Methylation Diet and Lifestyle Study

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

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.

Sponsors & Collaborators

• Dr. Kara Fitzgerald, ND

  collaborator UNKNOWN

• Metagenics, Inc.

  collaborator INDUSTRY

• National University of Natural Medicine

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

72 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-02-01

Primary Completion

2020-12-31

Completion

2024-12-31

Countries

• United States

Study Locations