NCT07801521尚未招募不适用
Feru-guard (Ferulic Acid and Angelica Archangelica Extract) and General Antioxidant Capacity in Older People
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Anti-oxidant Measure
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 89 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •65 to 89 years old
- •Not demented or mild cognitive impairment, defined as Clinical Dementia Rating (CDR) =0 and MMSE >
- •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.
排除标准
- •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.
研究组 & 干预措施
Feru-guard
Experimental
Feru-guard capsules
干预措施: Feru-guard (Dietary Supplement)
Placebo Group
Placebo Comparator
Placebo capsules that are matched in size, and color
干预措施: Placebo (Other)
结局指标
主要结局
Anti-oxidant Measure
时间窗: 12 Weeks
general oxidative stress marker malondialdehyde (MDA),
general oxidative stress marker malondialdehyde (MDA),
时间窗: 12 weeks
Anti-inflammatory measure
时间窗: 12 weeks
an inflammatory marker tumor necrosis factor alpha (TNF-alpha).
次要结局
- Adverse Events(12 weeks)
研究者
Lynne Shinto, ND, MPH
Professor, Department of Neurology
Oregon Health and Science University
研究点 (1)
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