Diet Impact on Insulin Resistance

Overseen By Elaina Marinik, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Polytechnic Institute and State University

Must not be taking: Diabetes medications, Antibiotics

Disqualifiers: Diabetes, Heart disease, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how consuming ultra-processed foods (UPF) affects insulin resistance and overall glucose control in middle-aged adults. Participants will follow either a high UPF controlled diet (an ultra-processed food diet) or a no UPF controlled diet (a minimally processed food diet) for six weeks. The study will explore how these diets influence gut health and inflammation, which might affect blood sugar levels. Ideal participants are middle-aged, have stable weight and activity levels, and are willing to follow a strict diet plan for eight weeks. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research on diet and health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on stable doses of estrogen, testosterone, or antihypertensive medications for more than 6 months, you can continue taking them.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that consuming a lot of ultra-processed foods (UPF) can harm health. Studies have found that these foods increase the risk of type 2 diabetes and other health issues. For example, one study found that eating more UPF might raise the risk of diabetes by affecting gut health and causing inflammation. Another study showed that a diet high in UPF links to a greater chance of mental health issues and heart problems.

Although these foods are common in many diets, their impact on long-term health can be concerning. Consider these potential risks when deciding to join a trial involving a high UPF diet. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different diets impact insulin resistance, specifically through the lens of ultra-processed foods (UPFs). Unlike typical treatments for insulin resistance, which often involve medications like metformin or lifestyle interventions focused on general diet and exercise, this trial zeroes in on the percentage of UPFs in a diet. The unique aspect here is the focus on the quality of food rather than just calorie control or macronutrient balance. By comparing a diet with 81% UPFs to one with none, researchers aim to uncover the direct effects of food processing on insulin sensitivity, which could lead to more tailored dietary recommendations for managing insulin resistance.

What evidence suggests that this trial's diets could be effective for improving glucose homeostasis?

Research shows that eating more ultra-processed foods (UPFs) can raise the risk of type 2 diabetes (T2D). One study found that increasing UPF intake by just 10% linked to a 12% higher risk of developing T2D. Other studies have shown that people who eat a lot of UPFs are more likely to have health problems like heart disease and high blood pressure. Experts have noticed that people with T2D who consume more UPFs tend to have lower survival rates and a higher risk of heart issues. In this trial, participants will join one of two dietary groups: one group will follow a High UPF controlled diet, consuming 81% of total energy from UPF, while the other group will follow a No UPF controlled diet, consuming 0% of total energy from UPF. This study aims to further explore the impact of UPF consumption on insulin resistance and related health outcomes. ^{2 3 6 7 8}

Who Is on the Research Team?

Brenda M Davy, PhD, RD

Principal Investigator

Virginia Polytechnic Institute and State University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Your weight has not changed in the past 6 months.

Verbal and written informed consent

You do not engage in regular physical activity.

Exclusion Criteria

You follow a vegetarian or vegan diet.

Pregnant or plans to become pregnant

I have a history of heart, lung, blood, hormone, or cancer-related diseases.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume a diet containing either 81% or 0% total energy from ultra-processed foods for 6 weeks

6 weeks

Baseline and post-diet laboratory visits

Follow-up

Participants are monitored for changes in insulin sensitivity, glucose control, and other health markers after the diet intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• High UPF controlled diet
• No UPF controlled diet

Trial Overview 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.

How Is the Trial Designed?

Group I: HIgh UPF (Ultra-processed foods) Experimental Treatment 1 Intervention

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

Group II: No UPF Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Virginia Polytechnic Institute and State University

Lead Sponsor

Trials

162

Recruited

26,900+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

Published Research Related to This Trial

In a study of 7,630 participants from the NHANES database, a higher intake of unsaturated fatty acids (UFA) relative to total fats was linked to lower insulin resistance, as indicated by significant reductions in the triglyceride-glucose index and HOMA-IR scores.

