Feru-guard and General Antioxidant Capacity in Older People
Feru-guard (Ferulic Acid and Angelica Archangelica Extract) and General Antioxidant Capacity in Older People
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Lynne Shinto, ND, MPH
- Phone Number: (503) 494-5035
- Email: shintol@ohsu.edu
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Oregon Health & Science University
-
Contact:
- Lynne Shinto, ND, MPH
- Phone Number: (503) 494-5035
- Email: shintol@ohsu.edu
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
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:
- CNS active meds that have not been on stable doses for at least 2 months (cimetidine, beta-blockers, and SSRIs)
- 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
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Feru-guard
Feru-guard capsules
|
Ferulic acid and Angelica dietary supplement in capsules
|
|
Placebo Comparator: Placebo Group
Placebo capsules that are matched in size, and color
|
Placebo capsules
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anti-oxidant Measure
Time Frame: 12 Weeks
|
general oxidative stress marker malondialdehyde (MDA),
|
12 Weeks
|
|
general oxidative stress marker malondialdehyde (MDA),
Time Frame: 12 weeks
|
12 weeks
|
|
|
Anti-inflammatory measure
Time Frame: 12 weeks
|
an inflammatory marker tumor necrosis factor alpha (TNF-alpha).
|
12 weeks
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adverse Events
Time Frame: 12 weeks
|
Adverse Event Report
|
12 weeks
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- 17966
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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