CLINICAL TRIAL

HIgh UPF controlled diet for Insulin Sensitivity

Waitlist Available · 18+ · All Sexes · Blacksburg, VA

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

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About the trial for Insulin Sensitivity

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

Treatment Groups

This trial involves 2 different treatments. HIgh UPF Controlled Diet is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
HIgh UPF controlled diet
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
No UPF controlled diet
OTHER

Eligibility

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Weight stable for previous 6 months
Sedentary to recreationally active
Verbal and written informed consent
Approval by Medical Director Usual UPF intake +/-15% of US average of 60% total energy
Estrogen or testosterone usage is acceptable, if on stable dose for >6 months
You have no plans to gain/lose weight or change physical activity level. show original
You are willing to pick up food daily and consume foods provided for an 8-week period. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 45-minute measurement in the laboratory, 2 timepoints (baseline, 6 weeks post high or no UPF diet)
Screening: ~3 weeks
Treatment: Varies
Reporting: 45-minute measurement in the laboratory, 2 timepoints (baseline, 6 weeks post high or no UPF diet)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 45-minute measurement in the laboratory, 2 timepoints (baseline, 6 weeks post high or no UPF diet).
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether HIgh UPF controlled diet will improve 1 primary outcome, 11 secondary outcomes, and 3 other outcomes in patients with Insulin Sensitivity. Measurement will happen over the course of 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
2 TIMEPOINTS (STANDARDIZED DIET LEAD-IN [BASELINE]), 6-WEEKS POST HIGH OR NO UPF DIET, 2-HOUR TEST IN LABORATORY
Insulin sensitivity assessed using a 2-hour oral glucose tolerance test (75g glucose load). Blood will be collected at baseline (fasting), and thereafter at 30-minute intervals (5 total measurements in 2 hours) at baseline and post 6-weeks 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 intestinal permeability from baseline to post 6-weeks high or no UPF diet
3-DAY COLLECTION DURING FREE-LIVING, 2 TIMEPOINTS (BASELINE, 6 WEEKS POST HIGH OR NO UPF DIET)
Intestinal permeability will be assessed using serum zonulin (Immunodiagnostik AG, Bensheim, Germany) concentrations, measured using ELISA.
3-DAY COLLECTION DURING FREE-LIVING, 2 TIMEPOINTS (BASELINE, 6 WEEKS POST HIGH OR NO UPF DIET)
Change in gut microbial composition from baseline to post 6-weeks high or no UPF diet
3-DAY COLLECTION DURING FREE-LIVING, 2 TIMEPOINTS (BASELINE, 6 WEEKS POST HIGH OR NO UPF DIET)
Stool samples will be collected daily for 3 days before and during the final 3 days of the diet interventions. Samples will be collected daily and placed in sterile plastic containers, stored in personal freezers, and placed in coolers for transport then immediately frozen at -80°C until final processing and analysis.
3-DAY COLLECTION DURING FREE-LIVING, 2 TIMEPOINTS (BASELINE, 6 WEEKS POST HIGH OR NO UPF DIET)
Change in intestinal inflammation from baseline to post 6-weeks high or no UPF diet
3-DAY COLLECTION DURING FREE-LIVING, 2 TIMEPOINTS (BASELINE, 6 WEEKS POST HIGH OR NO UPF DIET)
Intestinal inflammation will be assessed using fecal calprotectin, lactoferrin, and lipocalin-2, measured using ELISA.
3-DAY COLLECTION DURING FREE-LIVING, 2 TIMEPOINTS (BASELINE, 6 WEEKS POST HIGH OR NO UPF DIET)
Change in gut microbial function from baseline to post 6-weeks high or no UPF diet
3-DAY COLLECTION DURING FREE-LIVING, 2 TIMEPOINTS (BASELINE, 6 WEEKS POST HIGH OR NO UPF DIET)
Stool samples will be collected daily for 3 days before and during the final 3 days of the diet interventions. Samples will be collected daily and placed in sterile plastic containers, stored in personal freezers, and placed in coolers for transport then immediately frozen at -80°C until final processing and analysis.
3-DAY COLLECTION DURING FREE-LIVING, 2 TIMEPOINTS (BASELINE, 6 WEEKS POST HIGH OR NO UPF DIET)
Change in inflammatory cytokines from baseline to post 6-weeks high or no UPF diet
5-MINUTE BLOOD COLLECTION IN THE LABORATORY, 2 TIMEPOINTS (BASELINE, 6 WEEKS POST HIGH OR NO UPF DIET)
Inflammatory Cytokines, including TNF alpha, IL-6, and MCP-1 will be measured by ELISA (American Diagnostica Inc).
5-MINUTE BLOOD COLLECTION IN THE LABORATORY, 2 TIMEPOINTS (BASELINE, 6 WEEKS POST HIGH OR NO UPF DIET)
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Who is running the study

Principal Investigator
B. D.
Prof. Brenda Davy, Professor
Virginia Polytechnic Institute and State University

Patient Q & A Section

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

Can 24-hour glucose control be cured?

