Status:
COMPLETED
Ultra-processed Food Consumption, Gut Microbiota, and Glucose Homeostasis
Lead Sponsor:
Virginia Polytechnic Institute and State University
Collaborating Sponsors:
Duke University
Conditions:
Insulin Sensitivity
24-hour Glucose Control
Eligibility:
All Genders
40-65 years
Phase:
NA
Brief Summary
Advancing age is associated with gut dysbiosis, low-grade chronic inflammation, progressive insulin resistance, and increased risk of type 2 diabetes (T2D). Prediabetes is present in 45-50% of middle-...
Eligibility Criteria
Inclusion
- Weight stable for previous 6 months
- Sedentary to recreationally active
- No plans to gain/lose weight or change physical activity level
- Willing to pick up food daily and consume foods provided for an 8-week period
- Verbal and written informed consent
- Approval by Medical Director
- Estrogen or testosterone usage is acceptable, if on stable dose for \>6 months
Exclusion
- BMI \>35 kg/m2
- Diabetes or diabetes medication
- Antibiotic, prebiotic or prebiotic use in prior 3 months
- TCHOL \>6.2 mmol/L; TG \>4.5 mmol/L
- Blood pressure (BP) \> 159/99 mmHg (Stable BP on antihypertensive medications used for \>6 months is acceptable)
- Diagnosed inflammatory bowel disease
- Past or current heart diseases, stroke, respiratory disease, endocrine or metabolic disease, or hematological-oncological disease
- Vegetarian or vegan
- Pregnant or plans to become pregnant
- Food allergies or aversions
- 3 or fewer stools per week or regular laxative use
Key Trial Info
Start Date :
March 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05358171
Start Date
March 15 2023
End Date
September 30 2025
Last Update
December 18 2025
Active Locations (1)
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1
Virginia Tech
Blacksburg, Virginia, United States, 24061