ID

28774

Description

Efficacy of Sterol Enhanced Soy Beverage on Cholesterol Metabolism, Inflammation and Oxidative Status in Humans; ODM derived from: https://clinicaltrials.gov/show/NCT00924391

Link

https://clinicaltrials.gov/show/NCT00924391

Keywords

Versions (1)
  1. 2/3/18 2/3/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 3, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Coronary Heart Disease NCT00924391

English

Eligibility Coronary Heart Disease NCT00924391

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. healthy males and females, aged 19-60 yr, will be screened for determination of fasting circulating ldl-cholesterol and tg levels.
Description

Healthy | Age | Serum LDL cholesterol measurement Circulating Fasting | Triglycerides measurement Circulating Fasting

Data type

boolean

Alias
UMLS CUI [1]
C3898900
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C0428474
UMLS CUI [3,2]
C0175630
UMLS CUI [3,3]
C0015663
UMLS CUI [4,1]
C0202236
UMLS CUI [4,2]
C0175630
UMLS CUI [4,3]
C0015663
2. subjects accepted into the study will have plasma ldl-c 130-200 mg/dl, tg levels below 250 mg/dl.
Description

Plasma LDL cholesterol measurement | Triglycerides measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278149
UMLS CUI [2]
C0202236
3. the inclusion for body mass index (bmi) range will be 22 to 32 kg/m2.
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
4. subjects must also demonstrate an ability to understand dietary procedures and exercise procedures and be judged as compliant and motivated by the investigators.
Description

Comprehension Diet therapy | Comprehension Exercise | Compliance behavior

Data type

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C0012159
UMLS CUI [2,1]
C0162340
UMLS CUI [2,2]
C0015259
UMLS CUI [3]
C1321605
5. subjects will be permitted to take stable doses of thyroid hormone and anti-hypertensive agents, as long as these are continued equivalently throughout the duration of study.
Description

Thyroid Hormone Preparations Dose Stable | Antihypertensive Agents Dose Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0040135
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0205360
UMLS CUI [2,1]
C0003364
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. history of recent (i.e. less than 3 months) or chronic use of oral hypolipidemic therapy, including fish oils, or probucol within the last 6 months.
Description

Hypolipidemic Agents Oral | Hypolipidemic Agents Oral chronic | Fish Oils | Probucol

Data type

boolean

Alias
UMLS CUI [1,1]
C0086440
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C0086440
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C0205191
UMLS CUI [3]
C0016157
UMLS CUI [4]
C0033215
2. history of chronic use of alcohol (> 2 drinks/day), systemic antibodies, corticosteroids, androgens, or phenytoin.
Description

Alcohol consumption chronic Drinks per day | Antibodies Systemic | Adrenal Cortex Hormones | Androgens | Phenytoin

Data type

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C0001967
UMLS CUI [1,4]
C0439505
UMLS CUI [2,1]
C3495458
UMLS CUI [2,2]
C0205373
UMLS CUI [3]
C0001617
UMLS CUI [4]
C0002844
UMLS CUI [5]
C0031507
3. myocardial infarction, coronary artery bypass, or other major surgical procedures within the last six months.
Description

Myocardial Infarction | Coronary Artery Bypass Surgery | Major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0010055
UMLS CUI [3]
C0679637
4. recent onset of angina, congestive heart failure, inflammatory bowel disease, pancreatitis, diabetes, or significant current (ie. onset within past three months) gastrointestinal, renal, pulmonary, hepatic or biliary disease, or cancer (evidence of active lesions, chemotherapy or surgery in the past year).
Description

Angina Pectoris Onset | Congestive heart failure | Inflammatory Bowel Disease | Pancreatitis | Diabetes Mellitus | Gastrointestinal Disease | Kidney Disease | Lung disease | Liver disease | Gall Bladder Disease | Malignant Neoplasms | Lesion | Chemotherapy | Operative Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C0002962
UMLS CUI [1,2]
C0332162
UMLS CUI [2]
C0018802
UMLS CUI [3]
C0021390
UMLS CUI [4]
C0030305
UMLS CUI [5]
C0011849
UMLS CUI [6]
C0017178
UMLS CUI [7]
C0022658
UMLS CUI [8]
C0024115
UMLS CUI [9]
C0023895
UMLS CUI [10]
C0016977
UMLS CUI [11]
C0006826
UMLS CUI [12]
C0221198
UMLS CUI [13]
C0392920
UMLS CUI [14]
C0543467
5. exercise greater than 15 miles/wk or 4,000 kcal/wk.
Description

