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Trial record 8 of 20 for:    S-equol

Equol Supplementation on Blood Pressure and Vascular Function

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ClinicalTrials.gov Identifier: NCT02515682
Recruitment Status : Not yet recruiting
First Posted : August 5, 2015
Last Update Posted : August 5, 2015
Sponsor:
Information provided by (Responsible Party):
Liu Zhaomin, Chinese University of Hong Kong

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 Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2018

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.




Primary Outcome Measures :
  1. Ambulatory blood pressure [ Time Frame: 24 weeks ]


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Ages Eligible for Study:   48 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Liu Zhaomin, Research Assistant Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT02515682     History of Changes
Other Study ID Numbers: 471213
CRE-2013.119-T ( Other Identifier: Ethics Committee of the Chinese University of Hong Kong )
First Posted: August 5, 2015    Key Record Dates
Last Update Posted: August 5, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Equol
Phytoestrogens
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs