Clinical trial NCT04906525: Resistance Training Effects on Gut Microbiome and Cardiometabolic Outcomes
Official title: Effects of 6-week Resistance Training Intervention on Gut Microbiome and Cardiometabolic Outcomes in Adults With Overweight and Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise Intervention
Keywords: Gut Microbiome
Resistance Training
Physical Activity
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2021-05-28
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in stool microbiome diversity
timeFrame: Change over 6 weeks
measure: Change in stool microbiome composition
timeFrame: Change over 6 weeks
Secondary outcomes:
measure: Change in blood pressure
timeFrame: change over 6 weeks
measure: Fat mass
timeFrame: Change over 6 weeks
measure: Fat free mass
timeFrame: Change over 6 weeks
measure: Change in fasting glucose
timeFrame: change over 6 weeks
measure: Change in glucose regulation
timeFrame: change over 6 weeks
measure: Hip circumference
timeFrame: change over 6 weeks
measure: Waist circumference
timeFrame: change over 6 weeks
measure: Physical activity
timeFrame: change over 6 weeks
measure: Sleep Quality
timeFrame: change over 6 weeks
measure: Sleep Duration
timeFrame: change over 6 weeks
measure: 24hr appetite ratings
timeFrame: Once at baseline and at the end of 6 week intervention
measure: Change in Body mass
timeFrame: change over 6 weeks
measure: Short chain fatty acids
timeFrame: Change over 6 weeks
Other outcomes:
measure: Food environment perceptions
timeFrame: baseline and at the end of 6 week intervention
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Jaapna Dhillon, PhD
role: PRINCIPAL_INVESTIGATOR
References: