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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how a Western Diet, high in added sugars, affects heart health and immune function in middle-aged adults. Participants will follow the diet for 10 days while researchers monitor changes in blood vessels, gut health, and immune cells. The trial suits men and postmenopausal women aged 50-64 who are generally healthy, with stable weight and normal blood pressure, cholesterol, and blood sugar levels. As an unphased trial, it offers participants a unique opportunity to contribute to scientific understanding of diet impacts on health.

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.

What prior data suggests that the Western Diet is safe for middle-aged adults?

Research has shown that the Western Diet, high in added sugars, unhealthy fats, and processed carbs, is linked to health problems. Studies have found it can increase the risk of obesity, type 2 diabetes, and some cancers. It may also affect brain function and influence eating habits. This diet often lacks sufficient plant-based foods, which are important for maintaining health.

Although not a medicine, the long-term effects of this diet are concerning. However, for short periods, such as the 10-day study, the immediate safety risks remain less clear. The main concern is its potential impact on heart and immune health during this time.

Participants should consider these possible effects and consult a healthcare provider before joining the study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring the Western Diet as a potential treatment because it challenges the conventional wisdom around healthy eating. Unlike traditional diets that prioritize low sugar and balanced nutrients, this diet intentionally incorporates high levels of added sugars, making up 25% of the total caloric intake. The aim is to understand how such a diet impacts health over a short period, which could reveal surprising insights into diet and nutrition. This unique approach allows researchers to explore the complexities of dietary effects on health that aren't typically addressed by standard dietary guidelines.

What evidence suggests that the Western Diet could affect cardiometabolic and immune function?

Research shows that a Western Diet, often high in added sugars, can harm health. Studies have found links between this diet and weight gain, heart problems, and a higher risk of obesity. In mice, even a short-term high-fat, high-sugar diet can disrupt sugar metabolism. This diet typically contains excessive unhealthy fats and insufficient healthy ones, affecting bodily functions and increasing inflammation. These findings suggest that the Western Diet may negatively impact heart and metabolic health. ^{2 6 7 8 9}

Who Is on the Research Team?

Christopher Martens, Ph.D.

Principal Investigator

University of Delaware

Are You a Good Fit for This Trial?

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)

Heavy alcohol consumption (≥ 8 drinks/week for women and ≥ 15 drinks/week for men)

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10302286/

Global Impacts of Western Diet and Its Effects on Metabolism ...

The present review aims to describe the effect of the Western pattern diet on the metabolism, inflammation, and antioxidant status.

2.

uab.edu

uab.edu/inquiro/issues/past-issues/volume-9/the-effects-of-an-american-diet-on-health

Volume 9 | Inquiro - Journal of Undergrad Research

In addition to weight gain, a Western diet also results in impaired cardiac function in mice, as indicated by changes in contraction and relaxation of the heart ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S0002916523275462

Origins and evolution of the Western diet

The Western diet frequently contains excessive saturated and trans fatty acids and has too little n−3 PUFAs than n−6 PUFAs (97, 98, 99).

4.

stop.publichealth.gwu.edu

stop.publichealth.gwu.edu/LFD-mar19

Ultra-Processed Foods and Obesity

Ultra-processed foods, energy-dense and nutrient-poor, are linked to increased calorie intake, weight gain, higher BMI, and higher odds of abdominal obesity.

5.

nature.com

nature.com/articles/s41598-023-30254-2

Once a week consumption of Western diet over twelve ...

Our data here show that consumption of HFHS diet for 24 h impairs glucose tolerance tests in mice. This effect occurs in a shorter period as ...

6.

prevention.cancer.gov

prevention.cancer.gov/news-and-events/blog/research-highlights-how-western-style-diet-aging-may-impact-cancer-risk-intestinal-cells

How Western-Style Diet, Aging, May Impact Cancer Risk in ...

A Western-style diet causes metabolic shifts in intestinal cells, increasing tumor risk. Aging also delays maturation, but these changes are ...

7.

medicalnewstoday.com

medicalnewstoday.com/articles/western-diet

Western Diet: How it affects health, risks, and complications

The Western dietary involves excess amounts of saturated fats and refined carbohydrates and small amounts of plant-based foods.

8.

en.wikipedia.org

en.wikipedia.org/wiki/Western_pattern_diet

Western pattern diet

Health concerns​​ Based on preliminary epidemiological studies, compared to a healthy diet, the Western pattern diet is positively correlated with an elevated ...

9.

medicine.yale.edu

medicine.yale.edu/news-article/how-the-standard-american-diet-affects-your-brain/

How the Standard American Diet Affects Your Brain

Research shows multiple changes in brain circuitries occurring when animals are put on a Western diet and that these changes affect feeding behavior.