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S-equol for Chronic Kidney Disease

Phase 2
Recruiting
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
Women with CKD including stage 3-4 (eGFR 15-59 ml/min/1.73m2) determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) 2021 equation
Postmenopausal (50-69 y) women
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline; 1 hour post ingestion
Awards & highlights

Study Summary

This trial will look into whether equol could improve vascular function and reduce CVD risk in women with CKD.

Who is the study for?
This trial is for postmenopausal women aged 50-69, with or without chronic kidney disease (CKD). Healthy participants need no history of hypertension, CVD, diabetes, or other chronic diseases. Women with CKD must be in stages 3-4 but not on dialysis or have had a kidney transplant. Exclusions include recent hospitalization, certain heart conditions, hormone replacement therapy use within six months, and recent consumption of soy products.Check my eligibility
What is being tested?
The study investigates the immediate effects of S-equol supplement on vascular function in women after one hour of ingestion. It aims to see if this compound can improve blood vessel health due to its anti-inflammatory and antioxidant properties especially in those with CKD where cardiovascular risk is higher.See study design
What are the potential side effects?
While specific side effects are not listed for S-equol supplementation in the provided information, potential side effects may relate to its anti-inflammatory and antioxidant activity which could affect digestive health or cause allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman with moderate to severe kidney disease.
Select...
I am a woman aged 50-69 and have gone through menopause.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline; 1 hour post ingestion
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; 1 hour post ingestion 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
Change in inflammation markers
Change in oxidative stress markers

Side effects data

From 2016 Phase 2 trial • 116 Patients • NCT00962390
3%
Hypersensitivity
3%
Pain in extremity
3%
Dyspnoea
3%
Blood pressure increased
3%
Low density lipoprotein increased
3%
Joint swelling
3%
Dizziness
3%
Depressed mood
3%
Libido decreased
3%
Vision Blurred
3%
Gastro-oesophageal reflux disease
3%
Pyrexia
3%
Paraesthesia of genital male
3%
Prostatomegaly
3%
Prostatic specific antigen increased
3%
Haematuria
3%
Erectile dysfunction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo BID
S-equol 150 mg BID
S-equol 50 mg BID
S-equol 10 mg BID

Trial Design

2Treatment groups
Experimental Treatment
Group I: (1) S-equol, (2) PlaceboExperimental Treatment1 Intervention
Group II: (1) Placebo, (2) S-equolExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
S-equol
2017
Completed Phase 2
~590

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,738 Previous Clinical Trials
2,149,488 Total Patients Enrolled

Frequently Asked Questions

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

What is the total number of participants in this experiment?

"Affirmative, according to the data posted on clinicaltrials.gov this study is still recruiting participants for its trials. Initially published in March 7th 2023 and last edited November 7th 2023, the experiment seeks 38 individuals from a single medical facility."

Answered by AI

Are there any unfilled vacancies in this research trial?

"According to clinicialtrials.gov, this medical experiment is still seeking volunteers. It was first posted on March 7th 2023 and has been edited as recently as November 7th 2023."

Answered by AI

To what degree can S-equol be deemed safe for human consumption?

"Based on the limited clinical data available, our team has gauged S-equol's safety as a 2. This is because this Phase 2 trial does not yet have any evidence demonstrating its efficacy."

Answered by AI

Are elderly individuals eligible to participate in this experiment?

"This clinical trial stipulates that participants should be between 50 and 69 years of age."

Answered by AI

Does my health profile qualify me to partake in this trial?

"The study is limited to 38 participants suffering from chronic kidney disease with ages ranging between 50 and 69."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Acute Equol Supplementation and Vascular Function in Women With and Without CKD
Ester Oh 2023. "Acute Equol Supplementation and Vascular Function in Women With and Without CKD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06128278.
All > Colorado Springs
~17 spots leftby Mar 2025
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