Start: February 1, 2018
End: December 31, 2022
What Is This Study About?
This study will evaluate a 9-week diet and lifestyle intervention in healthy older adult men to test whether short-term changes can affect DNA methylation. Methylation is an epigenetic change that affects the way genes function and has been associated with dementia and other conditions, including diabetes and cancer.
Do I Qualify To Participate in This Study?
- Able to use electronic devices and connect to the Internet
- Able to speak, read, and understand English
Must NOT have:
- Prohibited medications: proton pump inhibitors, including omeprazole (Prilosec), aspirin and omeprazole (Yosprala), lansoprazole (Prevacid), dexlansoprazole (Dexilent), rabeprazole (AcipHex), and pantoprazole (Protonix); and H2 blockers, including nizatidine (Axid), famotidine (Pepcid), cimetidine (Tagamet), and ranitidine (Zantac)
- Use of over-the-counter medications, or nutritional supplements or herbal products not prescribed by a licensed healthcare provider for a medical condition (except for short-term use of less than 1 week)
- Currently following a prescribed dietary/lifestyle program or plan to initiate one
- Initiation of or changes to an exercise routine within 30 days prior to baseline
- Use of nicotine, marijuana, cannabinoids, or other recreational drugs/substances, including cocaine, phencyclidine (PCP), and methamphetamines in past 30 days or during the study
- Heart 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)
- Immunodeficiency condition, such as an HIV (human immunodeficiency virus) infection or AIDS (acquired immune deficiency syndrome)
- Neurodegenerative condition, such as amyotrophic lateral sclerosis, Parkinson's disease, multiple sclerosis, or Alzheimer's disease
- More than 4 alcoholic drinks per day or 14 per week, on average
- Known sensitivity, intolerance, or allergy to study supplements or diet
- Receiving intravenous nutrient therapy
- Participation in another interventional research study within 3 weeks of baseline
Ryan Bradley, ND
Kara Fitzgerald, ND
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.
Where Is This Study Located?
NUNM Helfgott Research Institute
Portland, OR 97201
Lead: National University of Natural Medicine
Dr. Kara Fitzgerald, ND
Source: ClinicalTrials.gov ID: NCT03472820