ID

36152

Beschreibung

Equol Supplementation on Blood Pressure and Vascular Function; ODM derived from: https://clinicaltrials.gov/show/NCT02515682

Link

https://clinicaltrials.gov/show/NCT02515682

Stichworte

Versionen (1)
  1. 18.04.19 18.04.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

18. April 2019

DOI

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Creative Commons BY 4.0
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Eligibility Hypertension NCT02515682

Englisch

Eligibility Hypertension NCT02515682

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. hong kong chinese women aged 45-65 y with 2~8 years menopausal;
Beschreibung

Gender Chinese | Age | Menopausal state Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0152035
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C0025320
UMLS CUI [3,2]
C0449238
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.
Beschreibung

Systolic Pressure mean | Diastolic blood pressure mean | Blood pressure determination Quantity Sphygmomanometer

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0444504
UMLS CUI [2,1]
C0428883
UMLS CUI [2,2]
C0444504
UMLS CUI [3,1]
C0005824
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0183427
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).
Beschreibung

24 Hour Urine Test | Equol Daidzein Ratio | Daidzein U/day

Datentyp

boolean

Alias
UMLS CUI [1]
C1255149
UMLS CUI [2,1]
C0059497
UMLS CUI [2,2]
C0057090
UMLS CUI [2,3]
C0456603
UMLS CUI [3,1]
C0057090
UMLS CUI [3,2]
C0456683
4. written informed consent will be obtained from all the participants prior to enrolment.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. subjects on anti-hypertensive medication or with average sbp≥160 or dbp≥100 or both;
Beschreibung

Antihypertensive Agents | Average systolic blood pressure | Average diastolic blood pressure

Datentyp

boolean

Alias
UMLS CUI [1]
C0003364
UMLS CUI [2]
C1282151
UMLS CUI [3]
C1282163
2. use of medications known to affect bp within past 6 months (hormone therapy, hypoglycemic or weight reduction agents);
Beschreibung

Pharmaceutical Preparations Affecting Blood Pressure | Hormone Therapy | Hypoglycemic Agents | Weight-Loss Agents

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0005823
UMLS CUI [2]
C0279025
UMLS CUI [3]
C0020616
UMLS CUI [4]
C0376606
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;
Beschreibung

Chronic disease Affecting Blood Pressure | Chronic disease Limiting Study Subject Participation Status | Cerebrovascular accident | Myocardial Infarction | Liver disease Severe | Kidney Disease Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0005823
UMLS CUI [2,1]
C0008679
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C2348568
UMLS CUI [3]
C0038454
UMLS CUI [4]
C0027051
UMLS CUI [5,1]
C0023895
UMLS CUI [5,2]
C0205082
UMLS CUI [6,1]
C0022658
UMLS CUI [6,2]
C0205082
4. present or history of breast cancer, endometrial cancer, ovarian cancer, thyroid disorder, abnormal uterine bleeding after menopause;
Beschreibung

Breast Carcinoma | Endometrial Carcinoma | Ovarian Carcinoma | Thyroid Disease | Abnormal uterine bleeding Postmenopausal

Datentyp

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2]
C0476089
UMLS CUI [3]
C0029925
UMLS CUI [4]
C0040128
UMLS CUI [5,1]
C3650625
UMLS CUI [5,2]
C0232970
5. regular smoker or alcohol consumption more than 30 g/day;
Beschreibung

Tobacco use Regular | Alcohol consumption g/day

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0205272
UMLS CUI [2,1]
C0001948
UMLS CUI [2,2]
C0439417
6. known soy allergy.
Beschreibung

Allergy to soy

Datentyp

boolean

Alias
UMLS CUI [1]
C4075590
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Ähnliche Modelle

Eligibility Hypertension NCT02515682

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender Chinese | Age | Menopausal state Duration
Item
1. hong kong chinese women aged 45-65 y with 2~8 years menopausal;
boolean
C0079399 (UMLS CUI [1,1])
C0152035 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
C0025320 (UMLS CUI [3,1])
C0449238 (UMLS CUI [3,2])
Systolic Pressure mean | Diastolic blood pressure mean | Blood pressure determination Quantity Sphygmomanometer
Item
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.
boolean
C0871470 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C0428883 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C0005824 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0183427 (UMLS CUI [3,3])
24 Hour Urine Test | Equol Daidzein Ratio | Daidzein U/day
Item
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).
boolean
C1255149 (UMLS CUI [1])
C0059497 (UMLS CUI [2,1])
C0057090 (UMLS CUI [2,2])
C0456603 (UMLS CUI [2,3])
C0057090 (UMLS CUI [3,1])
C0456683 (UMLS CUI [3,2])
Informed Consent
Item
4. written informed consent will be obtained from all the participants prior to enrolment.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Antihypertensive Agents | Average systolic blood pressure | Average diastolic blood pressure
Item
1. subjects on anti-hypertensive medication or with average sbp≥160 or dbp≥100 or both;
boolean
C0003364 (UMLS CUI [1])
C1282151 (UMLS CUI [2])
C1282163 (UMLS CUI [3])
Pharmaceutical Preparations Affecting Blood Pressure | Hormone Therapy | Hypoglycemic Agents | Weight-Loss Agents
Item
2. use of medications known to affect bp within past 6 months (hormone therapy, hypoglycemic or weight reduction agents);
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0005823 (UMLS CUI [1,3])
C0279025 (UMLS CUI [2])
C0020616 (UMLS CUI [3])
C0376606 (UMLS CUI [4])
Chronic disease Affecting Blood Pressure | Chronic disease Limiting Study Subject Participation Status | Cerebrovascular accident | Myocardial Infarction | Liver disease Severe | Kidney Disease Severe
Item
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;
boolean
C0008679 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0005823 (UMLS CUI [1,3])
C0008679 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0038454 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0023895 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0022658 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
Breast Carcinoma | Endometrial Carcinoma | Ovarian Carcinoma | Thyroid Disease | Abnormal uterine bleeding Postmenopausal
Item
4. present or history of breast cancer, endometrial cancer, ovarian cancer, thyroid disorder, abnormal uterine bleeding after menopause;
boolean
C0678222 (UMLS CUI [1])
C0476089 (UMLS CUI [2])
C0029925 (UMLS CUI [3])
C0040128 (UMLS CUI [4])
C3650625 (UMLS CUI [5,1])
C0232970 (UMLS CUI [5,2])
Tobacco use Regular | Alcohol consumption g/day
Item
5. regular smoker or alcohol consumption more than 30 g/day;
boolean
C0543414 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0001948 (UMLS CUI [2,1])
C0439417 (UMLS CUI [2,2])
Allergy to soy
Item
6. known soy allergy.
boolean
C4075590 (UMLS CUI [1])
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