Diet Modification for Obesity

(WYE Trial)

Overseen By WYE Study

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Must not be taking: Weight-loss, Appetite-altering

Disqualifiers: Diabetes, Multiple sclerosis, Anemia, 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 study how different diets affect inflammation in the brain, specifically in the area that helps control weight. Researchers will use MRI scans to detect signs of inflammation after participants follow one of three specific diet modifications. The goal is to understand how poor diet choices might lead to obesity by affecting brain regions linked to weight control. Overweight individuals willing to try a new diet plan for 14 days may be a good fit for this trial. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research on diet and brain health.

Do I have to stop taking my current medications?

The trial requires you to stop taking weight-loss medications or medications that alter appetite, like atypical anti-psychotics. Other medications are not specified, so check with the trial coordinators.

Will I have to stop taking my current medications?

The trial requires that you stop taking weight-loss medications or any medications known to alter appetite, like certain anti-psychotics. If you're on these medications, you would need to stop them to participate.

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

Research shows that changing one's diet can be important for managing obesity and is generally safe for most people.

Diet modification #1 involves very low-calorie diets (less than 800 calories a day), which require careful medical supervision to ensure safety and prevent health issues. Some studies suggest that low-carbohydrate diets can improve insulin use, benefiting those with diabetes or metabolic syndrome.

Diet modification #2 recommends using meal replacements and balanced low-calorie diets for weight loss, as clinical guidelines support. These diets are usually easy to follow and safe, focusing on reducing calorie intake while maintaining balance.

Diet modification #3 involves lifestyle changes that combine diet, exercise, and behavior therapy. These changes are considered safe and effective for managing weight, emphasizing a healthy routine with balanced eating and regular physical activity.

Overall, dietary changes are safe and well-tolerated when done correctly. Various studies and guidelines support them for managing obesity. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these diet modifications for obesity because they offer tailored approaches that aim to address individual nutritional needs and metabolic responses. Unlike standard options like calorie restriction or low-carb diets, these experimental diets focus on personalized nutrition strategies. This means they could potentially be more effective by targeting specific metabolic pathways and adapting to individual lifestyle factors, offering a more customized and potentially more sustainable solution for managing obesity.

What evidence suggests that this trial's diet modifications could be effective for obesity?

This trial will compare different diet modifications for obesity. Research has shown that dietary changes can aid in weight loss. Participants in this trial will be assigned to one of the following diets:

Diet #1 involves a structured eating plan with portion-controlled meals, which has led to noticeable weight loss. Participants in these studies lost about 2.5 to 3.0 kg over 3 to 6 months.

Diet #2 has shown mixed results, with some studies suggesting it might not significantly affect weight or body measurements like BMI.

Diet #3, similar to Diet #1, appears promising for weight loss, especially when combined with reduced calorie intake.

Overall, each diet in this trial produces different results, with some being more effective for weight loss than others. ^{1 2 6 7 8}

Who Is on the Research Team?

Ellen A Schur, MD, MS

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for overweight individuals aged 20-40 with a BMI of 25-29.9, willing to try a new diet for two weeks and undergo MRI scans. It's not suitable for those with major health issues, metal implants, extreme diets like veganism, or who are pregnant.

Inclusion Criteria

Overweight: BMI 25-29.9 kg/m2

Willing to undergo randomly assigned 14-day diet modification

I am between 20 and 40 years old.

Exclusion Criteria

Lifetime eating disorder

I have anemia or problems with my kidney or liver.

Weight > 350 pounds (MRI limit)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Diet Intervention

Participants follow a specific diet for the study

1 week

1 visit (in-person) for MRI

Follow-up

Participants are monitored for safety and effectiveness after diet intervention

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Diet modification #1
• Diet modification #2
• Diet modification #3

Trial Overview

The study tests how three different diet modifications affect brain inflammation related to obesity by using MRI scans of the hypothalamus over a period of 14 days.

How Is the Trial Designed?

Group I: Assigned Diet #3 Experimental Treatment 1 Intervention

Group II: Assigned Diet #2 Experimental Treatment 1 Intervention

Group III: Assigned Diet #1 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

Dietary counseling can lead to modest weight loss in overweight adults, with a maximum reduction of about 1.9 BMI units (approximately 6%) observed at 12 months compared to usual care.

