Vascular Aging and Lp299v Study in Healthy Adults

Running, not enrolling · Not applicable · Has a placebo group

Conditions studied: Vascular Aging

In brief

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.

Key facts

Study ID

NCT05296395

Run by

Medical College of Wisconsin

People needed

20

Starts

2023-02-01

Expected to finish

2027-09-22

Last updated by the study team

2026-05-01

Who can join

Age: 50 and older, up to 99. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Ages 50-99 years
• For women: 12 months or more since last menstruation

You may not qualify if…

• 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

Where it is running

• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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