Vascular Aging and Lp299v Study in Healthy Adults (NCT05296395) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Vascular Aging and Lp299v Study in Healthy Adults
United States20 participantsStarted 2023-02-01
Plain-language summary
Emerging data suggest the gut microbiota regulates multiple mechanisms related to vascular aging, but no intervention targeting the gut microbiota has been tested in older adults without cardiovascular risk factors or cardiovascular disease. Early human data suggest an increase in potentially pathological gut metabolites such as trimethylamine-N-oxide (TMAO) are associated with older age, increased vascular stiffness, increased oxidative stress, and reduced nitric oxide (NO) bioavailability as evidenced by impaired endothelium-dependent vasodilation. Based on this data, the investigators hypothesize that supplementation with Lp299v will reverse human vascular aging in healthy older adults free of known traditional cardiovascular risk factors.
Who can participate
Age range
50 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Ages 50-99 years
* For women: 12 months or more since last menstruation
Exclusion Criteria:
* Systolic Blood Pressure ≥ 130 mmHg or Diastolic BP ≥ 80mmHg
* Currently taking pharmacological therapies for hypertension, dyslipidemia, or glucose control
* Diabetes (type 1 or 2) or glycosylated hemoglobin ≥ 5/7%
* LDL Cholesterol \> 160 mg/dL or Total Cholesterol \> 200 mg/dL
* Cigarette use within 3 years of enrollment
* Average of \> 7500 steps per day as measured during screening period
* Received probiotics, prebiotics, and/or antibiotics within six weeks of enrollment
* History of chronic renal insufficiency, liver dysfunction, or cancer besides non-melanoma skin carcinomas or localized prostate cancer requiring systemic treatment within 3 years of enrollment
* History of inflammatory rheumatic diseases known to increase atherosclerotic cardiovascular risk (e.g. rheumatoid arthritis, systemic lupus erythematosus)
* Known history of cognitive impairment or inability to follow study procedures
* GI tract illnesses such as short gut syndrome, inflammatory bowel disease, or an ileostomy
* Daily alcohol use
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.