However, the effectiveness of dietary counseling diminishes over time, with participants regaining weight at a rate of about 0.02 to 0.03 BMI units per month during maintenance phases, highlighting the need for ongoing support and effective strategies to sustain weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-analysis: the effect of dietary counseling for weight loss. Dansinger, ML., Tatsioni, A., Wong, JB., et al.[2022]

Obesity is a major global health issue linked to serious diseases like cancer and type II diabetes, making effective prevention and treatment essential.

Successful obesity management involves personalized strategies that include dietary changes, physical activity, and behavior modification, with various evidence-based approaches available such as medications, lifestyle interventions, and bariatric surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of Nutritional Strategies in the Treatment and Management of Obesity: A Systematic Review. Adeola, OL., Agudosi, GM., Akueme, NT., et al.[2023]

In a study of 66 obese women undergoing nutritional treatment for weight loss over six months, those who successfully lost weight (GL group) showed significant improvements in their diet quality, particularly in their consumption of fruits and leafy vegetables.

The group that maintained or gained weight (GG group) had higher sugar consumption both before and after treatment, highlighting the importance of reducing sugar intake to enhance weight loss outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary quality differences between women with and without weight loss in nutritional treatment. Aguiar-Bloemer, AC., Japur, CC., Francisco, LV., et al.[2020]

In a study of 96 overweight and obese adults, it was found that many participants had inadequate vitamin intake, with men particularly lacking in vitamin A and women in vitamin B1 and PP, even before starting a low-energy diet.

After 18 weeks on a low-energy diet (about 1000 kcal/day), the average intake of essential vitamins remained below recommended levels, highlighting the need for careful dietary planning to ensure adequate nutrient supply during weight loss efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Changes in vitamins intake in overweight and obese adults after low-energy diets]. Pachocka, L., Kłosiewicz-Latoszek, L.[2014]

A combination of dietary measures, including fat-reduced and carbohydrate-enhanced diets, can lead to significant weight loss in many obese patients, especially when paired with exercise and behavior modification.

If conservative methods fail after several years, adjunctive drug treatments or surgical options may be necessary for effective long-term weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Long-term weight reduction. Current therapy approaches in obesity]. Lichtenstein, S., Schulz, B., Hamann, A.[2015]

Lower-calorie diets consistently lead to greater short-term weight loss (less than 6 months) compared to higher-calorie diets, but this advantage tends to diminish over the long term (beyond 12 months).

While different macronutrient compositions (like low-carb vs. low-fat) may show short-term benefits, there are few significant long-term differences in weight loss, highlighting the importance of dietary adherence for sustained results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary interventions for obesity: clinical and mechanistic findings. Chao, AM., Quigley, KM., Wadden, TA.[2022]

A 20-week behavioral modification program for obesity involving 15 participants led to significant improvements in their dietary patterns, with most nutrients meeting or exceeding Recommended Dietary Allowances.

Participants showed increased nutrient density for several important nutrients like protein, fiber, and vitamins, while the density for carbohydrates, fat, and calcium decreased, indicating a shift towards healthier eating habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in nutrient intake during a behavioral weight control program. Ritt, RS., Jordan, HA., Levitz, LS.[2008]

Dietary modifications, such as reducing simple carbohydrates and increasing fiber intake, are effective in managing glucose levels in both type 1 and type 2 diabetes, highlighting the importance of nutrition in diabetes care.

Bariatric surgery can lead to significant weight loss and improve diabetes management, but it carries risks; meanwhile, pharmacological treatments like metformin and GLP-1 are being researched for their potential to promote weight loss and improve metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in diabetes for the millennium: nutritional therapy of type 2 diabetes. Rendel, M.[2018]

Individualized nutritional interventions led by dietitians are crucial for effective obesity management, focusing on personalized recommendations rather than general dietary information.

The approach emphasizes building a trusting relationship with patients, allowing them to actively participate in their weight loss journey, which promotes long-term sustainability of healthy eating habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of dietitian in obese patients care. Sadílková, A., Čmerdová, K., Hásková, A.[2020]

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