Mayo Clinic Diet for Obesity

Overseen By Family Medicine Research Study Coordinators

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Weight loss medications

Disqualifiers: Cancer, Breastfeeding, Pregnant, Diabetes, others

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

Compensation: Varies

Number of Visits: 24

Duration: 12 weeks

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of the Mayo Clinic Diet in achieving significant weight loss compared to usual care methods. Researchers seek to determine if the diet enables participants to lose more than 5% of their body weight and assess its impact on body composition and quality of life over time. The trial is suitable for English-speaking adults with a BMI of 25 or higher who have not recently lost 5% or more of their weight and are not currently managing diabetes or undergoing other weight loss treatments. Participants will either begin with the Mayo Clinic Diet or receive resources for lifestyle changes, switching groups after 12 weeks. As an unphased trial, this study offers participants the opportunity to contribute to valuable research on weight loss strategies.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you are taking weight loss medications, you would not be eligible to participate.

What prior data suggests that the Mayo Clinic Diet is safe for weight loss?

Research has shown that the Mayo Clinic Diet is safe for most adults. This diet emphasizes consuming plenty of fruits and vegetables, which is generally healthy. No reports of serious side effects have emerged from this diet. It does not require eliminating major food groups, making it easier for most people to follow. Overall, the Mayo Clinic Diet is recognized for its balanced approach to weight loss and healthy eating. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mayo Clinic Diet for obesity because it emphasizes personalized lifestyle changes rather than relying solely on medication or surgery, which are common current options. This diet plan provides users with a comprehensive guide through the Mayo Clinic Diet book or app, focusing on sustainable healthy eating and regular physical activity. Additionally, the program is designed to be adaptable and supportive, offering tools for self-monitoring and motivation, which can empower individuals to make long-term changes to their lifestyle.

What evidence suggests that the Mayo Clinic Diet might be an effective treatment for obesity?

Research has shown that the Mayo Clinic Diet can lead to significant weight loss. Some studies have found that individuals on this diet can lose more than 5% of their body weight. In this trial, participants in the Mayo Clinic Diet arm will follow the diet for 12 weeks. By emphasizing lifestyle changes, the diet makes it easier to maintain weight loss over time. Most participants experience the greatest weight loss within 6 to 12 months. Additionally, the Mayo Clinic Diet helps reduce waist size and improve health measures, such as lowering triglycerides, which are fats in the blood. ^{1 6 7 8 9}

Who Is on the Research Team?

Tamim Rajjo

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals who are experiencing severe weight loss or obesity and are looking to achieve clinically significant weight loss. Participants should be interested in following the Mayo Clinic Diet compared to their usual care routine.

Inclusion Criteria

Ability to read and understand English (as the Mayo Clinic Diet book and app are only available in English)

My BMI is 25 or higher.

Exclusion Criteria

Currently breastfeeding

I have been diagnosed with melanoma or another type of cancer.

Pregnant, or planned to be pregnant within 6 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow the Mayo Clinic Diet or usual care for 12 weeks

12 weeks

Regular check-ins (frequency not specified)

Crossover

Participants switch from Mayo Clinic Diet to usual care or vice versa

12 weeks

Follow-up

Participants are monitored for sustainability of weight loss and quality of life changes

28 weeks

Assessments at 24 and 52 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mayo Clinic Diet

Trial Overview The study tests the effectiveness of the Mayo Clinic Diet in achieving more than 5% weight loss against typical dietary habits (usual care). It will assess how practical this diet is, any obstacles faced, its long-term viability at 24 and 52 weeks, changes in body composition, and life quality improvements.

How Is the Trial Designed?

Group I: Mayo Clinic Diet Experimental Treatment 2 Interventions

Subjects in the Mayo Clinic Diet (MCD) arm will be provided with options including the Mayo Clinic Diet book 3rd edition or application from digital wellness or both with full subscription paid for by the Mayo Clinic Diet for the 12 week period. The Mayo Clinic Diet arm will switch to usual care after 12 weeks.

Group II: Usual Care Active Control 2 Interventions

Subjects in the usual care arm will be provided with two Mayo Clinic resources for lifestyle modifications: Eat Well Use the Plate hand out, and the Food, Physical Activity and Weight Tracking Apps with a list of self-monitoring tools to support a healthy lifestyle. The usual care arm will switch to the Mayo Clinic Diet after 12 weeks.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

The DASH diet, which emphasizes fruits, vegetables, and low-fat dairy, has been shown to effectively lower blood pressure in individuals with prehypertension and stage I hypertension, based on findings from the DASH trial.

