Methylation Diet and Lifestyle Program for Healthy Subjects
(MDL Trial)
Trial Summary
What is the purpose of this trial?
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.
Eligibility Criteria
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
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.
Follow-up
Participants are monitored for changes in quality of life, symptoms, and methylation-related biomarkers.
Treatment Details
Interventions
- Diet Recommendations
- Exercise Recommendations
- Lifestyle Recommendations
- PhytoGanix (tropical fruit flavor)
- Stress Management Recommendations
- UltraFlora Intensive Care
Find a Clinic Near You
Who Is Running the Clinical Trial?
National University of Natural Medicine
Lead Sponsor
Dr. Kara Fitzgerald, ND
Collaborator
Metagenics, Inc.
Industry Sponsor