UnknownNot Applicable

Equol Supplementation on Blood Pressure and Vascular Function

207 participantsStarted 2015-10

Plain-language 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.

Who can participate

Age range48 Years – 65 Years

SexFEMALE

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Inclusion criteria

✓. Hong Kong Chinese women aged 45-65 y with 2\~8 years menopausal;
✓. 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.
✓. 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).
✓. Written informed consent will be obtained from all the participants prior to enrolment.

Exclusion criteria

✕. Subjects on anti-hypertensive medication or with average SBP≥160 or DBP≥100 or both;
✕. use of medications known to affect BP within past 6 months (hormone therapy, hypoglycemic or weight reduction agents);
✕. 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;
✕. present or history of breast cancer, endometrial cancer, ovarian cancer, thyroid disorder, abnormal uterine bleeding after menopause;
✕. regular smoker or alcohol consumption more than 30 g/day;
✕. known soy allergy.

What they're measuring

Ambulatory blood pressure

Timeframe: 24 weeks

Trial details

NCT IDNCT02515682

SponsorChinese University of Hong Kong

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-07

View on ClinicalTrials.gov More Hypertension trials