Logistic regression analysis revealed that individuals with higher UFA/total fat ratios had a lower risk of developing insulin resistance, particularly among certain subgroups such as the elderly and females, suggesting that dietary adjustments could be beneficial for these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High dietary intake of unsaturated fatty acids is associated with improved insulin resistance - a cross-sectional study based on the NHANES database. Chen, X., Gu, J., Huang, Y.[2023]

In a study of 21 healthy individuals, acute overfeeding with a high-carbohydrate diet improved insulin signaling in skeletal muscle, suggesting a potential increase in insulin sensitivity at the cellular level.

Conversely, overfeeding with a high-fat diet led to changes in insulin signaling that are associated with reduced insulin sensitivity, indicating that the macronutrient composition of the diet plays a crucial role in metabolic responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early responses of insulin signaling to high-carbohydrate and high-fat overfeeding. Adochio, RL., Leitner, JW., Gray, K., et al.[2021]

Insulin resistance (IR) is a key predictor of type 2 diabetes, primarily driven by excess body fat from high energy intake, but dietary content can also significantly influence IR independent of weight changes.

Modifying macronutrient composition in the diet, such as through the Mediterranean diet or adjusting fat and carbohydrate types, can modestly improve insulin sensitivity by 10-30%, which may have important implications for public health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What dietary modification best improves insulin sensitivity and why? Weickert, MO.[2017]

In a study of 13,528 nondiabetic adults, higher carbohydrate intake, glycemic index, and adherence to certain diet patterns (like sweets/fat and southern diets) were linked to increased fasting insulin levels, indicating higher insulin resistance.

Conversely, following plant-based and alcohol/salad diet patterns was associated with lower fasting insulin levels, suggesting that these diets may help reduce the risk of chronic diseases related to insulin resistance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet pattern may affect fasting insulin in a large sample of black and white adults. Gower, BA., Pearson, K., Bush, N., et al.[2022]

Recent research, including 30 studies, indicates that high consumption of ultra-processed foods (UPF) is linked to negative effects on metabolic health, such as increased risk of metabolic syndrome, obesity, and cardiovascular diseases.

The evidence suggests a strong need to reduce UPF consumption globally, especially among adults, although further studies are required to establish clear causal relationships and understand the underlying mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of ultra-processed food consumption on metabolic health. Costa de Miranda, R., Rauber, F., Levy, RB.[2021]

High consumption of ultra-processed foods (UPF) is linked to a significant increase in the risk of overweight/obesity (39%), high waist circumference (39%), and metabolic syndrome (79%) based on a systematic review of 23 studies.

In a large cohort of 183,491 participants followed for 3.5 to 19 years, high UPF consumption was associated with a 25% increased risk of all-cause mortality and a 29% increased risk of cardiovascular disease, indicating serious long-term health risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumption of ultra-processed foods and health status: a systematic review and meta-analysis. Pagliai, G., Dinu, M., Madarena, MP., et al.[2023]

In a study of 2,354 Iranian adults, those consuming the highest amounts of ultra-processed foods (UPFs) were found to be more than twice as likely to develop premature coronary artery disease (PCAD) compared to those with the lowest consumption levels.

The risk of severe PCAD also increased significantly with higher UPF consumption, indicating a strong association between UPF intake and both the likelihood and severity of coronary artery disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relationship between ultra processed food consumption and premature coronary artery disease: Iran premature coronary artery disease study (IPAD). Ansari, S., Mohammadifard, N., Haghighatdoost, F., et al.[2023]

In a study involving 1822 adults with overweight and prediabetes over 3 years, increases in both reported and estimated protein intake were linked to decreases in glycated hemoglobin (HbA1c), indicating potential benefits for blood sugar control.

While higher protein intake and lower energy intake were associated with reduced body mass index (BMI), they did not independently lead to improvements in insulin resistance (measured by HOMA-IR), suggesting that weight loss may be a key factor in managing insulin sensitivity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations of changes in reported and estimated protein and energy intake with changes in insulin resistance, glycated hemoglobin, and BMI during the PREVIEW lifestyle intervention study. Drummen, M., Adam, TC., Macdonald, IA., et al.[2023]

Excess body fat is the primary factor contributing to insulin resistance, but having a higher proportion of lean body mass can help mitigate this effect, and weight loss generally improves insulin sensitivity.

