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

42 Participants Needed

Trial Summary

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.

What data supports the idea that Diet Modification for Obesity is an effective treatment?

The available research shows that diet modification is a central part of treating obesity. Lower-calorie diets consistently lead to more weight loss in the short term compared to higher-calorie diets. While different diets may have short-term benefits, like low-carb diets being more effective than low-fat ones, the key to success is sticking to the diet. Dietitians play a crucial role by providing personalized advice, which helps people make lasting changes to their eating habits. This approach, combined with exercise and behavior changes, can lead to effective and sustainable weight loss. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment for obesity?

Research shows that dietary modifications, such as reducing calorie intake and adjusting macronutrient composition, can lead to short-term weight loss. Long-term success often depends on improving adherence to these dietary changes, and personalized nutritional therapy led by dietitians can help make these changes sustainable. ^{1 2 3 4 5}

What safety data exists for diet modification treatments for obesity?

The research indicates that dietary modification is a central component of obesity treatment, often involving caloric restriction and changes in macronutrient composition. While short-term weight loss is commonly achieved, long-term effects vary. Safety data specifically related to nutrient intake shows that some nutrients may fall below recommended levels during dietary interventions, such as iron, thiamin, and calcium. However, nutrient density for other nutrients like protein, fiber, and vitamins may increase. Overall, dietary modification is considered a primary treatment for obesity, but specific safety data on long-term nutrient adequacy and potential deficiencies should be considered. ^{1 2 6 7 8}

Is diet modification generally safe for humans?

Diet modification, including changes in nutrient intake and dietary patterns, is generally considered safe for humans. Studies have shown that it can lead to improved nutrient intake and is a key part of managing conditions like obesity and diabetes. ^{1 2 6 7 8}

Is Diet modification a promising treatment for obesity?

Yes, diet modification is a promising treatment for obesity. It is a key part of obesity treatment and can lead to weight loss by reducing calorie intake. Different diets can help people lose weight in the short term, and improving how well people stick to their diets can help with long-term weight loss. ^{1 2 6 7 9}

How is the treatment 'Diet Modification for Obesity' different from other treatments for obesity?

Diet Modification for Obesity is unique because it focuses on changing dietary patterns and energy intake, which can lead to weight loss through various mechanisms beyond just calorie restriction, such as improving dietary adherence. Unlike some treatments that rely on medication, this approach emphasizes personalized dietary changes and behavioral adjustments to achieve weight loss. ^{1 2 6 7 9}

What is the purpose of this trial?

The purpose of this study is to use magnetic resonance imaging (MRI) to evaluate the human hypothalamus for signs of inflammation in response to specific diets. This research may lead to a better understanding of how poor nutritional quality may lead to obesity through effects on regions of the brain known to regulate body weight.

Research Team

Ellen A Schur, MD, MS

Principal Investigator

University of Washington

Eligibility Criteria

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

I have anemia or problems with my kidney or liver.

Lifetime eating disorder

Weight > 350 pounds (MRI limit)

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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 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]

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]

References

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

Dietary interventions for obesity: clinical and mechanistic findings. [2022]

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

Meta-analysis: the effect of dietary counseling for weight loss. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

[Long-term weight reduction. Current therapy approaches in obesity]. [2015]

4. Czech Republic pubmed.ncbi.nlm.nih.gov

Role of dietitian in obese patients care. [2020]

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

The Effectiveness of Nutritional Strategies in the Treatment and Management of Obesity: A Systematic Review. [2023]

6. Poland pubmed.ncbi.nlm.nih.gov

[Changes in vitamins intake in overweight and obese adults after low-energy diets]. [2014]

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

Changes in nutrient intake during a behavioral weight control program. [2008]

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

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

9. England pubmed.ncbi.nlm.nih.gov

Dietary quality differences between women with and without weight loss in nutritional treatment. [2020]