Vascular Aging and Lp299v Study in Healthy Adults

April 27, 2026 updated by: Michael E. Widlansky, Medical College of Wisconsin

Impact of Lp299v on Vascular Aging in Healthy Adults

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Multiple lines of evidence suggest that aging results in significant changes in the composition and metabolism of the gut microbiota that accelerate mechanisms responsible for vascular aging. Recent work established cross-sectional associations between phenotypically older vasculature (with increased vascular stiffness and impaired brachial endothelium-dependent vasodilation) and age-related alterations on the composition of the gut microbiota and metabolites that are derived from microbial metabolism such as TMAO (trimethylamine-N-oxide), nicotinamide, tryptophan, and purines. Animal data also suggests short-chain fatty acids favorably impact endothelium-dependent vasodilation. SCFAs exert a direct anti-inflammatory effect on mononuclear cells and increase glucagon-like protein 1 (GLP-1) production which activates endothelial nitric oxide synthase (eNOS) and increases NO levels. Taken together, these data suggest aging-related changes in the gut microbiota could adversely affect vascular health through multiple mechanisms, even in the absence of concomitant cardiovascular risk factors.

Six weeks of Lp299v supplementation in 36 otherwise healthy smokers reduced systemic inflammation, as evidenced by reductions in leptin (an adipokine that stimulates IL-6 production) and IL-6 levels, reduced monocyte adhesion to endothelial cells, and reduced circulating fibrinogen levels (elevated in the setting of inflammation). In addition, Lp299v supplementation reduced oxidative stress based on reduced urinary F2-isoprostanes and had a modest lowering effect on systolic blood pressure.

The investigators will recruit 20 healthy older adults (10 men, 10 women ages 50 or older) without traditional cardiac risk factors or prevalent cardiovascular disease and randomize subjects into a 6-week, double-blind, randomized, placebo-controlled clinical trial of Lp299v supplementation. Measurements of micro-and macrovascular function, systemic inflammation, and stool microbiota composition will be made.

Study Type

Interventional

Enrollment (Estimated)

20

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 Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

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

50 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

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: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lp299v
Subjects will consume 20 billion colony forming units of Lp299v (1 serving of GoodBelly fermented oat drink) once daily for 6 weeks
Other: Lactobacillus Plantarum 299v in fermented oat drink
The intervention is a probiotic lactobacillus that is contained in food products in the US
Other Names:
  • GoodBelly StraighShot
Placebo Comparator: Heat-killed placebo control
Subjects will consume 1 serving of GoodBelly fermented oat drink that has been treated to heat kill all Lp299v once daily for 6 weeks
Other: Heat-Killed Placebo control fermented drink
The intervention is the GoodBelly StraightShort that has been treated to heat kill all Lp299v

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brachial Artery Flow Mediated Dilation (FMD%
Time Frame: 6 weeks
This is a measurement of endothelial function in the brachial artery
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nitroglycerin-Mediated Vasodilation of the brachial artery (NMD)
Time Frame: 6 weeks
Measurement of vascular smooth muscle reactivity
6 weeks
Hyperemic Flow Velocity
Time Frame: 6 weeks
Measurement of microvascular endothelial function
6 weeks
Carotid-Femoral Pulse Wave Velocity (cfPWV)
Time Frame: 6 weeks
Measurement of vascular stiffness
6 weeks
Stool microbiota alpha diversity
Time Frame: 6 weeks
Diversity of bacterial species in the individual microbiome
6 weeks
Stool microbiota beta diversity
Time Frame: 6 weeks
Differences in bacterial composition between intervention arms
6 weeks
Brachial Artery Resting Diameter
Time Frame: 6 weeks
resting diameter of the brachial artery - representative of resting vascular tone
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College of Wisconsin

Investigators

  • Principal Investigator: Michael E Widlansky, MD, Medical College of Wisconsin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

February 1, 2023

Primary Completion (Estimated)

September 22, 2026

Study Completion (Estimated)

September 22, 2027

Study Registration Dates

First Submitted

March 15, 2022

First Submitted That Met QC Criteria

March 24, 2022

First Posted (Actual)

March 25, 2022

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PRO43157

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All data that are relevant to publication of the results of this work

IPD Sharing Time Frame

Within 1 year of completion of publication of study.

IPD Sharing Access Criteria

Data will be available to qualified investigators.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

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.

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