While the DASH diet is generally safe for most patients, caution is advised for those with chronic kidney or liver diseases, and modifications may be needed for individuals with chronic heart failure, uncontrolled diabetes, lactose intolerance, or celiac disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Dietary Approaches to Stop Hypertension (DASH) eating pattern in special populations. Tyson, CC., Nwankwo, C., Lin, PH., et al.[2021]

In a study involving 53 overweight patients, those following a healthy eating diet lost an average of 6.0 kg over 12 weeks, which was significantly more than the 4.2 kg lost by those on an energy prescription diet.

Both dietary approaches resulted in clinically significant weight loss, but the healthy eating diet proved to be more effective, suggesting the need for further research to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Controlled clinical trial of two weight reducing diets in a NHS hospital dietetic outpatient clinic - a pilot study. Taylor, FC., Irons, LJ., Finn, P., et al.[2019]

Weight reduction is crucial for managing obesity and its related conditions like diabetes and hypertension, and both high-carbohydrate/low-fat and higher-protein/low-carbohydrate diets can lead to fat loss if calorie intake is sufficiently low.

For bariatric patients, low-calorie diets, protein-sparing modified fasts, and modified-carbohydrate diets are the most effective for compliance and long-term weight maintenance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The diet prescription for obesity. What works? Holtmeier, KB., Seim, HC.[2005]

The Mediterranean diet is strongly supported by evidence showing significant reductions in mortality rates and heart attack occurrences, making it a highly recommended option for patients aiming to reduce cardiovascular disease risk.

While popular diets like Atkins and South Beach are effective for weight loss, they lack substantial evidence for long-term health benefits, highlighting the importance of focusing on patient-oriented outcomes in dietary counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diets for cardiovascular disease prevention: what is the evidence? Walker, C., Reamy, BV.[2022]

In a study involving 53 overweight patients, those following a healthy eating diet lost an average of 6.0 kg over 12 weeks, which was significantly more than the 4.2 kg lost by those on an energy prescription diet.

Both dietary approaches resulted in clinically significant weight loss, but the healthy eating diet proved to be more effective, suggesting the need for further research to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Controlled clinical trial of two weight reducing diets in a NHS hospital dietetic outpatient clinic: a pilot study. Taylor, F., Irons, L., Finn, P., et al.[2007]

Citations

1. mayoclinic.org mayoclinic.org/healthy-lifestyle/weight-loss/in-depth/mayo-clinic-diet/art-20045460

The Mayo Clinic Diet: A weight-loss program for life The Mayo Clinic Diet is a lifestyle approach to weight loss that can help you maintain a healthy weight for a lifetime. By Mayo Clinic Staff.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11532308/

Efficacy of in-person versus digital enhanced lifestyle ... Several studies have shown that with behavioral interventions, participants achieved maximal weight loss between 6 and 12 months [5,27,28]. Real ...

3. mayo.edu mayo.edu/research/clinical-trials/cls-20579515

Weight Loss Through Mayo Clinic Diet The purpose of study is to evaluate the efficacy of the Mayo Clinic Diet in clinically significant weight loss (\>5%) versus usual care.

4. mayoclinic.org mayoclinic.org/healthy-lifestyle/weight-loss/basics/mayo-clinic-diet/hlv-20049483

Weight loss The Mayo Clinic Diet The Mayo Clinic Diet is a different approach to weight loss. First, the Mayo Clinic Diet is based on research and clinical experience.

5. newsnetwork.mayoclinic.org newsnetwork.mayoclinic.org/discussion/mayo-clinic-researchers-pave-the-way-for-individualized-obesity-therapy-tailoring-interventions-to-a-persons-needs/

Mayo Clinic researchers pave the way for individualized ... The phenotype-focused group of patients had more significant weight loss, reduced waist circumference, reduced triglycerides, reduced daily ...

6. mayoclinic.org mayoclinic.org/healthy-lifestyle/nutrition-and-healthy-eating/expert-answers/high-protein-diets/faq-20058207

High-protein diets: Are they safe? Diets high in protein aren't known to cause medical problems in healthy people. But there are a wide range of these types of diets.

7. mayoclinic.org mayoclinic.org/diseases-conditions/obesity/diagnosis-treatment/drc-20375749

Obesity - Diagnosis and treatment Eat small amounts of fats, and make sure they come from heart-healthy sources, such as olive, canola and nut oils. Restricting certain foods.

8. mayo.edu mayo.edu/research/clinical-trials/diseases-conditions/obesity

Obesity Clinical Trials The purpose of this study is to explore the effectiveness and safety of a modified gastroplication technique for weight loss in five patients with obesity, and ...

9. mayoclinicproceedings.org mayoclinicproceedings.org/article/S0025-6196(11)64159-1/fulltext

Safe and Effective Management of the Obese Patient Obesity negatively influences an individual's health by increasing mortality and raising the risk for multiple medical conditions such as type 2 diabetes ...