Effects of acetate on arterial function in older adults
The Short-chain Fatty Acid Acetate for Improving Age-associated Arterial Dysfunction
This study is testing if taking acetate supplements can help improve blood vessel health in older adults aged 50 and up.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT05424263 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of oral acetate supplementation on arterial function in late middle-aged and older adults aged 50 and above. It employs a randomized, double-blind, placebo-controlled design over a 12-week period, measuring primary outcomes such as brachial artery flow-mediated dilation and secondary outcomes like carotid-femoral pulse wave velocity. Participants will receive either calcium acetate or a placebo while their arterial health is monitored through various assessments. The study aims to determine if acetate can improve endothelial function and reduce arterial stiffness, addressing age-related cardiovascular risks.
Who should consider this trial
Good fit: Ideal candidates are adults aged 50 and older with low habitual dietary fiber intake and specific serum phosphorus levels.
Not a fit: Patients with serious chronic diseases or those currently taking calcium supplements may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a novel intervention that improves arterial function and reduces cardiovascular disease risk in older adults.
How similar studies have performed: Other studies have shown promising results with dietary interventions aimed at improving cardiovascular health, but the specific use of acetate in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Able to provide informed consent; * Age 50+ years; * 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; * Weight-stable in the 3 months prior to enrollment (self-report); * Willing to abstain from dietary supplements for 48 hours and from alcohol, tobacco, and cannabis products for 24 hours before all visits; Exclusion Criteria: * History of current serious, chronic clinical disease, e.g., cardiovascular disease, diabetes, liver disease, Alzheimer's disease and related dementias, cancer; * Major changes in health in the past 3 months, e.g., hospitalizations, major surgeries, significant changes in medications; * Currently taking calcium acetate or any other calcium supplementation; * Screening FMDba \> 8%; * Body mass index \> 40 kg/m\^2 at screening; * Regular vigorous/aerobic endurance \>4 bouts/week for \>30 min/bout at a workload of \>6 METS; * Any apparent dependence on or abuse of alcohol, tobacco, and cannabis products; * Pregnancy, breast-feeding, or plans to become pregnant during the duration of the study; * 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.
Where this trial is running
Aurora, Colorado
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Vienna Brunt, PhD — University of Colorado, Denver
- Study coordinator: Jill Herch, BS
- Email: jill.herch@cuanschutz.edu
- Phone: 303-724-5839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.