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Soy supplement shows promise for aging brains and arteries

NCT ID NCT05741060

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This study tests whether a daily soy-based supplement called Equol can slow down stiffening of the arteries, small blood vessel damage in the brain, and memory decline. About 369 older adults (ages 65-85) will take Equol or a placebo for two years. Researchers will measure artery stiffness, brain scans, and thinking tests to see if Equol helps protect brain health.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

369 people

The number who actually took part.

Started

Jun 2023

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

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

65 to 85 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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: Men and women age between 65 and 85 at entry of European Americans or African Americans Inclusion criteria via screening visit: * Individuals who are able to provide informed consent * Individuals who are willing to be randomized to the intervention or placebo group Exclusion Criteria: Exclusion criteria via initial screening by phone * Individuals who are regularly taking isoflavone supplements or eat soy product ≥ 2 times a week (by specific questionnaire) * Individuals who do not agree to maintain isoflavone supplements or soy product intake described above during the study period. * Individuals who have allergy or intolerance to soy isoflavones. * Individuals whose score for the Telephone Interview for Cognitive Status is 22 and below. * Individuals with stroke, neurological disorders, bipolar disease whether or not under medical treatment, cancer treatment in the past 6 months, head trauma or other condition which is not appropriate for the study (e.g., contraindication to magnetic resonance imaging (MRI)). * Individuals with untreated depression * Individuals with atrial fibrillation * Individuals with heart failure * Individuals with heart attack or coronary intervention in the past 6 months * Individuals with carotid endarterectomy or peripheral artery disease * Individuals currently undergoing treatment for pulmonary embolism or deep vein thrombosis * Individuals with aortic (abdominal, thoracic) aneurysm * Individuals with inflammatory bowel diseases * Individuals currently undergoing hemodialysis * Women with a past or family history of breast cancer.\*1 * Women on estrogen replacement therapy * Individuals unable to lay supine for 30-60 minutes * Individuals with weight ≥300 lbs * Individuals who are planning to move out of the area in the next 2 years * Individuals who participated in another clinical trial in the past 3 months Exclusion criteria via screening visit * Individuals with Quick Dementia Rating System (QDRS) score ≥ 6.0 * Individuals who are regularly taking isoflavone supplements or eat soy product ≥ 2 times a week (by specific questionnaire) * Individuals who do not agree to maintain isoflavone supplements or soy product intake described above during the study period. * Individuals who have allergy or intolerance to soy isoflavones. * Blood pressure (BP) - systolic BP ≥ 180 mmHg or diastolic BP ≥ 110 mmHg * Heart rate ≥110 or ≤40 * Hemoglobin \<10 g/dL * HbA1c ≥ 7.5% * Blood creatinine \> 2.0 mg/dL * Liver function tests \> 2 X upper limit of normal * Abnormal thyroid function (Thyroid Stimulating Hormone) * Vitamin B12 levels ≤ 210 pg/mL * Hematocrit \<30% * White blood cell count \<3,000 or \>15,000 * Platelet count \<100,000 or \>600,000 * Urinary protein ≥ + by dipstick * Any condition or therapy which, in the opinion of the investigator, might pose a risk to the participant or make participation in the study not in the participant's best interest In addition, individuals with the following condition will be excluded because these conditions do not allow subjects to undergo examinations the investigators proposed in the project: * Those who are contraindicated for 3 Tesla (3T) structural brain magnetic resonance imaging (MRI) such as pacemakers. * Atrial fibrillation because pulse wave velocity is not accurately measured. * Hearing impairment which interferes with cognitive testing * Vision impairment which interferes with cognitive testing Exclusion criteria at structural brain MRI Any other conditions which, in the opinion of the investigator, might pose a risk to the participant or make participation in the study not in the participant's best interest \*1 Few studies have investigated the association of equol, a metabolite of soy isoflavone daidzein, with breast cancer. These studies reported no significant association of serum or urine equol with the risk of breast cancer. Dietary intake of soy and soy isoflavones is generally considered to have benefits for menopausal symptoms, cardiovascular health, bone health, and cancers of the breast and prostate. Observational studies show that soy consumption is associated with a reduced risk of many cancers including breast cancer. Moreover, a prospective cohort study of 6,000+ North American women with breast cancer showed that dietary intake of soy and isoflavones was associated with reduced all-cause mortality. However, there is little evidence to support that the use of supplements containing soy isoflavones or soy protein powder to reduce cancer risk. A recent large prospective cohort study in France reported that supplementation of soy isoflavones increased the risk of estrogen receptor-negative breast cancer, especially among women who had a history of breast cancer in first-degree relatives. Exclusion criteria at the baseline visit The investigators recruit subjects without dementia. Thus, at the initial screening by phone, the investigators exclude individuals whose score for the Telephone Interview for Cognitive Status is 22 and below. Then, at the screening visit, investigators will exclude individuals with a Quick Dementia Rating System score ≥ 6.0.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease Cognitive Dysfunction dementia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Emory University

    Atlanta, Georgia, 30322, United States

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213, United States

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157, United States

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Other studies related to the condition(s) this trial covers.