High-Fat Diet for Insulin Resistance

(MetFlexHFD Trial)

No longer recruiting at 1 trial location

Overseen By Nicholas A Foreman, MS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: George Washington University

Must not be taking: Antioxidants, NSAIDs, Antibiotics, others

Disqualifiers: Pregnancy, Eating disorders, Gastrointestinal diseases, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how a high-fat diet affects the body's response to blood sugar after eating. Participants will follow a hypercaloric, high-fat diet for three days to assess its impact on sugar processing compared to a regular diet. The study will also explore whether biological sex influences these effects. This trial suits adults aged 20-45 who are generally healthy and not on certain medications or diets. Participants should not have food allergies or a history of disordered eating. As an unphased study, this trial offers participants the chance to contribute to foundational research that could enhance dietary guidelines.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications, including antioxidant supplements, prescription anti-inflammatory drugs, antibiotics, steroids, probiotics, and medications for cholesterol, diabetes, or weight management.

What prior data suggests that this high-fat diet is safe for healthy adults?

Research has shown that high-fat diets are generally safe for short-term use in people. Studies have found that consuming a lot of fats doesn't cause immediate harm, though less is known about long-term effects. For example, one study found that while a high-fat diet can make it harder for the body to process sugar, it doesn't seem to have major health impacts in the short term. Another source suggests that these diets can lead to weight gain and make it harder for the body to use insulin, but they are not harmful when used briefly.

In this trial, participants will follow a high-fat diet for just three days, aligning with the short-term use studied in research. This approach is likely to be well-tolerated by participants without serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how a hypercaloric, high-fat diet can impact insulin resistance in a new way. Unlike standard treatments for insulin resistance, which often focus on medication or low-calorie diets to lower blood sugar and improve insulin sensitivity, this approach increases calorie and fat intake to see its effects on the body. By consuming 165% of daily energy needs with 65% of those calories from fat, the trial could reveal insights into how high-fat consumption affects insulin regulation. This unique perspective could lead to a better understanding of dietary impacts on insulin resistance.

What evidence suggests that this high-fat diet is effective for studying insulin resistance?

Research has shown that consuming a lot of fat can affect how the body uses insulin, which is crucial for controlling blood sugar. A high-fat diet may impair insulin function. This trial will investigate the effects of a hypercaloric, high-fat diet on insulin resistance. One study found that such a diet can lead to weight gain and increased body fat, but it did not alter sugar absorption. Another study suggested that eating a high-fat diet for a month can reduce the body's responsiveness to insulin, making it harder to manage sugar levels after meals. Overall, high-fat diets might decrease the body's ability to handle sugar effectively. ^{6 7 8 9 10}

Who Is on the Research Team?

Matthew D Barberio, PhD

Principal Investigator

George Washington University

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 20-45 with a BMI of 18.5-29.9, who are at low risk for medical complications and food insecurity. It's not suitable for those outside this age range or BMI, or those at higher risk based on specific health screenings.

Inclusion Criteria

I am considered low risk for complications based on a health questionnaire.

My BMI is between 18.5 and 29.9.

I am at low risk for not having enough food according to a screening.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Dietary Intervention

Participants consume a high-fat diet to decrease insulin sensitivity

3 days

Participants track diet using a mobile application

Metabolic Testing

Whole-body metabolism is measured during a standard 75-gram oral glucose tolerance test

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after dietary intervention

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hypercaloric, High Fat Diet

Trial Overview The study tests how a high-fat diet over three days affects the body's response to sugar and insulin during an oral glucose tolerance test. Participants will undergo metabolic measurements before and after the diet to see how reduced insulin sensitivity impacts metabolism.

How Is the Trial Designed?

Group I: Hypercaloric, High Fat Diet Experimental Treatment 1 Intervention

For three calendar days participants will be asked to track all foods they eat and beverages they drink (habitual diet) in a mobile application. Following the three days following the habitual diet, participants will consume 165% of their estimated daily energy needs with 65% of those calories coming from fat.

Who Is Running the Clinical Trial?

George Washington University

Lead Sponsor

Trials

263

Recruited

476,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3056941/

Consumption of a High-Fat Diet Induces Central Insulin ... These data support the conclusion that, in the presence of a HF diet, insulin is less effective. The LF and chow diets employed have comparable low fat content, ...

2. ahajournals.org ahajournals.org/doi/10.1161/ATVBAHA.120.314129

Effects of a Hypercaloric and Hypocaloric Diet on Insulin ... The hypercaloric diet increased body weight (3.5 kg; P<0.001) and fat percentage (3.5%; P<0.001) but did not affect glucose uptake nor lipolysis ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0899900721002653

Thirty days of combined consumption of a high-fat diet and ... Thirty days of combined consumption of a high-fat diet and fructose-rich beverages promotes insulin resistance and modulates inflammatory response and ...

4. mdpi.com mdpi.com/1420-3049/25/19/4369

Distinct Influence of Hypercaloric Diets Predominant with ... Overfeeding of a hypercaloric diet leads to obesity, diabetes, chronic inflammation, and fatty liver disease. Although limiting fat or carbohydrate intake ...

5. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2024.1469230/full

Short-term high-fat and high-carb diet effects on glucose ... Participants preferred high-fat milk, dairy products, and fats over low-fat options. 79% of participants consumed meat one or several times per week, and again, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6627141/

Evaluating the Impact of Different Hypercaloric Diets on ... The present investigation evaluates the impact of different hypercaloric diets and different times of exposure to diets on weight gain, insulin resistance, ...

7. academic.oup.com academic.oup.com/jcem/article/89/9/4197/2844101

Diet, Insulin Resistance, and Obesity: Zoning in on Data for ... These high-fat diets have been shown to be safe in the short term; however, their long-term safety has not been established. With respect to insulin ...

8. journals.physiology.org journals.physiology.org/doi/full/10.1152/ajpendo.00323.2016

The role of dietary fat in obesity-induced insulin resistance However, despite a similar body weight, obese high-fat diet-fed mice are more insulin resistant than mice fed an isocaloric low-fat diet.

9. sciencedirect.com sciencedirect.com/science/article/pii/S002231662201032X

Diets High in Protein or Saturated Fat Do Not Affect Insulin ... Our data support the evidence that high SF intake does not have a major impact on insulin sensitivity. Measures of biomarkers of SF and protein intake suggest ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5291812/

A high-fat, high-saturated fat diet decreases insulin sensitivity ... A diet very high in fat and saturated fat adversely affects insulin sensitivity and thereby might contribute to the development of type 2 diabetes.