Trial Outcomes & Findings for The Influence of Physical Activity on the Gut Microbiome of Pre-Diabetic Adults (NCT NCT04931836)

Last Updated: 2025-06-13

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

77 participants

Primary outcome timeframe

8 weeks

Results posted on

2025-06-13

Participant Flow

Participants were recruited on a rolling basis through a combination of the following methods: clinical referrals via partners within community-based health clinics, and fliers posted on physical (e.g. campus buildings, community billboards) and virtual (e.g. Facebook, NextDoor) walls. Finally, eligible participants based on electronic health record were identified and and invitation was sent via 'My Chart' directly to the prospective participant.

After consenting, participants entered a three week run-in period during which time they provided a baseline stool sample, continued regular activity, used a study provided fitbit to monitor baseline physical activity levels, and responded to three phone dietary assessments.

Participant milestones

Participant milestones
Measure	Experimental Group Participants in this group will complete the physical activity intervention.	Control Group Participants in this group will be asked to maintain their normal level of physical activity.
Overall Study STARTED	39	38
Overall Study COMPLETED	35	37
Overall Study NOT COMPLETED	4	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Influence of Physical Activity on the Gut Microbiome of Pre-Diabetic Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=39 Participants Three walking sessions/week for a total of 8 weeks (24 total sessions) - Walking sessions occurred remotely at or around a participant's home. Regardless of the walking location, walking sessions were 30 min in duration during intervention weeks 1 through 4 and a minimum of 45 min each during intervention weeks 5 through 8.	Control n=38 Participants Participants in this group were asked to maintain their normal level of physical activity.	Total n=77 Participants Total of all reporting groups
Age, Continuous	49.9 Years STANDARD_DEVIATION 9.3 • n=93 Participants	53.1 Years STANDARD_DEVIATION 8.5 • n=4 Participants	51.4 Years STANDARD_DEVIATION 9.0 • n=27 Participants
Sex: Female, Male Female	34 Participants n=93 Participants	32 Participants n=4 Participants	66 Participants n=27 Participants
Sex: Female, Male Male	5 Participants n=93 Participants	6 Participants n=4 Participants	11 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants	3 Participants n=4 Participants	5 Participants n=27 Participants
Race (NIH/OMB) White	31 Participants n=93 Participants	27 Participants n=4 Participants	58 Participants n=27 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=93 Participants	6 Participants n=4 Participants	10 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=93 Participants	4 Participants n=4 Participants	6 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	34 Participants n=93 Participants	30 Participants n=4 Participants	64 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=93 Participants	4 Participants n=4 Participants	7 Participants n=27 Participants
Region of Enrollment United States	39 Participants n=93 Participants	38 Participants n=4 Participants	77 Participants n=27 Participants
Weight (kg)	99 Kilogram STANDARD_DEVIATION 21.5 • n=93 Participants	97.1 Kilogram STANDARD_DEVIATION 19.6 • n=4 Participants	98.1 Kilogram STANDARD_DEVIATION 20.5 • n=27 Participants
BMI	34.7 kg/m^2 STANDARD_DEVIATION 6.1 • n=93 Participants	34.1 kg/m^2 STANDARD_DEVIATION 5.4 • n=4 Participants	34.4 kg/m^2 STANDARD_DEVIATION 5.7 • n=27 Participants
Percent body fat	44.0 % STANDARD_DEVIATION 7.2 • n=93 Participants	43.5 % STANDARD_DEVIATION 6.7 • n=4 Participants	43.8 % STANDARD_DEVIATION 6.9 • n=27 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: There were 6 participants with missing microbiome data.

Outcome measures

Outcome measures
Measure	Intervention n=35 Participants Three walking sessions/week for a total of 8 weeks (24 total sessions) - Walking sessions occurred remotely at or around a participant's home. Regardless of the walking location, walking sessions were 30 min in duration during intervention weeks 1 through 4 and a minimum of 45 min each during intervention weeks 5 through 8.	Control n=36 Participants Participants in this group were asked to maintain their normal level of physical activity.
Change in Shannon Index (Unitless)	-0.20 units on a scale Standard Error .073	0.013 units on a scale Standard Error .072

PRIMARY outcome

Timeframe: 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 which is considered better. The scale is in standard deviation units. A value of 0 = the population mean.

Outcome measures

Outcome measures
Measure	Intervention n=33 Participants Three walking sessions/week for a total of 8 weeks (24 total sessions) - Walking sessions occurred remotely at or around a participant's home. Regardless of the walking location, walking sessions were 30 min in duration during intervention weeks 1 through 4 and a minimum of 45 min each during intervention weeks 5 through 8.	Control n=37 Participants Participants in this group were asked to maintain their normal level of physical activity.
Change in Serum Short Chain Fatty Acids (SCFA)	0.19 score on a scale Standard Error 0.107	0.08 score on a scale Standard Error 0.101

SECONDARY outcome

Timeframe: 8 weeks

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.

