Healthy Elder People
Conditions
Keywords
ferulic acid, antioxidant, antiinflammatory, healthy elder people
Brief summary
To determine if Feru-guard, a dietary supplement, can decrease general oxidation and inflammation in people who are ages 65-89 years old. Also to determine if Feru-guard is safe in older people when given for 3 months.
Interventions
DIETARY_SUPPLEMENTFeru-guard
Ferulic acid and Angelica dietary supplement in capsules
OTHERPlacebo
Placebo capsules
Sponsors
Oregon Health and Science University
Glovia Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomized, Double-Blind, Placebo-Controlled Study
Eligibility
Sex/Gender
ALL
Age
65 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* 65 to 89 years old * Not demented or mild cognitive impairment, defined as Clinical Dementia Rating (CDR) =0 and MMSE \>24. * Informant has direct contact with participant at least 2 days per week to verify functional status, CDR, and accompany participant to in-clinic screening visit * Sufficient English language skills to complete all testing.
Exclusion criteria
* Any dementing illness (AD, vascular dementia, normal pressure hydrocephalus, or Parkinson's disease); dementia defined by CDR ≥ 0.50, MMSE \< 25 * AD medication (e.g. acetylcholinesterase inhibitors, NMDA receptor agonist, disease-modifying monoclonal antibody immunotherapy (e.g. lecanemab)) * Significant disease of the CNS such as brain tumor, seizure disorder, subdural hematoma, cranial arteritis * Alcohol or substance abuse according to DSM-IV criteria within the last 2 years * Major depression, schizophrenia, or other major psychiatric disorder defined by DSM-IV criteria * Participants on blood thinners such as warfarin (Coumadin, jantoven), rivaroxaban (xarelto), fondaparinux (arixtra), dibigatran (pradaxa), apixaban (eliquis) dalteparin (fragmin), enoxaparin (lovenox). Aspirin use is allowed. * Participants with malignancy or an acute inflammatory disease. * Participants with critical cardiovascular, circulatory, respiratory, kidney, or liver disease or diabetes * Illness that requires \>1 visit /month to a clinician * BMI of \>30 * Cancer within the last 5 years, with the exception of localized prostate cancer (Gleason Grade \< 3) and non-metastatic skin cancers (melanoma). * Medications: 1. CNS active meds that have not been on stable doses for at least 2 months (cimetidine, beta-blockers, and SSRIs) 2. Neuroleptics, antiparkinsonian agents, systemic corticosteroids, and narcotic analgesics; in the case where these were used for a self-limited time they must have been discounted for a period of five half-lives prior to baseline visit 3. Over the counter supplements are not by themselves exclusionary, however, subjects are asked not to change the dosing regimen over the course of the trial unless medically indicated; the presence and dose of these agents are recorded * Participants who have taken Feru-guard, ferulic acid, or Angelica archangelica supplementation within the last year. * Enrollment in another clinical trial or treatment study within the previous 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti-oxidant Measure | 12 Weeks | general oxidative stress marker malondialdehyde (MDA), |
| general oxidative stress marker malondialdehyde (MDA), | 12 weeks | — |
| Anti-inflammatory measure | 12 weeks | an inflammatory marker tumor necrosis factor alpha (TNF-alpha). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 12 weeks | Adverse Event Report |
Countries
United States
Contacts
CONTACTLynne Shinto, ND, MPH
Outcome results
None listed