Methylation Diet and Lifestyle Program for Healthy Subjects

(MDL Trial)

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: National University of Natural Medicine

Must not be taking: Proton pump inhibitors, H2-blockers

Disqualifiers: Cardiovascular, Kidney, Liver, Diabetes, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 9 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a 9-week diet and lifestyle change affects health and DNA markers in healthy men aged 50-72. The focus is on the impact of these changes on DNA methylation, a process influencing genes linked to aging and various diseases. Participants will follow specific guidelines for diet, exercise, and stress management, and take two daily supplements: PhytoGanix (a nutritional supplement) and UltraFlora Intensive Care (a probiotic supplement). This trial suits men in that age range who are ready to commit to the program and avoid certain medications and supplements. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research on lifestyle impacts on DNA, potentially benefiting future health advancements.

Do I have to stop taking my current medications for the trial?

Yes, you will need to avoid any over-the-counter medications, supplements, or herbal products during the study, except for short-term use (less than 1 week) at least 1 week before scheduled study visits. Additionally, if you are taking certain prescription medications like proton pump inhibitors or H2-blockers, you cannot participate in the trial.

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

Research shows that changing diet and exercising are generally safe and well-tolerated. The Dietary Guidelines for Americans recommend eating healthy to help prevent long-term illnesses. Health organizations worldwide recommend regular physical activity as safe for most people.

Studies also indicate that adopting healthy habits, such as managing stress and avoiding smoking or excessive drinking, can improve health. Techniques for managing stress, like meditation and exercise, are beneficial and pose no major safety concerns.

The trial's supplements, PhytoGanix and UltraFlora Intensive Care, are considered safe. PhytoGanix, a blend of organic fruits and vegetables, supports overall health and is non-GMO, gluten-free, and sugar-free. UltraFlora Intensive Care, a probiotic, supports gut health. Probiotics are safe for most people, though some may experience mild stomach upset.

Overall, the treatments in this program have a good safety record based on existing research and guidelines. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Methylation Diet and Lifestyle Program because it takes a holistic approach to improving health through diet, exercise, lifestyle changes, and stress management, combined with specific nutritional supplements like PhytoGanix and UltraFlora Intensive Care. Unlike conventional treatments that might focus solely on medication or isolated lifestyle changes, this program integrates multiple factors believed to collectively enhance well-being. The unique aspect lies in its emphasis on methylation, a biochemical process crucial for gene expression and overall health, potentially offering benefits that standard treatments do not address. By focusing on these interconnected lifestyle elements, researchers hope to uncover how a comprehensive approach can lead to improved health outcomes.

What evidence suggests that this trial's treatments could be effective for influencing DNA methylation?

Research has shown that certain lifestyle habits, such as diet and exercise, can positively influence gene activity through DNA methylation. For instance, one study found that diets like the DASH diet can improve metabolic health by affecting these DNA patterns. Stress, diet, and exercise also impact DNA methylation, potentially slowing aging. In this trial, participants in the intervention group will receive recommendations on diet, lifestyle, exercise, and stress management, along with supplements like PhytoGanix and UltraFlora Intensive Care. PhytoGanix provides antioxidants and supports gut health, potentially improving overall health. UltraFlora Intensive Care enhances gut health and supports the body's natural functions. Together, these interventions aim to promote better health by positively affecting gene activity and supporting overall wellness. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This study is for healthy English-speaking men aged 50-72 who are willing to follow a specific diet and lifestyle program for 9 weeks. Participants must be able to use electronic devices, avoid certain over-the-counter products, track their daily food intake, sleep, stress management techniques, exercise, and take part in blood and saliva sampling.

Inclusion Criteria

Willing and able to use electronic devices and connect to the internet

I agree not to take any over-the-counter meds, supplements, or herbal products during the study.

This person is willing to track their food intake, sleep, stress management techniques, and exercise every day.

Exclusion Criteria

I am currently taking medication for stomach acid.

