Clinical trial NCT05358171: Ultra-processed Food Consumption, Gut Microbiota, and Glucose Homeostasis
Official title: Ultra-processed Food Consumption, Gut Microbiota, and Glucose Homeostasis in Mid-life Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Insulin Sensitivity
24-hour Glucose Control
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
Collaborators: name: Duke University
First posted: 2022-05-03
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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-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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Change in 24-hour glucose control (24-hour mean) from baseline to 6-weeks post high or no UPF diet
timeFrame: 6-day measurement during free-living, 2 timepoints (baseline, 6 weeks post high or no UPF diet)
measure: Change in 24-hour glucose control (AUC) from baseline to 6-weeks post high or no UPF diet
timeFrame: 6-day measurement during free-living, 2 timepoints (baseline, 6 weeks post high or no UPF diet)
measure: Change in 24-hour glucose control (time in range) from baseline to 6-weeks post high or no UPF diet
timeFrame: 6-day measurement during free-living, 2 timepoints (baseline, 6 weeks post high or no UPF diet)
measure: Change in 24-hour glucose control (glycemic variability [GV]) from baseline to 6-weeks post high or no UPF diet
timeFrame: 6-day measurement during free-living, 2 timepoints (baseline, 6 weeks post high or no UPF diet)
measure: Change in 24-hour glucose control (postprandial glucose) from baseline to 6-weeks post high or no UPF diet
timeFrame: 6-day measurement during free-living, 2 timepoints (baseline, 6 weeks post high or no UPF diet)
measure: Change in inflammatory cytokines from baseline to post 6-weeks high or no UPF diet
timeFrame: 5-minute blood collection in the laboratory, 2 timepoints (baseline, 6 weeks post high or no UPF diet)
measure: Change in endotoxin from baseline to post 6-weeks high or no UPF diet
timeFrame: 5-minute blood collection in the laboratory, 2 timepoints (baseline, 6 weeks post high or no UPF diet)
measure: Change in gut microbial composition from baseline to post 6-weeks high or no UPF diet
timeFrame: 3-day collection during free-living, 2 timepoints (baseline, 6 weeks post high or no UPF diet)
measure: Change in gut microbial function from baseline to post 6-weeks high or no UPF diet
timeFrame: 3-day collection during free-living, 2 timepoints (baseline, 6 weeks post high or no UPF diet)
measure: Change in intestinal inflammation from baseline to post 6-weeks high or no UPF diet
timeFrame: 3-day collection during free-living, 2 timepoints (baseline, 6 weeks post high or no UPF diet)
measure: Change in intestinal permeability from baseline to post 6-weeks high or no UPF diet
timeFrame: 3-day collection during free-living, 2 timepoints (baseline, 6 weeks post high or no UPF diet)
Other outcomes:
measure: Change in brachial artery function from baseline to 6-weeks post high or no UPF diet
timeFrame: 30-minute measurement in the laboratory, 2 timepoints (baseline, 6 weeks post high or no UPF diet)
measure: Change in arterial stiffness (Carotid femoral pulse wave velocity) from baseline to 6-weeks post high or no UPF diet
timeFrame: 45-minute measurement in the laboratory, 2 timepoints (baseline, 6 weeks post high or no UPF diet)
measure: Change in arterial stiffness (Beta-stiffness index) from baseline to 6-weeks post high or no UPF diet
timeFrame: 45-minute measurement in the laboratory, 2 timepoints (baseline, 6 weeks post high or no UPF diet)
Locations:
city: Blacksburg
country: United States
facility: Virginia Tech
state: Virginia
Study officials:
affiliation: Virginia Polytechnic Institute and State University
name: Brenda Davy, PhD RDN
role: PRINCIPAL_INVESTIGATOR
References: