HIgh UPF controlled diet for Insulin Resistance

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Insulin Resistance+2 More
HIgh UPF controlled diet - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will establish whether mid-life adults are susceptible to the adverse impact of consuming ultra-processed foods on glucose homeostasis.

Eligible Conditions
  • Insulin Resistance
  • Insulin Sensitivity
  • 24-hour Glucose Control

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Insulin Resistance

Study Objectives

1 Primary · 11 Secondary · Reporting Duration: 45-minute measurement in the laboratory, 2 timepoints (baseline, 6 weeks post high or no UPF diet)

2 timepoints (standardized diet lead-in [baseline]), 6-weeks post high or no UPF diet, 2-hour test in laboratory
Change in insulin sensitivity from baseline to 6-weeks post high or no UPF diet
Week 6
Change in gut microbial composition from baseline to post 6-weeks high or no UPF diet
Change in gut microbial function from baseline to post 6-weeks high or no UPF diet
Change in intestinal inflammation from baseline to post 6-weeks high or no UPF diet
Change in intestinal permeability from baseline to post 6-weeks high or no UPF diet
Week 6
Change in brachial artery function from baseline to 6-weeks post high or no UPF diet
Week 6
Change in arterial stiffness (Beta-stiffness index) from baseline to 6-weeks post high or no UPF diet
Change in arterial stiffness (Carotid femoral pulse wave velocity) from baseline to 6-weeks post high or no UPF diet
Week 6
Change in endotoxin from baseline to post 6-weeks high or no UPF diet
Change in inflammatory cytokines from baseline to post 6-weeks high or no UPF diet
Week 6
Change in 24-hour glucose control (24-hour mean) from baseline to 6-weeks post high or no UPF diet
Change in 24-hour glucose control (AUC) from baseline to 6-weeks post high or no UPF diet
Change in 24-hour glucose control (glycemic variability [GV]) from baseline to 6-weeks post high or no UPF diet
Change in 24-hour glucose control (postprandial glucose) from baseline to 6-weeks post high or no UPF diet
Change in 24-hour glucose control (time in range) from baseline to 6-weeks post high or no UPF diet

Trial Safety

Safety Progress

1 of 3

Other trials for Insulin Resistance

Trial Design

2 Treatment Groups

No UPF
1 of 2
HIgh UPF (Ultra-processed foods)
1 of 2
Active Control
Experimental Treatment

42 Total Participants · 2 Treatment Groups

Primary Treatment: HIgh UPF controlled diet · No Placebo Group · N/A

HIgh UPF (Ultra-processed foods)
Other
Experimental Group · 1 Intervention: HIgh UPF controlled diet · Intervention Types: Other
No UPF
Other
ActiveComparator Group · 1 Intervention: No UPF controlled diet · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 45-minute measurement in the laboratory, 2 timepoints (baseline, 6 weeks post high or no upf diet)

Who is running the clinical trial?

Duke UniversityOTHER
2,154 Previous Clinical Trials
3,179,666 Total Patients Enrolled
8 Trials studying Insulin Resistance
1,071 Patients Enrolled for Insulin Resistance
Virginia Polytechnic Institute and State UniversityLead Sponsor
110 Previous Clinical Trials
25,729 Total Patients Enrolled
2 Trials studying Insulin Resistance
102 Patients Enrolled for Insulin Resistance
Brenda Davy, PhD RDNPrincipal InvestigatorVirginia Polytechnic Institute and State University

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have no plans to gain/lose weight or change physical activity level.
You are willing to pick up food daily and consume foods provided for an 8-week period.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 13th, 2021

Last Reviewed: October 7th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.