Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT03472820
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
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
50 Years
Maximum Age:
72 Years
Study:
NCT03472820
Study Brief:
Protocol Section:
NCT03472820