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

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.

Study Overview

• Status: Unknown
• Conditions: Hypertension
• Intervention / Treatment: Dietary supplement: High equol group; Dietary supplement: Low equol group; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 207
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

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).
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: High equol; High equol group will be given natural S-equol supplementation 20mg per day for 24 week.	Dietary supplement: High equol group; Participants will be give natural S-equol 20mg/d for 24 weeks.
Active Comparator: Low equol; Low equol group will be given natural S-equol supplementation 10mg/d (+10mg starch) for 24 weeks	Dietary supplement: Low equol group; Participants will be give natural S-equol 10mg/d for 24 weeks.
Placebo Comparator: Placebo; Placebo group will be given placebo control (made from starch) 20 mg per day for 24 weeks.	Dietary supplement: Placebo; Participants will be give placebo for 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ambulatory blood pressure	24 weeks

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Publications and helpful links

General Publications

• Liu ZM, Ho SC, Chen YM, Xie YJ, Huang ZG, Ling WH. Research protocol: effect of natural S-equol on blood pressure and vascular function--a six-month randomized controlled trial among equol non-producers of postmenopausal women with prehypertension or untreated stage 1 hypertension. BMC Complement Altern Med. 2016 Mar 1;16:89. doi: 10.1186/s12906-016-1065-5.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: July 31, 2015
• First Submitted That Met QC Criteria: August 3, 2015
• First Posted (Estimate): August 5, 2015

Study Record Updates

• Last Update Posted (Estimate): August 5, 2015
• Last Update Submitted That Met QC Criteria: August 3, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens, Non-Steroidal; Estrogens; Phytoestrogens; Equol
• Other Study ID Numbers: 471213; CRE-2013.119-T (Other Identifier: Ethics Committee of the Chinese University of Hong Kong)