NCT03472820

Methylation Diet and Lifestyle Study

The Effects of Diet and Lifestyle on Quality of Life and Methylation-related Biomarkers in Vivo.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: National University of Natural Medicine · Academic / Other
• Sex: Male
• Age: 50 Years – 72 Years
• Healthy volunteers: Accepted

Summary

The maintenance of health and the progression of disease are associated with an individual's genetic make-up and environmental factors, including lifestyle choices (such as diet, exercise, behaviors, stressors, sleep, tobacco and alcohol use), environmental exposures and socioeconomic determinants. Environmental factors have been shown to influence, sometimes rapidly, epigenetic processes thereby influencing genetic expression. Regulation of the human genome by the epigenome is now regarded as a cornerstone, heritable, physiologic process, playing a key role in phenotypic expression of health and disease. DNA methylation is a well-researched, primary epigenetic process. Aberrant DNA methylation resulting in hyper- or hypomethylated regions of the genome, generally results in inhibition or expression of certain genes and has been associated with the pathogenesis of numerous conditions, ranging from inflammation and accelerated aging, to cancer, autoimmunity, diabetes, heart disease, dementia, allergic disease, posttraumatic stress disease and others. Likewise, certain healthy diet and lifestyle habits have been demonstrated to favorably influence DNA methylation patterns. Understanding that environmental factors can potently and sometimes rapidly, favorably or negatively influence epigenetic expression, a short-term diet and lifestyle intervention may significantly augment DNA methylation expression. The purpose of this study is to evaluate a 9-week diet and lifestyle intervention on patient-reported quality of life, symptoms, and DNA and biochemical methylation-related biomarkers in healthy males ages 50-72.

Conditions

• Lifestyle
• Diet
• Healthy

Interventions

Type	Name	Description
OTHER	Diet Recommendations	Specific dietary guidelines will be outlined for participants.
OTHER	Lifestyle Recommendations	Participants are encouraged to average a minimum of 7 hours of sleep per night.
OTHER	Exercise Recommendations	Participants will be encouraged to exercise a minimum of 30 minutes at least 5 days per week at an intensity of 60-80% of maximum perceived exertion.
OTHER	Stress Management Recommendations	Participants will utilize the Cleveland Clinic's Stress Free Now application to engage in a variety of guided stress reduction techniques, including meditation and mindful breathing. Recommended frequency is twice daily, preferably morning and evening.
OTHER	PhytoGanix (tropical fruit flavor)	Organic Superfruits \& Greens Powder Drink Mix is a food-based phytonutrient blend. Participants will take 2 servings daily in divided doses.
OTHER	UltraFlora Intensive Care	Probiotic; Participants will take 2 capsules of UltraFlora Intensive Care probiotic daily in divided doses.

Timeline

• Start date: 2018-02-01
• Primary completion: 2020-12-31
• Completion: 2024-12-31
• First posted: 2018-03-21
• Last updated: 2024-08-06

Locations

1 site across 1 country: United States