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Diet Impact on Insulin Resistance

N/A

Recruiting

Led By Brenda Davy, PhD RDN

Research Sponsored by Virginia Polytechnic Institute and State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 45-minute measurement in the laboratory, 2 timepoints (baseline, 6 weeks post high or no upf diet)

Awards & highlights

Study Summary

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

Who is the study for?

This trial is for middle-aged adults (45-65 years old) who are sedentary to moderately active, not planning to change their weight or activity level, and can commit to an 8-week study with daily food pickups. They must be stable in terms of medication for hormones and blood pressure if applicable, and not have a history of significant health issues like heart disease or diabetes.Check my eligibility

What is being tested?

The study tests the effects of ultra-processed foods on gut bacteria and blood sugar control. Participants will follow either a high UPF diet or a no UPF diet for eight weeks. Researchers aim to see how these diets affect glucose levels, gut microbiota changes, inflammation, and risk factors for type 2 diabetes.See study design

What are the potential side effects?

Since this trial involves dietary changes rather than medication, side effects may include digestive discomfort due to alterations in usual eating habits. Changes in gut microbiota could potentially lead to temporary gastrointestinal symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 45-minute measurement in the laboratory, 2 timepoints (baseline, 6 weeks post high or no upf diet)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~45-minute measurement in the laboratory, 2 timepoints (baseline, 6 weeks post high or no upf diet)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 45-minute measurement in the laboratory, 2 timepoints (baseline, 6 weeks post high or no upf diet) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in insulin sensitivity from baseline to 6-weeks post high or no UPF diet

Secondary outcome measures

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

+8 more

Other outcome measures

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

Change in brachial artery function from baseline to 6-weeks post high or no UPF diet

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: HIgh UPF (Ultra-processed foods)Experimental Treatment1 Intervention

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

Group II: No UPFActive Control1 Intervention

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Virginia Polytechnic Institute and State UniversityLead Sponsor

142 Previous Clinical Trials

27,715 Total Patients Enrolled

2 Trials studying Insulin Sensitivity

102 Patients Enrolled for Insulin Sensitivity

Duke UniversityOTHER

2,363 Previous Clinical Trials

3,420,464 Total Patients Enrolled

2 Trials studying Insulin Sensitivity

320 Patients Enrolled for Insulin Sensitivity

Brenda Davy, PhD RDNPrincipal InvestigatorVirginia Polytechnic Institute and State University

1 Previous Clinical Trials

375 Total Patients Enrolled

Media Library

High UPF controlled diet Clinical Trial Eligibility Overview. Trial Name: NCT05358171 — N/A

Insulin Sensitivity Research Study Groups: HIgh UPF (Ultra-processed foods), No UPF

Insulin Sensitivity Clinical Trial 2023: High UPF controlled diet Highlights & Side Effects. Trial Name: NCT05358171 — N/A

High UPF controlled diet 2023 Treatment Timeline for Medical Study. Trial Name: NCT05358171 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment amenable to participation from individuals aged 40 or above?

"This medical study is only open to individuals from 45-65 years old. For those who fall outside that age range, there are 26 trials available for minors and 91 trials dedicated to seniors."

Answered by AI

Does this experiment currently include any participants?

"According to the details on clinicaltrials.gov, this study is no longer looking for patient enrolment. The trial was initially posted October 1st 2022 and last edited a few weeks later; however, there are currently 163 other trials actively recruiting participants."

Answered by AI

Am I eligible to enroll in this experiment?

"This research endeavour will accept 42 adult patients aged 45-65 with insulin resistance. In addition to these prerequisites, the participants must have had a steady weight in their most recent 6 months, be capable of comprehending and signing informed consent documents, agree not to alter their physical activity levels or diet during the 8 week period, get food daily from designated locations and consume what is provided. Furthermore, they should intake approximately 60% total energy as per US average dietary standards (+/-15%) and if using hormone therapy it needs to remain consistent for over 6 months. Finally approval by Medical Director is necessary before enrolment into this clinical trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Brenda Davy 2023. "Ultra-processed Food Consumption, Gut Microbiota, and Glucose Homeostasis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05358171.