Ultra-processed Food Consumption, Gut Microbiota, and Glucose Homeostasis

Virginia Polytechnic Institute and State University

Status: Completed

Conditions: 24-hour Glucose Control; Insulin Sensitivity

Treatments: Other: No UPF controlled diet; Other: HIgh UPF controlled diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05358171

21-974

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

HIgh UPF (Ultra-processed foods)

Experimental group

Description:

Participants will consume a diet containing 81% total energy from UPF for 6 weeks

Treatment:

Other: HIgh UPF controlled diet

No UPF

Active Comparator group

Description:

Participants will consume a diet containing 0% total energy from UPF for 6 weeks

Treatment:

Other: No UPF controlled diet