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Adverse Childhood ExperiencesNCT07073352

ACEs, SIRT1, and Premature Vascular Aging in Humans

A study testing Nicotinamide Riboside in people with Adverse Childhood Experiences and Endothelial Dysfunction, run by University of Wisconsin, Madison at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Adverse childhood experiences (ACEs) are directly related to cardiovascular morbidity and mortality, and impaired vascular endothelial function (VEF) is an independent predictor of future cardiovascular disease (CVD) risk [1, 2]. Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
What is being tested?
Nicotinamide Riboside
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
2 sitesUnited States
Study dates
27 Mar 2025to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 18 - 30 years
  • ACE score of 0 OR ≥4 (Aim 1); ACE score ≥4 (Aim 2)

Who cannot join

  • Resting arterial blood pressure >140/90 mmHg
  • BMI ≥30 kg/m2 and/or weight unstable (>2.27 kg change) last 6 month
  • Cardiovascular, metabolic, or pulmonary disease
  • Cardiovascular or metabolic prescription drug use
  • Vasoactive antidepressant drug use (SSRIs and clonidine)
  • Currently pregnant or breastfeeding
Show all 11Show fewer
  • Heavy alcohol consumption (AUDIT screening)
  • Use of illicit drugs
  • Current tobacco use
  • Regular vigorous (>6 MET s) aerobic exercise (>4 bouts/week, >30 min/bout)
  • Dietary supplementation with antioxidants or habitual use of NSAIDs

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Kylee West contact

603-923-1657

kwest8@wisc.edu

United States2 sites, 1 recruiting
  • Integrative Laboratory of Applied Physiology and Lifestyle Medicine

    Iowa City, Iowa, 52242

    Completed
  • Department of Kinesiology, University of Wisconsin

    Madison, Wisconsin, 53706

    Kylee West, 603-923-1657, kwest8@wisc.edu

    Recruiting

Other trials in United States

About this study

Official title: Adverse Childhood Experiences and Premature Vascular Aging in Humans: The Role of SIRT1

Adverse childhood experiences (ACEs) are directly related to cardiovascular morbidity and mortality, and impaired vascular endothelial function (VEF) is an independent predictor of future cardiovascular disease (CVD) risk [1, 2]. Previous work from our lab (IRB 202010095) and others [3] demonstrates impaired VEF in young adults with prior exposure to ACEs even in the absence of clinical CVD risk factors. Sirtuin 1 (SIRT1) is a class III histone deacetylase (HDAC) that plays a role in regulating vascular homeostasis and reductions in SIRT1 are associated with age-related endothelial dysfunction [4]. We have shown that ACEs-related impairments in VEF are accompanied by reductions in SIRT1 [5]. However, the mechanisms by which ACE exposure promotes VEF remain unknown. The goal of this project is to establish proof of concept that alterations in vascular SIRT1 expression and activity mediate premature vascular aging in individuals with >=4 ACEs compared to those with 0 ACEs and that, because NAD+ is an essential substrate for SIRT1, increasing NAD+ bioavailability will restore VEF in those with >=4 ACEs.

Thus, we will use a robust translational approach coupling in vivo and in vitro measures of endothelial function, inflammation, oxidative stress, and SIRT1 expression and activity in young adults with (n=30-35) versus without (n=30-35) ACE exposure in a cross-sectional study, and during a randomized controlled trial employing a novel 4-week nicotinamide riboside (NR) supplementation approach to increase SIRT1 activity by increasing cellular NAD+ in ACE+ (n=15/group) to accomplish the following specific aims:

Read more
  1. Determine the mechanisms by which ACE exposure alters the regulation of VEF by SIRT1. We hypothesize that compared to those without ACEs (ACE-), ACE+ will have (H1a) elevated endothelial oxidative stress and inflammation, (H1b) accompanied by reduced endothelial SIRT1 expression and increased p66SHC expression and acetylation of p65 and p53, (H1c) in association with lower VEF.
  2. Determine how targeting SIRT1 by increasing NAD+ bioavailability affects VEF in young adults with ACEs. We hypothesize that systemic NR supplementation will (H2a) augment cellular SIRT1 activity and (H2b) improve VEF in ACE+.

