- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07801521
Feru-guard and General Antioxidant Capacity in Older People
September 2, 2026 updated by: Lynne Shinto, ND, MPH, Oregon Health and Science University
Feru-guard (Ferulic Acid and Angelica Archangelica Extract) and General Antioxidant Capacity in Older People
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
No
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / 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
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
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adverse Events
Time Frame: 12 weeks
|
Adverse Event Report
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
November 15, 2026
Primary Completion (Estimated)
April 30, 2028
Study Completion (Estimated)
July 31, 2028
Study Registration Dates
First Submitted
August 31, 2026
First Submitted That Met QC Criteria
September 2, 2026
First Posted (Actual)
September 3, 2026
Study Record Updates
Last Update Posted (Actual)
September 3, 2026
Last Update Submitted That Met QC Criteria
September 2, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 17966
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.