The Influence of Physical Activity on the Gut Microbiome of Pre-Diabetic Adults
- Conditions
- Overweight and ObesityObesityOverweightType 2 Diabetes MellitusType 2 Diabetes Mellitus in ObeseType 2 DiabetesPreDiabetes
- Interventions
- Behavioral: Physical Activity Intervention
- Registration Number
- NCT04931836
- Lead Sponsor
- University of Minnesota
- Brief Summary
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.
- Detailed Description
All eligible and consented participants will complete a 3-week run-in phase during which baseline outcome assessments will be performed. During run-in weeks 1 and 2, participants will wear a Fitbit Inspire 2 smartwatch and complete three unannounced dietary recalls. During the run-in week 3 (see table below), participants will consume their 3-day standardized meal plan on days three through five, obtain a fecal sample, complete a study questionnaire, and complete a study assessment visit. To quantify compliance with the 3-day meal plan, participants will be provided with a paper checklist of all foods to be consumed, and will be asked to indicate which foods were consumed and to document any deviation. The study assessment visit will include a fasting blood draw (at baseline and week eight only), blood pressure in triplicate, weight measure and body fat assessment in duplicate, and a saliva sample.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 132
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Classified as overweight or obese with BMI 25.0-39.9 kg/m2.
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Documentation* of a prediabetes diagnosis within one year of enrollment by physician or primary care provider based on lab tests showing a fasted blood glucose of 100-125 mg/dL, a 2-hour oral glucose tolerance test of 140-199 mg/dL, or an HbA1c level of 5.7%-6.4%76; OR a study screening lab value of HbA1C within the afore mentioned range.
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Currently engaged in <100 min/week of physical activity - confirmed by questionnaire.
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No exercise contraindications as assessed by the Physical Activity Readiness Questionnaire (PAR-Q)78-this Questionnaire involves seven "yes" or "no" questions regarding an individual's health status, with answering "yes" to any one of these questions requiring a prospective participant to acquire a written doctor's note stating they can safely participate in the trial's exercise intervention.
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No self-reported physical/mental disabilities or gastrointestinal conditions.
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No antibiotic usage within the last 45 days.
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Stable weight over the last 6 months (<10% change).
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Not currently pregnant, planning to become pregnant, or currently breastfeeding.
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Willing to maintain current dietary and exercise habits, aside from any changes to be made per the study exercise protocol.
- Note: Documentation can include either a print out or screen shot of the lab value illustrating eligibility, along with the date of the test and the participant's name. If a hard copy is provided, the date and name will be redacted.
- Self-reported use of metformin and/or other medications that could interfere with the primary outcome.
- History of bariatric surgery or a history of other medical interventions that would interfere with the primary outcome.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Group Physical Activity Intervention Participants in this group will complete the physical activity intervention.
- Primary Outcome Measures
Name Time Method Chain in Serum Short Chain Fatty Acids (SCFA) 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 serum concentrations of acetate, propionate, and butyrate individually and sum of all SCFAs in units of ng/ml.
Change in Shannon Index 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.
- Secondary Outcome Measures
Name Time Method Hemoglobin A1C (HbA1c) 8 weeks Hemoglobin A1C (HbA1c) will be measured by laboratory test. This is a unitless measure.
Triglycerides 8 weeks Blood triglycerides will be measured using a standard laboratory test and reported in units of mg/dl.
Resting Blood Pressure (BP) 8 weeks Resting systolic and diastolic blood pressures will be reported in units of mmHg.
Body Composition 8 weeks Body composition will be analyzed using bioelectrical impedance. Outcome will be reported as percent body fat.
Fasting Insulin 8 weeks Fasting insulin will be measured by laboratory test and reported in units of uIU/ml.
Fasting Glucose 8 weeks Fasting insulin will be measured by standard laboratory test and reported in units of mg/dl.
High-density lipoprotein cholesterol (HDL-C) 8 weeks High-density lipoprotein cholesterol (HDL-C) will be measured using standard laboratory test and report in units of mg/dl.
C-reactive Protein (CRP) 8 weeks C-reactive protein (CRP) will be measured by laboratory test and reported in units of mg/l.
Trial Locations
- Locations (1)
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States