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Equol Supplementation on Blood Pressure and Vascular Function

Effect of Natural S-equol on Blood Pressure and Vascular funtion-a Six-month Randomized, Double-blind and Placebo-controlled Trial Among Equol Non-producers of Postmenopausal Women With Prehypertension or Untreated Stage 1 Hypertension

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02515682
Enrollment
207
Registered
2015-08-05
Start date
2015-10-31
Completion date
2018-12-31
Last updated
2015-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Brief summary

We propose to perform a 24-week randomized, double-blind a placebo-controlled trial among 207 non-equol producing postmenopausal women with prehypertension to examine the effectiveness of equol (10mg and 20mg/d) on 24h ambulatory blood pressure, vascular function and other cardiovascular risks (lipid profile, glycemic control and inflammatory biomarkers) and explore the optimal dosage of equol.

Detailed description

Inclusion criteria 1. Hong Kong Chinese women aged 45-65 y with 2\ 8 years menopausal; 2. Mean SBP above 130 mmHg or DBP above 80 mmHg or both based on an average of 6 BP readings on two different occasions measured by sphygmomanometer. 3. Equol non-producer is defined as 24-hour urinary log10 S-equol:daidzein ratio less than -1.75 after daidzein challenge (60mg daidzein daily for 7 consecutive days). Exclusion criteria 1. Subjects on anti-hypertensive medication or with average SBP≥160 or DBP≥100 or both; 2. Use of medications known to affect BP within past 6 months; 3. Medical history or presence of certain chronic diseases that could affect BP or limit the individual's ability to participate in the study; 4. Present or history of certain cancers; 5. Regular smoker or alcohol consumption more than 30 g/day; 6. Known soy allergy.

Interventions

DIETARY_SUPPLEMENTHigh equol group

Participants will be give natural S-equol 20mg/d for 24 weeks.

DIETARY_SUPPLEMENTLow equol group

Participants will be give natural S-equol 10mg/d for 24 weeks.

DIETARY_SUPPLEMENTPlacebo

Participants will be give placebo for 24 weeks.

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
48 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

1. Hong Kong Chinese women aged 45-65 y with 2\ 8 years menopausal; 2. mean SBP above 130 mmHg or DBP above 80 mmHg or both based on an average of 6 BP readings on two different occasions measured by sphygmomanometer. 3. Equol non-producer is defined as 24-hour urinary log10 S-equol:daidzein ratio less than -1.75 after daidzein challenge (60mg daidzein daily for 7 consecutive days). 4. Written informed consent will be obtained from all the participants prior to enrolment.

Exclusion criteria

1. Subjects on anti-hypertensive medication or with average SBP≥160 or DBP≥100 or both; 2. use of medications known to affect BP within past 6 months (hormone therapy, hypoglycemic or weight reduction agents); 3. medical history or presence of certain chronic diseases (stroke, cardiac infarction, severe liver and renal disease etc.) that could affect BP or limit the individual's ability to participate in the study; 4. present or history of breast cancer, endometrial cancer, ovarian cancer, thyroid disorder, abnormal uterine bleeding after menopause; 5. regular smoker or alcohol consumption more than 30 g/day; 6. known soy allergy.

Design outcomes

Primary

MeasureTime frame
Ambulatory blood pressure24 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026