Clinical trial NCT03472820: Methylation Diet and Lifestyle Study
Official title: The Effects of Diet and Lifestyle on Quality of Life and Methylation-related Biomarkers in Vivo.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lifestyle
Diet
Healthy
Keywords: Diet
Lifestyle
DNA methylation
Lead sponsor: National University of Natural Medicine
Sponsor class: OTHER
Collaborators: name: Dr. Kara Fitzgerald, ND
name: Metagenics, Inc.
First posted: 2018-03-21
Enrollment: 44
Sex: MALE
Minimum age (years): 50
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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.


Eligibility criteria: Inclusion Criteria:

* • Males, ages 50-72

  * Willing to adhere to 9 weeks of a dietary and lifestyle program including specific nutrition and exercise guidelines
  * Willing to avoid any over-the-counter medications, supplements or herbal products for the length of the study, except short-term use (\<1 week) use at least 1 week before scheduled study visits
  * Willing to have blood drawn three times and abstain from food or beverage intake for 10-12 hours before blood draws
  * Willing to provide saliva samples
  * Willing to track food intake, sleep, stress management techniques, and exercise daily
  * Willing to drink a nutrient-enriched beverage and take a encapsulated probiotic daily
  * Willing and able to use electronic devices and connect to the internet
  * Able to speak, read and understand English

Exclusion Criteria:

* • Currently taking any of the following prescription medications

  * Proton pump inhibitors: omeprazole (Prilosec, Prilosec OTC); aspirin and omeprazole (Yosprala); lansoprazole (Prevacid, Prevacid IV, Prevacid 24-Hour); ;dexlansoprazole (Dexilent, Dexilent Solutab); rabeprazole (Aciphex, Aciphex Sprinkle); pantoprazole (Protonix)
  * H2-blockers: nizatidine (Axid, Axid AR, Axid Pulvules); famotidine (Pepcid, Pepcid AC); cimetidine (Tagamet, Tagamet HB); ranitidine (Zantac)
  * These classes of medications are excluded due to direct (due to nutrient requirements for metabolism) and indirect (through impaired digestion and assimilation of nutrients).

    * Use of nutrition supplements or herbal products not prescribed by a licensed healthcare provider for a medical condition
    * Currently following a prescribed dietary/lifestyle program or initiate within the 30 days prior to baseline
    * Initiation of or changes to an exercise regimen within 30 days prior to baseline
    * Use of nicotine, marijuana or cannabinoids (including CBD products) or recreational drugs/substances (such as but not limited to cocaine, phencyclidine \[PCP\], and methamphetamine) current/within the last 30 days or use during the study
    * Have a diagnosis of cardiovascular disease, kidney disease, liver disease, diabetes, autoimmune disease, high blood pressure, or cancer (does not include basal cell carcinoma, squamous cell carcinoma, and/or carcinoma in situ of the cervix).
    * Have a diagnosis of an immunodeficiency condition, such as Human Immunodeficiency Virus (HIV) infection or Acquired Immune Deficiency Syndrome (AIDS)
    * Have a diagnosis of neurodegenerative conditions such as, amyotrophic lateral sclerosis (ALS), Parkinson's disease, Multiple Sclerosis, or Alzheimer's disease.
    * Excessive alcohol consumption (more than 4 drinks per day or 14 per week on average)
    * Known sensitivity, intolerance or allergy to ingredients in the study supplements or in the recommended dietary therapy
    * Currently receiving intravenous nutrient therapy
    * Currently participating in another interventional research study or participated in another interventional study within the last 3 weeks prior to baseline

Primary outcomes:
measure: Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29)
timeFrame: 8 weeks
Secondary outcomes:
measure: Measure Yourself Medical Outcome Profile (MYMOP)
timeFrame: 8 weeks
measure: National University of Natural Medicine Multi-system Symptom/Adverse Event Questionnaire
timeFrame: 8 weeks
Other outcomes:
measure: Infinium Methylation EPIC Index by Illumina
timeFrame: 8 weeks
measure: Methylation Profile by Doctor's Data
timeFrame: 8 weeks
measure: Folate Vitamer Panel by Doctor's Data
timeFrame: 8 weeks
measure: Medical Symptom Questionnaire (MSQ)
timeFrame: 8 weeks
measure: DNA Methylation Pathway Profile by Doctor's Data
timeFrame: 8 weeks
Locations:
city: Portland
country: United States
facility: NUNM Helfgott Research Institute
state: Oregon
Study officials:
References: