211, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jaapna Dhillon, PhD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 5, 2021

First Posted

May 28, 2021

Study Start

May 19, 2021

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

March 13, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Immediately following publication. No end date.
Access Criteria
Data will be deposited in online data repositories.

Locations