Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
44 participants
INTERVENTIONAL
2018-02-01
2024-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Intervention Group
The intervention will be diet, lifestyle, exercise and stress management recommendations combined with taking two different supplements twice daily, in divided doses.
Diet Recommendations
Specific dietary guidelines will be outlined for participants.
Lifestyle Recommendations
Participants are encouraged to average a minimum of 7 hours of sleep per night.
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.
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.
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.
UltraFlora Intensive Care
Probiotic; Participants will take 2 capsules of UltraFlora Intensive Care probiotic daily in divided doses.
Control Group
The control group will undergo the same testing measures as the intervention group, but will not have access to the education information or be instructed to change diet or lifestyle factors. They will have access to the information after the study is complete.
No interventions assigned to this group
Interventions
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Diet Recommendations
Specific dietary guidelines will be outlined for participants.
Lifestyle Recommendations
Participants are encouraged to average a minimum of 7 hours of sleep per night.
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.
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.
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.
UltraFlora Intensive Care
Probiotic; Participants will take 2 capsules of UltraFlora Intensive Care probiotic daily in divided doses.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
72 Years
MALE
Yes
Sponsors
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Dr. Kara Fitzgerald, ND
UNKNOWN
Metagenics, Inc.
INDUSTRY
National University of Natural Medicine
OTHER
Responsible Party
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Locations
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NUNM Helfgott Research Institute
Portland, Oregon, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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RB100217
Identifier Type: -
Identifier Source: org_study_id
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