Could a soy-based supplement boost heart health in women with kidney disease?
NCT ID NCT07194590
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether taking equol, a compound from soy, for 12 weeks can improve blood vessel function in postmenopausal women with moderate chronic kidney disease (stages 3-4). The goal is to lower their high risk of heart disease. Researchers will measure changes in artery flexibility and blood pressure in 74 women aged 50 and older.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 74 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Nov 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Postmenopausal women * Aged ≥50 years * CKD stage 3 or 4 (eGFR with the CKD-EPI 2021 race-free equation: 15-59 mL/min/1.73m2; stable renal function in the past 3 months) * Low habitual intake of soy (soy-related food intake \< 2 times per week assessed by Soy-Specific Food Frequency Questionnaire) * Weight stable in the prior 3 months (\<2 kg weight change) and willing to remain weight stable throughout the study * Ability to provide informed consent. Exclusion Criteria: * Patients with advanced CKD requiring chronic dialysis * Uncontrolled hypertension in CKD group (BP \>140/90 mmHg) * Use of any hormone replacement therapy * Allergy and/or intolerance to soy or soy-based products * Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin values 2X upper limit of normal range (upper limit of normal range AST: 117 U/L; ALT: 52 U/L; total bilirubin: 1.3 mg/dL) * History of breast cancer * Significant co-morbid conditions with a life expectancy of \< 1 year * Current tobacco or nicotine use or history of use in the last 12 months * History of kidney transplant * History of severe congestive heart failure (i.e., ejection fraction \<35%) * History of hospitalization within the last month * Immunosuppressant agents taken in the past 12 months * Known malignancy
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Colorado Anschutz Medical Campus
RECRUITINGAurora, Colorado, 80045, United States
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