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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

Must not have

Currently taking calcium acetate or any other calcium supplementation

Major changes in health in the past 3 months, e.g., hospitalizations, major surgeries, significant changes in medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Approved for 5 Other Conditions

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.

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.

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

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I am 50 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking calcium supplements.

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I haven't had major health changes like hospital stays or big surgeries recently.

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I have a serious chronic condition like heart disease or diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Brachial Artery Flow-Mediated Dilation

Secondary study objectives

Change in Carotid-Femoral Pulse Wave Velocity (CFPWV)

Change in Casual (seated, resting) systolic blood pressure

Other study objectives

% 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

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

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.

0 / 4Eligibility criteria met