74 Participants NeededMy employer runs this trial

Equol for Chronic Kidney Disease

EO
EA
Overseen ByEmily Andrews
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?

This trial tests whether a supplement called equol can improve blood vessel function and lower heart disease risk in women with chronic kidney disease (CKD). Equol may help by reducing inflammation and oxidative stress. The trial will compare the effects of equol to a placebo (a pill with no active ingredient) over 12 weeks. Postmenopausal women with CKD who have stable kidney function and consume little soy may be suitable for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important findings.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that equol is likely to be safe for humans?

Studies have shown that equol is generally safe as a supplement. Research suggests it may improve blood vessel health, particularly in postmenopausal women with long-term kidney problems. Derived from soy, equol might offer a safer alternative to hormone replacement therapy.

Regarding side effects, equol appears safe for use up to one year. Some individuals might experience mild side effects such as constipation or bloating. The studies available have not reported any serious safety issues. However, caution is advised with supplements, especially for those with kidney problems, as further research is needed to fully understand its safety.12345

Why do researchers think this study treatment might be promising for CKD?

Unlike the standard treatments for chronic kidney disease, which often include medications like ACE inhibitors and angiotensin receptor blockers, Equol is unique because it is derived from a naturally occurring compound. Researchers are excited about Equol because it targets oxidative stress and inflammation, which are key contributors to kidney damage. This new mechanism of action offers a promising alternative to traditional therapies, potentially slowing disease progression and improving kidney function in a novel way.

What evidence suggests that equol might be an effective treatment for chronic kidney disease?

Studies have shown that equol, a compound from soy, may enhance blood vessel function due to its protective and anti-inflammatory properties. Equol is considered a promising food-based supplement for improving blood vessel health, particularly in postmenopausal women. Although specific information about women with chronic kidney disease (CKD) is limited, research suggests equol might still be beneficial. In this trial, participants will receive either equol or a placebo to assess its potential benefits. Researchers hope equol could reduce the risk of heart disease in this group.12678

Are You a Good Fit for This Trial?

This trial is for postmenopausal women aged 50 or older with stage 3 or 4 chronic kidney disease, who have had stable kidney function and weight over the past three months, eat soy foods less than twice a week, and can give informed consent.

Inclusion Criteria

Low habitual intake of soy (soy-related food intake less than 2 times per week assessed by Soy-Specific Food Frequency Questionnaire)
I have stage 3 or 4 chronic kidney disease with stable kidney function.
Ability to provide informed consent
See 3 more

Exclusion Criteria

I have advanced kidney disease and need regular dialysis.
Allergy and/or intolerance to soy or soy-based products
Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin values 2 times upper limit of normal (AST > 234 U/L, ALT > 104 U/L, total bilirubin > 2.6 mg/dL)
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 12 weeks of oral equol supplementation or placebo

12 weeks
6 visits (in-person) at 2-week intervals

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Equol

Trial Overview

The study tests whether taking equol supplements daily for 12 weeks improves blood vessel health in women with CKD compared to a placebo. Participants are randomly assigned to either the equol group or the placebo group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: EquolExperimental 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+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Citations

S-equol for Chronic Kidney Disease

This trial tests whether S-equol, a compound derived from soy, can improve blood vessel function in women with chronic kidney disease (CKD), ...

2.

researchstudies.cuanschutz.edu

researchstudies.cuanschutz.edu/Study/25-0095

Equol for Better Blood Vessel Health in Postmenopausal ...

This study wants to learn how equol, a supplement made from soy, affects blood vessel health in postmenopausal women with chronic kidney disease (CKD). This ...

Effects of soy protein containing isoflavones in patients with ...

Recent studies have demonstrated mixed results on the effects of soy intake in patients with CKD, and this have not been systematically analyzed.

Equol and Vascular Function in Women With Chronic ...

Equol contributes to improvement in vascular function, mediated in part by its anti-oxidative and anti-inflammatory properties.

Preventing chronic kidney disease and maintaining ... - PMC

Management significantly reduced risks of kidney, cardiovascular, and all-cause death outcomes with weekly semaglutide in persons with T2DM and CKD.86,147

Effect of whole soy and purified isoflavone daidzein on ...

The aim of the study was to examine the long-term effect of commonly used whole soy foods (soy flour) and purified daidzein (one major isoflavone and the ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/24877660/

Effect of whole soy and purified isoflavone daidzein on ...

Six-month consumption of whole soy tended to have a modest improvement of renal function in prehypertensive postmenopausal women with lowered renal function.

S-equol

In addition, these reports include evaluation of safety data, from clinical trials if available, and from preclinical models. S-equol.