Western Diet for Healthy Eating

(WD Trial)

Overseen By Kevin Decker, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Delaware

Must not be taking: Fibrates, Statins, Benzodiazepines, others

Disqualifiers: Diabetes, Heart failure, Schizophrenia, others

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

Compensation: Varies

Number of Visits: 3

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will implement a Western Diet (WD) to understand cardiometabolic and immune function in middle-aged adults (50- 64 years old). Vascular health, intestinal permeability, and T-cell function will be examined before, during, and after the WD. The WD is a 10-day diet and will consist of 25% of total energy from added sugars.

Will I have to stop taking my current medications?

The trial requires that you do not take medications or supplements that lower blood triglycerides or cholesterol, or medications affecting vascular or central nervous system functions. If you are on such medications, you may need to stop them to participate.

Is the Western Diet generally safe for humans?

The Western Diet, also known as the Standard American Diet, is linked to health risks such as metabolic disorders, heart disease, and liver problems. It is associated with increased risk of breast cancer and non-alcoholic fatty liver disease. ^{1 2 3 4 5}

How does the Western Diet treatment differ from other treatments for healthy eating?

The Western Diet is unique because it is characterized by high calorie intake with a high proportion of simple sugars and processed foods, which is linked to increased risks of chronic diseases like diabetes, obesity, and cardiovascular diseases. Unlike other healthy eating treatments that focus on balanced nutrition, the Western Diet is associated with negative health outcomes. ^{1 2 4 5 6}

Research Team

Christopher Martens, Ph.D.

Principal Investigator

University of Delaware

Eligibility Criteria

This trial is for middle-aged adults between the ages of 50 and 64 who are interested in understanding how a Western Diet affects heart health, gut function, and immune system. Specific eligibility criteria details were not provided.

Inclusion Criteria

Ability to provide informed consent

Systolic blood pressure < 130 mmHg; diastolic blood pressure < 90 mmHg

Body mass index (BMI) < 30 kg/m2 and % body fat < 25% for men and < 33% for women

Exclusion Criteria

I am currently taking medication or supplements to lower my cholesterol or triglycerides.

Major psychiatric disorder (e.g. schizophrenia, bipolar disorder)

I am not on medications that affect my brain function.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Western Diet Implementation

Participants consume a Western Diet high in added sugars for 10 days

10 days

3 visits (in-person) for measurements before, during, and after diet

Follow-up

Participants are monitored for changes in cardiometabolic and immune function after the Western Diet

4-6 weeks

Treatment Details

Interventions

• Western Diet

Trial Overview The study tests the effects of a Western Diet on participants' cardiovascular health, intestinal permeability (how easily substances pass through the gut lining), and T-cell function (a type of white blood cell important for immunity).

Participant Groups

Group I: Western Diet Experimental Treatment 1 Intervention

Consumption of 10 days of a diet high in added sugars (25% of total caloric intake)

Who Is Running the Clinical Trial?

University of Delaware

Lead Sponsor

Trials

167

Recruited

25,700+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials

315

Recruited

251,000+

Findings from Research

A diet lower in saturated fatty acids (palmitic acid) and higher in monounsaturated fatty acids (oleic acid) led to a significant increase in physical activity, with participants being 12-15% more active on average during the high-oleic acid diet compared to the high-palmitic acid diet.

The high-oleic acid diet also resulted in a higher resting energy expenditure (REE) by 3-4.5%, and was associated with lower levels of anger and hostility, suggesting that dietary fat composition can influence both physical activity and mood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Substituting dietary monounsaturated fat for saturated fat is associated with increased daily physical activity and resting energy expenditure and with changes in mood. Kien, CL., Bunn, JY., Tompkins, CL., et al.[2023]

In a study involving 319,826 women over an average follow-up of 8.8 years, no consistent link was found between the consumption of meat, eggs, or dairy products and breast cancer risk.

However, high processed meat consumption showed a slight increase in breast cancer risk, and butter consumption was associated with increased risk specifically in premenopausal women, suggesting that dietary factors may still play a role in breast cancer risk, particularly with cooking methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meat, eggs, dairy products, and risk of breast cancer in the European Prospective Investigation into Cancer and Nutrition (EPIC) cohort. Pala, V., Krogh, V., Berrino, F., et al.[2023]

Women can adopt several key strategies for healthy eating, such as focusing on unsaturated fats, whole grains, and a variety of fruits and vegetables while limiting unhealthy fats and sugary drinks.

These dietary principles are beneficial throughout all life stages, including young adulthood, pregnancy planning, and aging, and taking a multivitamin with folic acid and vitamin D can provide additional nutritional support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Essentials of healthy eating: a guide. Skerrett, PJ., Willett, WC.[2022]

A hyperglucidic diet led to significant hepatic fat deposition in adult male Wistar rats, with 83% of livers showing lipid vacuoles after 21 days, indicating a clear link to steatosis.

Despite the fat accumulation in the liver, oxidative stress markers like malondialdehyde and reduced glutathione remained unchanged, suggesting that the observed liver changes were not due to inflammation or fibrosis, but a notable reduction in vitamin E levels was found, highlighting a potential deficiency in antioxidants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experimental induction of steatosis in different tissues after the ingestion of a carbohydrate-rich diet: effect on the liver, on the heart and on indicators of oxidation. Haubert, NJ., Padovan, GJ., Zucoloto, S., et al.[2019]

In a study with rats fed a western diet for 6 months, those supplemented with vitamin D3 showed a significant reduction in hepatic steatosis, with only 27% of liver cells affected compared to 61% in those without supplementation.

Vitamin D3 supplementation also improved insulin sensitivity and reduced blood pressure and left ventricular mass, indicating its potential protective effects against liver and cardiovascular damage caused by a high-fat diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary supplementation of vitamin D prevents the development of western diet-induced metabolic, hepatic and cardiovascular abnormalities in rats. Mazzone, G., Morisco, C., Lembo, V., et al.[2022]

A Western diet, which is high in energy-dense and processed foods, significantly increases the risk of developing chronic diseases such as diabetes, obesity, and cardiovascular diseases.

This dietary pattern is linked to negative health outcomes, highlighting the importance of dietary choices in preventing chronic health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gut Microbiota: An Important Link between Western Diet and Chronic Diseases. Shi, Z.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Substituting dietary monounsaturated fat for saturated fat is associated with increased daily physical activity and resting energy expenditure and with changes in mood. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Meat, eggs, dairy products, and risk of breast cancer in the European Prospective Investigation into Cancer and Nutrition (EPIC) cohort. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Essentials of healthy eating: a guide. [2022]

4. Brazil pubmed.ncbi.nlm.nih.gov

Experimental induction of steatosis in different tissues after the ingestion of a carbohydrate-rich diet: effect on the liver, on the heart and on indicators of oxidation. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Dietary supplementation of vitamin D prevents the development of western diet-induced metabolic, hepatic and cardiovascular abnormalities in rats. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Gut Microbiota: An Important Link between Western Diet and Chronic Diseases. [2020]