Equol Supplementation on Blood Pressure and Vascular Function

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02515682
• Other study ID #: 471213
• Secondary ID: CRE-2013.119-T
• Status: Not yet recruiting
• Phase: N/A
• First received: July 31, 2015
• Last updated: August 3, 2015
• Start date: October 2015
• Est. completion date: December 2018

Study information

• Verified date: August 2015
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 207
• Est. completion date: December 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 48 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypertension

Intervention

Dietary Supplement:
• High equol group
Participants will be give natural S-equol 20mg/d for 24 weeks.
• Low equol group
Participants will be give natural S-equol 10mg/d for 24 weeks.
• Placebo
Participants will be give placebo for 24 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ambulatory blood pressure		24 weeks	No