Ultra-processed Food Consumption, Gut Microbiota, and Glucose Homeostasis (NCT05358171) | Clinical Trial Compass
CompletedNot Applicable
Ultra-processed Food Consumption, Gut Microbiota, and Glucose Homeostasis
United States20 participantsStarted 2023-03-15
Plain-language 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-aged/older adults, and declines in glucose tolerance are evident in the third or fourth decade of life. Thus, there is an urgent need to identify new approaches for the prevention of type 2 diabetes among middle-aged adults. Observational research has linked intake of ultra-processed foods (UPF), which comprise \~60% of total energy intake in US adults, with increased risk of T2D. Ex vivo and animal research suggests that components of UPF alter gut microbiota composition and initiate a cascade of events leading to intestinal inflammation and impaired glycemic control. Whether mid-life adults (aged 45-65 yrs) are susceptible to the adverse impact of UPF consumption on glucose homeostasis is unknown. The overall objective of this study is to establish proof-of-concept for an impairment in glucose homeostasis following increases in UPF consumption in mid-life adults, in order to conduct a larger, more comprehensive and mechanistic trial in the future. In addition, changes in gut microbial composition and function, intestinal inflammation and permeability, serum endotoxin concentrations, and inflammatory cytokines as potential mechanisms by which UPF consumption influences glucose homeostasis will be investigated.
Who can participate
Age range
40 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in insulin sensitivity from baseline to 6-weeks post high or no UPF diet
Timeframe: 2 timepoints (standardized diet lead-in [baseline]), 6-weeks post high or no UPF diet, 2-hour test in laboratory
Trial details
NCT IDNCT05358171
SponsorVirginia Polytechnic Institute and State University