Status:
ACTIVE_NOT_RECRUITING
Methylation Diet and Lifestyle Study
Lead Sponsor:
National University of Natural Medicine
Collaborating Sponsors:
Dr. Kara Fitzgerald, ND
Metagenics, Inc.
Conditions:
Lifestyle
Diet
Eligibility:
MALE
50-72 years
Phase:
NA
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, ...
Eligibility Criteria
Inclusion
- • 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
- • 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
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT03472820
Start Date
February 1 2018
End Date
December 31 2024
Last Update
August 6 2024
Active Locations (1)
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1
NUNM Helfgott Research Institute
Portland, Oregon, United States, 97201