Back to resultsEquol Supplementation on Blood Pressure and Vascular Function
Primary Purpose
Hypertension
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High equol group
Low equol group
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Hypertension
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
High equol
Low equol
Placebo
Arm Description
High equol group will be given natural S-equol supplementation 20mg per day for 24 week.
Low equol group will be given natural S-equol supplementation 10mg/d (+10mg starch) for 24 weeks
Placebo group will be given placebo control (made from starch) 20 mg per day for 24 weeks.
Outcomes
Primary Outcome Measures
Ambulatory blood pressure
Secondary Outcome Measures
Full Information
NCT ID
NCT02515682
First Posted
July 31, 2015
Last Updated
August 3, 2015
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT02515682
Brief Title
Equol Supplementation on Blood Pressure and Vascular Function
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 Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
207 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High equol
Arm Type
Active Comparator
Arm Description
High equol group will be given natural S-equol supplementation 20mg per day for 24 week.
Arm Title
Low equol
Arm Type
Active Comparator
Arm Description
Low equol group will be given natural S-equol supplementation 10mg/d (+10mg starch) for 24 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo group will be given placebo control (made from starch) 20 mg per day for 24 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
High equol group
Intervention Description
Participants will be give natural S-equol 20mg/d for 24 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Low equol group
Intervention Description
Participants will be give natural S-equol 10mg/d for 24 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Participants will be give placebo for 24 weeks.
Primary Outcome Measure Information:
Title
Ambulatory blood pressure
Time Frame
24 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
48 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
12. IPD Sharing Statement
Citations:
PubMed Identifier
26928904
Citation
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.
Results Reference
derived
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Equol Supplementation on Blood Pressure and Vascular Function
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