66 Participants Needed

Acetate Supplements for Age-Related Vascular Stiffness

VB
AB
VE
JH
Overseen ByJill Herch, BS
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Colorado, Denver
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

Cardiovascular diseases are the leading cause of morbidity and mortality and contribute most to healthcare costs in the U.S. Age is the strongest cardiovascular disease risk factor, with \>90% of all deaths from cardiovascular disease occurring in adults \>50 years old. The age-associated increased risk of cardiovascular disease is due, in large part, to the development of arterial dysfunction, including endothelial dysfunction and stiffening of the large elastic arteries. Therefore, novel, effective interventions that improve arterial function will have a large public health impact by decreasing the risk of cardiovascular diseases.The short-chain fatty acid acetate is endogenously produced by the gut microbiome from fermentation of dietary soluble fiber. High-fiber diets reduce risk of cardiovascular diseases, but unfortunately, a low percentage of Americans meet guidelines for adequate dietary fiber intake and, despite nationwide efforts to improve this, trends in fiber intake have not improved over the last 20+ years. Thus, directly supplementing acetate may be a more practical and feasible intervention for effectively improving arterial function in older adults and reducing the risk of cardiovascular diseases.The investigators will conduct a study to determine the efficacy of 12 weeks of oral supplementation with acetate for improving arterial function in late middle-aged and older (50+ years) adults. They will also assess the safety and tolerability of acetate supplementation in these adults and perform innovative mechanistic analyses to determine how acetate supplementation improves arterial function. The investigators hypothesize that oral acetate supplementation will improve arterial function by decreasing oxidative stress and increasing nitric oxide bioavailability, and also hypothesize that acetate supplementation will be safe and promote high rates of adherence.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking calcium acetate or any other calcium supplements.

How does the treatment acetate differ from other treatments for age-related vascular stiffness?

Acetate supplements are unique because they may work by providing a source of acetic acid, which could influence metabolic pathways differently than other treatments like sodium nitrite or apigenin that focus on increasing nitric oxide availability or reducing oxidative stress. This approach might offer a novel way to address vascular stiffness by potentially altering metabolic processes rather than directly targeting oxidative stress or nitric oxide pathways.12345

What data supports the effectiveness of the treatment Acetate, Sodium acetate, Acetic acid for age-related vascular stiffness?

While there is no direct evidence for acetate supplements, studies show that sodium nitrite, which also affects nitric oxide levels, can improve vascular function and reduce arterial stiffness in older adults. This suggests that treatments influencing nitric oxide pathways may help with age-related vascular issues.16789

Who Is on the Research Team?

VB

Vienna E Brunt, PhD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for adults aged 50+ with low fiber intake, stable weight, and normal serum phosphorus levels. They must not be pregnant or planning pregnancy, have a BMI over 40, take calcium supplements, or suffer from serious chronic diseases like heart disease or diabetes.

Inclusion Criteria

Serum phosphorus levels >= 2.5 mg/dl at screening
Habitual dietary fiber intake <30 g/day for men or <21 g/day for women, based on Block Fiber Screener conducted at screening
I can avoid dietary supplements for 2 days and alcohol, tobacco, and cannabis for 1 day before visits.
See 3 more

Exclusion Criteria

Your weight is very high for your height, with a body mass index (BMI) over 40.
Any finding on the medical history, physical exam, or standard clinical blood labs that, in the opinion of the physician of record, would put the subject at increased risk with calcium supplementation.
I am currently taking calcium supplements.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive 12 weeks of oral acetate or placebo supplementation to assess arterial function improvement

12 weeks
4 visits (in-person) at weeks 0, 2, 4, and 8; additional phone check-ins at weeks 1, 6, and 10

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks
2 visits (in-person) for post-testing

What Are the Treatments Tested in This Trial?

Interventions

  • Acetate
Trial Overview The study tests if a 12-week oral acetate supplement can improve arterial function in older adults by reducing oxidative stress and increasing nitric oxide. It compares the effects of Calcium Acetate Oral Solution to Calcium Carbonate Oral Suspension.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AcetateExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials
1,842
Recruited
3,028,000+

Published Research Related to This Trial

Oral sodium nitrite supplementation (80 or 160 mg/day) for 10 weeks was found to be safe and well tolerated in middle-aged and older adults, significantly increasing plasma nitrite levels and improving endothelial function by 45-60%.
The treatment also led to improvements in carotid artery elasticity, indicating reduced arterial stiffness, without causing significant changes in blood pressure or adverse effects, suggesting potential benefits for vascular health in aging populations.
Effects of sodium nitrite supplementation on vascular function and related small metabolite signatures in middle-aged and older adults.DeVan, AE., Johnson, LC., Brooks, FA., et al.[2018]
In a pilot study involving 14 men (8 older and 6 young), acute oral ingestion of tetrahydrobiopterin (BH(4)) significantly improved carotid artery compliance and reduced stiffness in older men, suggesting it may help counteract age-related vascular stiffness.
The study found that BH(4) increased its own circulating levels by 17-19 times and also lowered systolic blood pressure in older participants, indicating potential therapeutic benefits for vascular health in aging individuals.
Tetrahydrobiopterin supplementation enhances carotid artery compliance in healthy older men: a pilot study.Pierce, GL., Jablonski, KL., Walker, AE., et al.[2023]
Short-term sodium nitrite therapy significantly reverses age-related vascular endothelial dysfunction and arterial stiffness in older mice, restoring nitric oxide bioavailability and improving blood vessel dilation.
Nitrite treatment also reduces oxidative stress and inflammation markers in older mice, suggesting it could be a promising therapy for addressing arterial aging in humans.
Nitrite supplementation reverses vascular endothelial dysfunction and large elastic artery stiffness with aging.Sindler, AL., Fleenor, BS., Calvert, JW., et al.[2023]

Citations

Effects of sodium nitrite supplementation on vascular function and related small metabolite signatures in middle-aged and older adults. [2018]
Tetrahydrobiopterin supplementation enhances carotid artery compliance in healthy older men: a pilot study. [2023]
Nitrite supplementation reverses vascular endothelial dysfunction and large elastic artery stiffness with aging. [2023]
Oral L-arginine improves endothelial function in healthy individuals older than 70 years. [2022]
Nicotinamide Riboside Supplementation for Treating Elevated Systolic Blood Pressure and Arterial Stiffness in Midlife and Older Adults. [2022]
Apigenin restores endothelial function by ameliorating oxidative stress, reverses aortic stiffening, and mitigates vascular inflammation with aging. [2022]
Age-related changes in the protective effect of chronic administration of L-arginine on post-ischemic recovery of endothelial function. [2019]
Intermittent supplementation with fisetin improves arterial function in old mice by decreasing cellular senescence. [2023]
The Role of Renin-Angiotensin-Aldosterone System and Its New Components in Arterial Stiffness and Vascular Aging. [2018]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security