Diets high in saturated fats and low in dietary fiber are linked to reduced insulin sensitivity, while replacing saturated fats with monounsaturated fats and increasing fiber intake may promote better insulin sensitivity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thematic review series: patient-oriented research. Nutritional determinants of insulin resistance. McAuley, K., Mann, J.[2022]

A review of 43 studies found that 37 studies linked ultra-processed food (UPF) consumption to various adverse health outcomes, including obesity, type-2 diabetes, and cardiovascular diseases in adults, and cardio-metabolic risks in children.

No studies reported any beneficial health outcomes associated with UPF consumption, highlighting the need for dietary guidelines that consider the health risks of these foods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultra-Processed Foods and Health Outcomes: A Narrative Review. Elizabeth, L., Machado, P., Zinöcker, M., et al.[2021]

A high carbohydrate diet, when compared to a diet high in total and saturated fats, significantly improves insulin sensitivity and lipid levels.

Subjects following an ad-lib low fat, high carbohydrate diet not only lose weight but also experience greater improvements in metabolic issues related to insulin resistance syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The central role of dietary fat, not carbohydrate, in the insulin resistance syndrome. Purnell, JQ., Brunzell, JD.[2019]

Dietary fat subtypes play a crucial role in insulin action, with saturated fats linked to obesity and insulin resistance, while polyunsaturated fats (PUFAs) are associated with improved insulin sensitivity and reduced fat accumulation, as shown in animal models.

Emerging research indicates that not only fats but also protein sources can influence insulin resistance, with certain proteins like cod showing protective effects against insulin resistance compared to others like casein or soy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet composition and insulin action in animal models. Storlien, LH., Higgins, JA., Thomas, TC., et al.[2019]

High consumption of ultra-processed foods (UPFs), making up more than 10% of the diet, is associated with an increased risk of developing type 2 diabetes in adults, highlighting the need for better dietary habits.

UPFs are linked to various health concerns due to their high levels of sugars, sodium, and trans fats, as well as additives that may pose health risks, indicating a need for improved dietary guidelines and further research on their effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship between Ultra-Processed Food Consumption and Risk of Diabetes Mellitus: A Mini-Review. Almarshad, MI., Algonaiman, R., Alharbi, HF., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11852733/

Ultra-Processed Foods and Type 2 Diabetes Mellitus Their findings showed that a 10% increase in UPF consumption was associated with a 12% higher risk of T2DM. Interestingly, while higher UPF consumption was ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2949688825000103

The impact of ultra-processed foods on cardiovascular ... Individuals consuming the highest quantities of UPFs exhibit increased risks for cardiovascular and cerebrovascular events, type 2 diabetes, hypertension, ...

3. bmj.com bmj.com/content/384/bmj-2023-077310

Ultra-processed food exposure and adverse health outcomes Greater exposure to ultra-processed food was associated with a higher risk of adverse health outcomes, especially cardiometabolic, common mental disorder, and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11233771/

Ultra-processed foods consumption and health-related ... Prospective observational studies have reported significant associations between higher intake of UPFs and adverse health outcomes.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0002916523660253

Ultraprocessed food consumption is associated with all ... In participants with type 2 diabetes at study entry, higher UPF consumption was associated with reduced survival and higher CVD mortality rate, independent of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9228591/

Relationship between Ultra-Processed Food Consumption ... The high consumption of UPF, almost more than 10% of the diet proportion, could increase the risk of developing type 2 diabetes in adult individuals.

7. diabetesjournals.org diabetesjournals.org/care/article/46/7/1335/148548/Ultra-Processed-Food-Consumption-and-Risk-of-Type

Ultra-Processed Food Consumption and Risk of Type 2 ... UPFs and their components have been shown to negatively affect gut microbiota, systemic inflammation, insulin resistance, and body weight, ...

8. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2757497

Ultraprocessed Food Consumption and Risk of Type 2 ... Higher consumption of UPF was associated with higher FSAm-NPS DI scores (reflecting a poorer nutritional quality of the diet), higher intakes ...