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

150 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of study is to evaluate the efficacy of the Mayo Clinic Diet in clinically significant weight loss (\>5%) versus usual care. We also wish to evaluate the feasibility, barriers to completion, and sustainability of this intervention at the 24, and 52-week marks. Lastly, we aim to study the change in participants body composition and quality of life at the end of this intervention.

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 data supports the effectiveness of the treatment Mayo Clinic Diet for Obesity?

Research shows that weight-reducing diets, especially those low in fat, can lower the risk of early death in adults with obesity. These diets may also help reduce the risk of heart-related issues and improve overall health. ^{1 2 3 4 5}

Is the Mayo Clinic Diet for Obesity safe for humans?

Weight loss diets, including those low in fat, are generally safe and can reduce the risk of early death in adults with obesity. However, very-low-calorie diets should be used cautiously and only for short periods due to potential side effects. The DASH diet, which shares similarities with the Mayo Clinic Diet, is safe for most people but may need adjustments for those with certain health conditions. ^{5 6 7 8 9}

How is the Mayo Clinic Diet treatment for obesity different from other treatments?

The Mayo Clinic Diet is unique because it focuses on a comprehensive approach that includes nutrition education, behavior modification, and increased activity, rather than just calorie restriction. This holistic method aims for sustainable weight loss and maintenance, setting it apart from more restrictive diets like very-low-calorie or ketogenic diets. ^{3 8 10 11 12}

Research Team

Tamim Rajjo

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Controlled clinical trial of two weight reducing diets in a NHS hospital dietetic outpatient clinic: a pilot study. [2007]

2. England pubmed.ncbi.nlm.nih.gov

Controlled clinical trial of two weight reducing diets in a NHS hospital dietetic outpatient clinic - a pilot study. [2019]

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

Diets for cardiovascular disease prevention: what is the evidence? [2022]

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

Medical nutrition therapy for the treatment of obesity. [2019]

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

Effects of weight loss interventions for adults who are obese on mortality, cardiovascular disease, and cancer: systematic review and meta-analysis. [2022]

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

The Effect of a Digital Behavioral Weight Loss Intervention on Adherence to the Dietary Approaches to Stop Hypertension (DASH) Dietary Pattern in Medically Vulnerable Primary Care Patients: Results from a Randomized Controlled Trial. [2020]

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

The Dietary Approaches to Stop Hypertension (DASH) eating pattern in special populations. [2021]

8. Canada pubmed.ncbi.nlm.nih.gov

Diet in the management of weight loss. [2018]

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

Weight loss with a low-carbohydrate, Mediterranean, or low-fat diet. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Ketogenic diet as an advanced option for the management of pediatric obesity. [2023]

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

A comprehensive approach to outpatient obesity management. [2009]

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

The diet prescription for obesity. What works? [2005]