HypertensionNCT02515682
Equol Supplementation on Blood Pressure and Vascular Function
A study testing High equol group and Low equol group in people with Hypertension, run by Chinese University of Hong Kong.
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… Read more about this study
- Who is it for?
- Ages 48 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- High equol group and Low equol group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 207 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 48 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- High equol group, Low equol group, Placebo
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High equol groupDietary supplement
Participants will be give natural S-equol 20mg/d for 24 weeks.
Low equol groupDietary supplement
Participants will be give natural S-equol 10mg/d for 24 weeks.
PlaceboDietary supplement
Participants will be give placebo for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| High equol | Active comparator | High equol group will be given natural S-equol supplementation 20mg per day for 24 week. Receives: Dietary Supplement: High equol group |
| Low equol | Active comparator | Low equol group will be given natural S-equol supplementation 10mg/d (+10mg starch) for 24 weeks Receives: Dietary Supplement: Low equol group |
| Placebo | Placebo comparator | Placebo group will be given placebo control (made from starch) 20 mg per day for 24 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ambulatory blood pressure
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2015 (estimated)
- Study startOct 2015
- Primary completionJul 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 207 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Zhaomin, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02515682
- Sponsor's protocol ID
- 471213
- Other IDs
- CRE-2013.119-T
- Status last verified
- Aug 2015
- First submitted
- 31 Jul 2015
- Last updated
- 5 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 26928904
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02515682
- Acronym / sponsor ID
- 471213
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 207 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 5 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High equol | Active comparator | Dietary Supplement: High equol groupHigh equol group will be given natural S-equol supplementation 20mg per day for 24 week. |
| Low equol | Active comparator | Dietary Supplement: Low equol groupLow equol group will be given natural S-equol supplementation 10mg/d (+10mg starch) for 24 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo group will be given placebo control (made from starch) 20 mg per day for 24 weeks. |
Who may qualify
- Ages
- 48 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High equol groupParticipants will be give natural S-equol 20mg/d for 24 weeks. | Dietary supplement | High equol |
| Low equol groupParticipants will be give natural S-equol 10mg/d for 24 weeks. | Dietary supplement | Low equol |
| PlaceboParticipants will be give placebo for 24 weeks. | Dietary supplement | Placebo |
Primary outcome
Ambulatory blood pressure
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2015.
- Derived from this study: PubMed 26928904Liu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing High equol group and Low equol group in people with Hypertension, run by Chinese University of Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ambulatory blood pressure (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02515682, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2015.