Outcome measures

Outcome measures
Measure	Intervention n=33 Participants Three walking sessions/week for a total of 8 weeks (24 total sessions) - Walking sessions occurred remotely at or around a participant's home. Regardless of the walking location, walking sessions were 30 min in duration during intervention weeks 1 through 4 and a minimum of 45 min each during intervention weeks 5 through 8.	Control n=37 Participants Participants in this group were asked to maintain their normal level of physical activity.
High-density Lipoprotein Cholesterol (HDL-C)	53.4 mg/dL Standard Error 0.73	51.7 mg/dL Standard Error 0.69

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention n=33 Participants Three walking sessions/week for a total of 8 weeks (24 total sessions) - Walking sessions occurred remotely at or around a participant's home. Regardless of the walking location, walking sessions were 30 min in duration during intervention weeks 1 through 4 and a minimum of 45 min each during intervention weeks 5 through 8.	Control n=37 Participants Participants in this group were asked to maintain their normal level of physical activity.
Triglycerides	147.2 mg/dL Standard Error 7.08	142.7 mg/dL Standard Error 6.70

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention n=32 Participants Three walking sessions/week for a total of 8 weeks (24 total sessions) - Walking sessions occurred remotely at or around a participant's home. Regardless of the walking location, walking sessions were 30 min in duration during intervention weeks 1 through 4 and a minimum of 45 min each during intervention weeks 5 through 8.	Control n=36 Participants Participants in this group were asked to maintain their normal level of physical activity.
Fasting Insulin	132.5 pm/L Standard Error 8.96	134.8 pm/L Standard Error 8.44

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention n=33 Participants Three walking sessions/week for a total of 8 weeks (24 total sessions) - Walking sessions occurred remotely at or around a participant's home. Regardless of the walking location, walking sessions were 30 min in duration during intervention weeks 1 through 4 and a minimum of 45 min each during intervention weeks 5 through 8.	Control n=36 Participants Participants in this group were asked to maintain their normal level of physical activity.
Fasting Glucose	105.0 mg/dL Standard Error 1.42	105.0 mg/dL Standard Error 1.35

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention n=31 Participants Three walking sessions/week for a total of 8 weeks (24 total sessions) - Walking sessions occurred remotely at or around a participant's home. Regardless of the walking location, walking sessions were 30 min in duration during intervention weeks 1 through 4 and a minimum of 45 min each during intervention weeks 5 through 8.	Control n=37 Participants Participants in this group were asked to maintain their normal level of physical activity.
C-reactive Protein (CRP)	4.6 mg/L Standard Error 0.36	4.5 mg/L Standard Error 0.33

SECONDARY outcome

Timeframe: 8 weeks

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.

Outcome measures

Outcome measures
Measure	Intervention n=34 Participants Three walking sessions/week for a total of 8 weeks (24 total sessions) - Walking sessions occurred remotely at or around a participant's home. Regardless of the walking location, walking sessions were 30 min in duration during intervention weeks 1 through 4 and a minimum of 45 min each during intervention weeks 5 through 8.	Control n=36 Participants Participants in this group were asked to maintain their normal level of physical activity.
Resting Systolic Blood Pressure (BP)	121 mmHg Standard Error 1.9	120 mmHg Standard Error 1.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention n=34 Participants Three walking sessions/week for a total of 8 weeks (24 total sessions) - Walking sessions occurred remotely at or around a participant's home. Regardless of the walking location, walking sessions were 30 min in duration during intervention weeks 1 through 4 and a minimum of 45 min each during intervention weeks 5 through 8.	Control n=36 Participants Participants in this group were asked to maintain their normal level of physical activity.
Body Composition	43.5 Percentage Standard Error 0.41	43.6 Percentage Standard Error 0.40

SECONDARY outcome

Timeframe: 8 weeks

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.

Outcome measures

Outcome measures
Measure	Intervention n=30 Participants Three walking sessions/week for a total of 8 weeks (24 total sessions) - Walking sessions occurred remotely at or around a participant's home. Regardless of the walking location, walking sessions were 30 min in duration during intervention weeks 1 through 4 and a minimum of 45 min each during intervention weeks 5 through 8.	Control n=35 Participants Participants in this group were asked to maintain their normal level of physical activity.
Cardiometabolic Risk Score (CMR)	-.01 z-score standardized units Standard Error .050	-.04 z-score standardized units Standard Error .047

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mark Pereira, PhD

University of Minnesota

Phone: 612-624-4173

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place