[1] Felitti, V.J., Anda, R.F., Nordenberg, D., Williamson, D.F., Spitz, A.M., Edwards, V., Koss, M.P., \& Marks, J.S. (1998). Relationship of childhood abuse and household dysfunction to many of the leading causes of death in adults: The adverse childhood experiences (ace) study. American Journal of Preventive Medicine, 14(4), 245-258. https://doi.org/10.1016/S0749-3797(98)00017-8. [2] Jenkins, N.D.M., \& Robinson, A.T. (2022). How do adverse childhood experiences get under the skin to promote cardiovascular disease? A focus on vascular health. Function (Oxf), 3(4), zqac032. PMC9279110. 10.1093/function/zqac032. [3] Rodriguez-Miguelez, P., Looney, J., Blackburn, M., Thomas, J., Pollock, J.S., \& Harris, R.A. (2022). The link between childhood adversity and cardiovascular disease risk: Role of cerebral and systemic vasculature. Function. 10.1093/function/zqac029. [4] Thompson, A. M., Wagner, R., \& Rzucidlo, E. M. (2014). Age-related loss of SirT1 expression results in dysregulated human vascular smooth muscle cell function. American Journal of Physiology-Heart and Circulatory Physiology, 307(4), H533-H541. [5] Jenkins, N.D.M., Rogers, E.M., Banks, N.F., Tomko, P.M., Sciarrillo, C.M., Emerson, S.R., Taylor, A., \& Teague, T.K. (2021). Childhood psychosocial stress is linked with impaired vascular endothelial function, lower sirt1, and oxidative stress in young adulthood. Am J Physiol Heart Circ Physiol, 321(3), H532-H541. PMC8461842. 10.1152/ajpheart.00123.2021

Being tested
Nicotinamide Riboside, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nicotinamide RibosideDietary supplement

    Participants will consume 1,000 mg of nicotinamide riboside (NR) upon waking and with an evening meal, and complete a daily supplementation log to assist with compliance monitoring. NR is a naturally occurring vitamin B3 derivative readily taken up by cells as a direct NAD+ precursor. Similar NR supplementation protocols are well-tolerated, boost NAD+ concentrations by ~100-140% achieving a steady state within 1-2 weeks, and increase SIRT activity in humans.

  • PlaceboDietary supplement

    Participants will consume 1,000 mg of placebo (microcrystalline cellulose) upon waking and with an evening meal, and complete a daily supplementation log to assist with compliance monitoring.

Study groups in NCT07073352
Study groupRoleWhat they receive
Nicotinamide RibosideExperimental4-weeks of twice daily, oral supplementation (2,000 mg/day) of NR (NIAGEN® , ChromaDEX, Irvine, CA).
Receives: Dietary Supplement: Nicotinamide Riboside
PlaceboPlacebo comparatorParticipants randomized to the control group will consume matched placebo capsules containing microcrystalline cellulose.
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Vascular endothelial function

    Vascular endothelial function will be assayed in vivo using the brachial artery flow mediated dilation technique as the relative increase in brachial artery diameter in response to 5-minutes of forearm ischemia (peak - baseline diameter / baseline diameter * 100).

    Measured: Before (0 Weeks) and after 4-week supplementation period (4 Weeks)

Secondary outcomes (4)
  1. Endothelial SIRT1 Expression

    Total SIRT1 Expression in Primary Endothelial Cells

    Measured: Before (0 Weeks) and after 4-week supplementation period (4 Weeks)

  2. Endothelial SIRT1 Activity

    Ratio of acetylated:total p53 in Primary Endothelial Cells

    Measured: Before (0 Weeks) and after 4-week supplementation period (4 Weeks)

  3. Cellular SIRT1 Activity in PBMCs

    Cellular SIRT1 activity from nuclear proteins in isolated peripheral blood mononuclear cells (ab156065).

    Measured: Before (0 Weeks) and after 4-week supplementation period (4 Weeks)

  4. Cellular NAD+ metabolites

    Semi-targeted high-resolution mass spectrometry will be used to quantify cellular levels of NAD+ and related metabolites, including: nicotinic acid adenine dinucleotide which is a highly sensitive marker of increased NAD+ metabolism via NR supplementation and adenosine diphosphate ribose which is an indicator of NAD+ consuming (SIRT) activity.

    Measured: Before (0 Weeks) and after 4-week supplementation period (4 Weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2025
  2. Study start27 Mar 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07073352
Sponsor's protocol ID
2026-1168
Other IDs
UWMSN | SOE | Kinesiology Oper, Protocol Version 8/3/26
Status last verified
Aug 2026
First submitted
30 Jun 2025
Last updated
19 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Deidentified data will be made publically available within 1 year of study completion. A study protocol paper will be published in 2026. The informed consent form will also be made publicly available at the award end date.

Questions about this trial

What is this clinical trial studying?

A study testing Nicotinamide Riboside in people with Adverse Childhood Experiences and Endothelial Dysfunction, run by University of Wisconsin, Madison at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kylee West (603-923-1657, kwest8@wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vascular endothelial function (time frame: Before (0 Weeks) and after 4-week supplementation period (4 Weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.

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