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 range50 Years – 99 Years

SexALL

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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

What they're measuring

Brachial Artery Flow Mediated Dilation (FMD%

Timeframe: 6 weeks

Trial details

NCT IDNCT05296395

SponsorMedical College of Wisconsin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-22