Equol Supplementation on Blood Pressure and Vascular Function

NCT02515682 | Unknown

• 2 other identifiers: 471213CRE-2013.119-T
• Study Type: interventional
• Target: 207
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Ambulatory blood pressure

  24 weeks

Study Arms (3)

High equol

ACTIVE COMPARATOR

High equol group will be given natural S-equol supplementation 20mg per day for 24 week.

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

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.

Dietary Supplement: Placebo

Interventions

High equol group DIETARY_SUPPLEMENT

Participants will be give natural S-equol 20mg/d for 24 weeks.

High equol

Low equol group DIETARY_SUPPLEMENT

Participants will be give natural S-equol 10mg/d for 24 weeks.

Low equol

Placebo DIETARY_SUPPLEMENT

Participants will be give placebo for 24 weeks.

Placebo

Eligibility Criteria

• Age: 48 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Related Publications (1)

• 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.

  PMID: 26928904 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: July 31, 2015
• First Posted: August 5, 2015
• Study Start: October 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: December 1, 2018
• Last Updated: August 5, 2015

Record last verified: 2015-08