I have been diagnosed with a major health condition like heart, kidney, liver disease, diabetes, autoimmune disease, high blood pressure, or cancer.

You drink too much alcohol (more than 4 drinks per day or 14 per week on average).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 9-week diet and lifestyle intervention, including diet, lifestyle, exercise, and stress management recommendations, along with taking two different supplements twice daily.

9 weeks

Follow-up

Participants are monitored for changes in quality of life, symptoms, and methylation-related biomarkers.

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Diet Recommendations
• Exercise Recommendations
• Lifestyle Recommendations
• PhytoGanix (tropical fruit flavor)
• Stress Management Recommendations
• UltraFlora Intensive Care

Trial Overview The trial tests the impact of a 9-week diet and lifestyle intervention on quality of life and DNA methylation-related biomarkers. It includes dietary changes, exercise routines, stress management practices along with consuming a tropical fruit-flavored nutrient beverage called PhytoGanix and taking UltraFlora Intensive Care probiotics.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 6 Interventions

The intervention will be diet, lifestyle, exercise and stress management recommendations combined with taking two different supplements twice daily, in divided doses.

Group II: Control Group Active Control 1 Intervention

The control group will undergo the same testing measures as the intervention group, but will not have access to the education information or be instructed to change diet or lifestyle factors. They will have access to the information after the study is complete.

Who Is Running the Clinical Trial?

National University of Natural Medicine

Lead Sponsor

Trials

34

Recruited

1,400+

Dr. Kara Fitzgerald, ND

Collaborator

Trials

1

Recruited

40+

Metagenics, Inc.

Industry Sponsor

Trials

15

Recruited

1,400+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12408607/

Epigenetic modulation by life–style: advances in diet, exercise ... These results indicate that the DASH diet may serve as an effective intervention for enhancing metabolic health through epigenetic regulation, potentially ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1568163723001150

Stress, diet, exercise: Common environmental factors and ... This review explores the effects of modifiable lifestyle factors' on the global DNA methylation landscape, as seen by aging clocks.

3. aging-us.com aging-us.com/article/206240/pdf

Dietary associations with reduced epigenetic age The main objective of this research is to investigate diet as one potential contributor to the observed variability in epigenetic age changes, ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03472820

NCT03472820 | Methylation Diet and Lifestyle Study The intervention will be diet, lifestyle, exercise and stress management recommendations combined with taking two different supplements twice daily, in divided ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9953584/

Restoring Epigenetic Reprogramming with Diet and Exercise ... Here, we describe the potential role of diet and exercise as therapeutic epigenetic strategies for health and diseases, highlighting putative future ...

6. dietaryguidelines.gov dietaryguidelines.gov/sites/default/files/2020-12/Dietary_Guidelines_for_Americans_2020-2025.pdf

2020-2025 Dietary Guidelines for Americans, 2020-2025. 9th Edition. December 2020. Available at DietaryGuidelines.gov. In accordance with ... Adolescent Nutrition ...

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK587401/

The Role of Dietary Lifestyle Modification in Chronic Disease ... Dietary lifestyle modification is a cornerstone of preventive medicine and chronic disease management. Strong evidence links poor nutrition to the rising ...

8. cdc.gov cdc.gov/nutrition/php/public-health-strategy/food-service-and-nutrition-guidelines.html

Strategies for Food Service and Nutrition Guidelines Applying food service or nutrition guidelines can improve healthy food choices where foods and beverages are sold, served, and distributed.

9. sciencedirect.com sciencedirect.com/science/article/pii/S0022316624004759

Perspective: Key Considerations When Developing and ... This perspective paper aimed to explore several proposed best practice guidelines when developing nutrition interventions to improve dietary adherence within ...

10. fns.usda.gov fns.usda.gov/cnpp/dietary-guidelines-americans

Dietary Guidelines for Americans The Dietary Guidelines provides food-based recommendations to promote health, help prevent diet-related chronic diseases, and meet nutrient needs.