Clinical Trial

Methylation Diet and Lifestyle Study

Study acronym: MDL
Active, Not Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2018-03-12; most recent amendment 2024-08-02.
Status change: Recruiting → Active, Not Recruiting 2019-07-30
Trial Details
NCT Number NCT03472820
Lead Sponsor National University of Natural Medicine
Collaborators: Dr. Kara Fitzgerald, ND, Metagenics, Inc.
Conditions Lifestyle, Diet, Healthy
Enrollment 44 participants
Start Date 2018-02-01
Primary Completion 2020-12-31 (estimated)
Study Completion 2024-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-08-06