Equol Supplementation on Blood Pressure and Vascular Function

The Chinese University of Hong Kong

Status: Unknown

Conditions: Hypertension

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Low equol group; Dietary Supplement: High equol group

Study type: Interventional

Funder types: Other

Identifiers

NCT02515682

471213

CRE-2013.119-T (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 207 estimated patients

Sex: Female

Ages: 48 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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207 participants in 3 patient groups, including a placebo group

High equol

Active Comparator group

Description:

High equol group will be given natural S-equol supplementation 20mg per day for 24 week.

Treatment:

Dietary Supplement: High equol group

Low equol

Active Comparator group

Description:

Low equol group will be given natural S-equol supplementation 10mg/d (+10mg starch) for 24 weeks

Treatment:

Dietary Supplement: Low equol group

Placebo

Placebo Comparator group

Description:

Placebo group will be given placebo control (made from starch) 20 mg per day for 24 weeks.

Treatment:

Dietary Supplement: Placebo