Adults 30 to 64, any sex, with Obesity or Overweight. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Shannon Index (Unitless)Primary· 8 weeks
Changes to the gut microbiome will be assessed via metagenomic sequencing, from pre- to post-intervention. The Shannon Index-a measure of microbial community diversity-will be the primary indicator for changes in gut microbiota composition, and will be assessed at baseline, and following the 4th and 8th weeks. Index values are unitless and range from 0 to 1. Lower values indicate more diversity while higher values indicate less diversity. Outcome will be reported at baseline, 4 weeks, and 8 weeks and as the change from baseline to 4 weeks and baseline to 8 weeks.
Group
Value
95% CI
Intervention
-0.20
± .073
Control
0.013
± .072
Change in Serum Short Chain Fatty Acids (SCFA)Primary· 8 weeks
Participants will undergo fasted blood draws to assess serum SCFA levels. This work will be performed using the Metabolon pipeline. Outcome is reported as the sum of the serum concentrations of acetate, propionate, and butyrate in Z-score units. We report the Week 8 means and standard errors from a linear model adjusted for the Week 0 (baseline) values. The original units are reported in ng/mL and the final results are reported as standardized z-scores in which each value subtracts the mean and the difference is divided by the standard deviation. Higher values represent higher levels of SCFA w
High-density lipoprotein cholesterol (HDL-C) will be measured using standard laboratory test and report in units of mg/dl. We report the Week 8 means and standard errors from a linear model adjusted for the Week 0 (baseline) values.
Group
Value
95% CI
Intervention
53.4
± 0.73
Control
51.7
± 0.69
TriglyceridesSecondary· 8 weeks
Blood triglycerides will be measured using a standard laboratory test and reported in units of mg/dl. We report the Week 8 means and standard errors from a linear model adjusted for the Week 0 (baseline) values.
Group
Value
95% CI
Intervention
147.2
± 7.08
Control
142.7
± 6.70
Fasting InsulinSecondary· 8 weeks
Fasting insulin will be measured by laboratory test and reported in units of pm/ml. We report the Week 8 means and standard errors from a linear model adjusted for the Week 0 (baseline) values.
Group
Value
95% CI
Intervention
132.5
± 8.96
Control
134.8
± 8.44
Fasting GlucoseSecondary· 8 weeks
Fasting glucose will be measured by standard laboratory test and reported in units of mg/dl. We report the Week 8 means and standard errors from a linear model adjusted for the Week 0 (baseline) values.
Group
Value
95% CI
Intervention
105.0
± 1.42
Control
105.0
± 1.35
C-reactive Protein (CRP)Secondary· 8 weeks
C-reactive protein (CRP) will be measured by laboratory test and reported in units of mg/l. We report the Week 8 means and standard errors from a linear model adjusted for the Week 0 (baseline) values.
Resting systolic blood pressure will be reported in units of mmHg. We report the Week 8 means and standard errors from a linear model adjusted for the Week 0 (baseline) values.
Group
Value
95% CI
Intervention
121
± 1.9
Control
120
± 1.8
Body CompositionSecondary· 8 weeks
Body composition will be analyzed using bioelectrical impedance. Outcome will be reported as percent body fat. We report the Week 8 means and standard errors from a linear model adjusted for the Week 0 (baseline) values.
The Cardiometabolic Risk Score (CMR) is the mean Z-score across systolic blood pressure, glucose, insulin, HDL, % body fat, and triglycerides. We report the Week 8 means and standard errors from a linear model adjusted for the Week 0 (baseline) values. The final results are reported as standardized z-scores in which each value subtracts the mean and the difference is divided by the standard deviation. Higher values represent higher levels of cardiometabolic risk which is considered worse. The scale is in standard deviation units. A value of 0 = the population mean.
Group
Value
95% CI
Experimental Group
-.01
± .050
Control Group
-.04
± .047
Sponsor's own description
The present study is a 100-participant randomized controlled 2-arm parallel trial that employs a metagenomic approach to examine how 8 weeks of supervised moderate-intensity treadmill walking exercise (MWE) for 30-45 min 3 times/week alters the gut microbiome, serum short chain fatty acids, and the cardiometabolic profile, body weight, and body composition of individuals 30-64 years old who have overweight or obesity and have prediabetes.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by University of Minnesota
Last refreshed: 13 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04931836.