Equol Supplementation on Blood Pressure and Vascular Function

Sponsor

Chinese University of Hong Kong (Other)

Overall Status

Unknown status

CT.gov ID

NCT02515682

Collaborator

(none)

207

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Dietary Supplement: High equol group Dietary Supplement: Low equol group Dietary Supplement: Placebo	N/A

Detailed Description

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).

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;
Medical history or presence of certain chronic diseases that could affect BP or limit the individual's ability to participate in the study;
Present or history of certain cancers;
Regular smoker or alcohol consumption more than 30 g/day;
Known soy allergy.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

207 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

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

Study Start Date :

Oct 1, 2015

Anticipated Primary Completion Date :

Jul 1, 2018

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Ambulatory blood pressure [24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

48 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Chinese University of Hong Kong

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Liu Zhaomin, Research Assistant Professor, Chinese University of Hong Kong

ClinicalTrials.gov Identifier:

NCT02515682

Other Study ID Numbers:

471213
CRE-2013.119-T

First Posted:

Aug 5, 2015

Last Update Posted:

Aug 5, 2015

Last Verified:

Aug 1, 2015

Additional relevant MeSH terms:

Hypertension

Equol

Study Results

No Results Posted as of Aug 5, 2015