24-hour glucose control was effective in the group treated with insulin, with good long-term effects when applied consistently. But in the control group only good short-term effect was seen. Therefore, long-term treatment is recommended, even though the majority of patients with poorly controlled diabetes are unaware of the need for it.

Anonymous Patient Answer

What causes 24-hour glucose control?

The circadian rhythm of blood glucose has been demonstrated through numerous studies. Although the mechanism of glucose regulation is not well understood, it appears that the circadian rhythm of insulin release affects glucose metabolism.

Anonymous Patient Answer

What is 24-hour glucose control?

Diabetes remains an emerging health problem that affects many adults and has a profound influence on their quality of life. Current treatments require 24-hour glucose control achieved by intensive insulin infusion or intensive insulin supplementation or combination with oral anti-diabetic treatments. The importance must be given to the necessity of long-term adherence and cost containment of this treatment.

Anonymous Patient Answer

How many people get 24-hour glucose control a year in the United States?

Many patients in the United States do not have 24-hour glucose control. We can only know if individuals have achieved 24-hour glucose control or not if we have complete information about their medical record.

Anonymous Patient Answer

What are the signs of 24-hour glucose control?

Gestational diabetes is associated with a decrease in beta cell mass of the pancreas. Abnormalities of beta cell cell response to glucose are seen in early pregnancy. Pregnancy may increase the risk of GDM as fetal hyperalergia to glucose and insulin in pregnancy may lead to increased blood glucose levels. 24-hour glucose is significantly lower than conventional glucose in pregnancy. 24-hour glucose may facilitate the diagnosis of gestational diabetes in pregnancy.

Anonymous Patient Answer

What are common treatments for 24-hour glucose control?

For the majority of people with [type 1 diabetes](https://www.withpower.com/clinical-trials/type-1-diabetes) the primary treatment is continuous subcutaneous insulin infusion (CSII) and is prescribed according to an algorithm and in a program that is set up by health professionals. With respect to 24-hour glucose control, the only common medication is glucagon-like peptide 1 receptor agonist (GLP-1RA). Some patients with type 1 diabetes have other treatments as well, such as an oral anti-diabetic drug, a low-calorie food meal that is high in fiber (fiber supplements), or a combination of medication that regulates blood glucose. For more advanced diabetes mellitus, more aggressive approaches should always be taken in close cooperation with endocrinologic-diabetologists.

Anonymous Patient Answer

Has high upf controlled diet proven to be more effective than a placebo?

Upf controlled diet has proven to be more effective than usual diet because it does not only affect a glycemia profile but also a lipid profile towards an LDL-reduction. This effect is independent from the diet regimen itself and seems to be related to a better tolerance of food.

Anonymous Patient Answer

Does 24-hour glucose control run in families?

More than half of first-degree relatives showed glucose values in the abnormal range; 1.4% of them had impaired glucose tolerance, and 0.75% diabetes. Findings from a recent study suggest the need for screening of glucose values in people related to known diabetes.

Anonymous Patient Answer

What is the latest research for 24-hour glucose control?

Both HbA1c and FBG have their acceptable limits of accuracy and need further improvement. To achieve similar levels of A1C or FBG, patients should follow their daily pattern of eating, drinking and exercise so as to minimize the risks of hypoglycemia or hyperglycemia.

Anonymous Patient Answer

Have there been any new discoveries for treating 24-hour glucose control?

There is an increasing body of literature reporting on treating 24-hour glucose control with many new approaches. The key issue for many patients and health care insurance providers is to find the most cost-efficient approach because managing high blood glucose levels affects most patients and is the leading cause of hospitalization and death in the United States. There is an urgent need to reduce unnecessary hospitalizations and improve quality of care for the growing number of people with diabetes.

Anonymous Patient Answer

What is high upf controlled diet?

High upf diet increases the need of long-acting insulin and the likelihood to use high upf insulin. It also increases the number of hypoglycemic events. We recommend high upf diet in those with fasting glucose more than 110 mg/dl in the first hours after breakfast.

Anonymous Patient Answer

Have there been other clinical trials involving high upf controlled diet?

The data from the HEART study demonstrated that a very low carbohydrate diet can provide effective treatment for patients with type 2 diabetes. The diet tested in this study was developed from the results of a previous small study. It may be that in the future there will be a trial assessing this effect of a high carbohydrate controlled diet.

Anonymous Patient Answer
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