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Short-chain fatty acid

Acetate Supplements for Age-Related Vascular Stiffness

Phase 2
Recruiting
Led By Vienna Brunt, PhD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 50+ years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

This trialwill test if supplementing with acetate can reduce risk of cardiovascular diseases in adults over 50.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include digestive discomfort due to the supplements and possible changes in blood mineral levels. The safety profile will be closely monitored given that participants are older adults.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 50 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Brachial Artery Flow-Mediated Dilation
Secondary outcome measures
Change in Carotid-Femoral Pulse Wave Velocity (CFPWV)
Change in Casual (seated, resting) systolic blood pressure
Other outcome measures
% of prescribed amount of drug that is consumed
Change in 24-hour ambulatory blood pressure
Change in Endothelial Cell Markers of Oxidative Stress
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AcetateExperimental Treatment1 Intervention
Subjects will be orally supplemented with calcium acetate for 12 weeks. Subjects will be instructed to take a volume of the oral liquid solution that contains 1,334 mg of calcium acetate 3x per day with meals, for a total dose of 4,000 mg/day. Calcium acetate will be compounded by the CU Anschutz Medical Campus Research Pharmacy and dispensed to subjects in 4-week supplies.
Group II: PlaceboPlacebo Group1 Intervention
Subjects will be orally supplemented with calcium carbonate for 12 weeks. This placebo has been selected to match any potential effects of calcium and phosphate binding of the calcium acetate, i.e., we will isolate the effects of acetate. Subjects will be instructed to take a volume of the oral liquid solution equal to that of the calcium acetate group 3x per day with meals. To match the amount of elemental calcium between calcium acetate and calcium carbonate, this dose of calcium carbonate will contain 833 mg of calcium carbonate, for a total dose of 2,500 mg/day. Calcium carbonate will be compounded by the CU Anschutz Medical Campus Research Pharmacy, visually identical to calcium acetate including the packaging, and dispensed to subjects in 4-week supplies.

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,736 Previous Clinical Trials
2,149,129 Total Patients Enrolled
19 Trials studying Aging
4,284 Patients Enrolled for Aging
Vienna Brunt, PhDPrincipal InvestigatorUniversity of Colorado - Anschutz Medical Campus

Media Library

Acetate (Short-chain fatty acid) Clinical Trial Eligibility Overview. Trial Name: NCT05424263 — Phase 2
Aging Research Study Groups: Placebo, Acetate
Aging Clinical Trial 2023: Acetate Highlights & Side Effects. Trial Name: NCT05424263 — Phase 2
Acetate (Short-chain fatty acid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05424263 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants being accepted into the trial at this time?

"The correct answer is that this clinical trial, which was posted on September 29th 2020 and edited on October 10th 2020, is currently looking for 66 patients from 1 location. The information can be found on clinicaltrials.gov"

Answered by AI

Is the use of Acetate regulated by the FDA?

"Acetate's safety is rated as a 2 because, although there is some evidence backing its safety, no clinical data has been collected to support efficacy."

Answered by AI

What is the total number of people who have signed up for this clinical trial?

"Yes, this is an ongoing clinical trial that was originally posted on September 29th, 2022. The study's purpose is to enroll 66 participants at a single site."

Answered by AI

Who else is applying?

What state do they live in?
Colorado
What site did they apply to?
University of Colorado Anschutz Medical Campus
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Acetate and Age-associated Arterial Dysfunction
2022. "Acetate and Age-associated Arterial Dysfunction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05424263.
~28 spots leftby Jul 2025
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