Exercise Miles Weekly | Exercise kcal Weekly

Data type

boolean

Alias
UMLS CUI [1,1]
C0015259
UMLS CUI [1,2]
C0331865
UMLS CUI [1,3]
C0332174
UMLS CUI [2,1]
C0015259
UMLS CUI [2,2]
C0439259
UMLS CUI [2,3]
C0332174
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Similar models

Eligibility Coronary Heart Disease NCT00924391

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Healthy | Age | Serum LDL cholesterol measurement Circulating Fasting | Triglycerides measurement Circulating Fasting
Item
1. healthy males and females, aged 19-60 yr, will be screened for determination of fasting circulating ldl-cholesterol and tg levels.
boolean
C3898900 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0428474 (UMLS CUI [3,1])
C0175630 (UMLS CUI [3,2])
C0015663 (UMLS CUI [3,3])
C0202236 (UMLS CUI [4,1])
C0175630 (UMLS CUI [4,2])
C0015663 (UMLS CUI [4,3])
Plasma LDL cholesterol measurement | Triglycerides measurement
Item
2. subjects accepted into the study will have plasma ldl-c 130-200 mg/dl, tg levels below 250 mg/dl.
boolean
C1278149 (UMLS CUI [1])
C0202236 (UMLS CUI [2])
Body mass index
Item
3. the inclusion for body mass index (bmi) range will be 22 to 32 kg/m2.
boolean
C1305855 (UMLS CUI [1])
Comprehension Diet therapy | Comprehension Exercise | Compliance behavior
Item
4. subjects must also demonstrate an ability to understand dietary procedures and exercise procedures and be judged as compliant and motivated by the investigators.
boolean
C0162340 (UMLS CUI [1,1])
C0012159 (UMLS CUI [1,2])
C0162340 (UMLS CUI [2,1])
C0015259 (UMLS CUI [2,2])
C1321605 (UMLS CUI [3])
Thyroid Hormone Preparations Dose Stable | Antihypertensive Agents Dose Stable
Item
5. subjects will be permitted to take stable doses of thyroid hormone and anti-hypertensive agents, as long as these are continued equivalently throughout the duration of study.
boolean
C0040135 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
C0003364 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Hypolipidemic Agents Oral | Hypolipidemic Agents Oral chronic | Fish Oils | Probucol
Item
1. history of recent (i.e. less than 3 months) or chronic use of oral hypolipidemic therapy, including fish oils, or probucol within the last 6 months.
boolean
C0086440 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0086440 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0205191 (UMLS CUI [2,3])
C0016157 (UMLS CUI [3])
C0033215 (UMLS CUI [4])
Alcohol consumption chronic Drinks per day | Antibodies Systemic | Adrenal Cortex Hormones | Androgens | Phenytoin
Item
2. history of chronic use of alcohol (> 2 drinks/day), systemic antibodies, corticosteroids, androgens, or phenytoin.
boolean
C0001948 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0001967 (UMLS CUI [1,3])
C0439505 (UMLS CUI [1,4])
C3495458 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0001617 (UMLS CUI [3])
C0002844 (UMLS CUI [4])
C0031507 (UMLS CUI [5])
Myocardial Infarction | Coronary Artery Bypass Surgery | Major surgery
Item
3. myocardial infarction, coronary artery bypass, or other major surgical procedures within the last six months.
boolean
C0027051 (UMLS CUI [1])
C0010055 (UMLS CUI [2])
C0679637 (UMLS CUI [3])
Angina Pectoris Onset | Congestive heart failure | Inflammatory Bowel Disease | Pancreatitis | Diabetes Mellitus | Gastrointestinal Disease | Kidney Disease | Lung disease | Liver disease | Gall Bladder Disease | Malignant Neoplasms | Lesion | Chemotherapy | Operative Surgical Procedures
Item
4. recent onset of angina, congestive heart failure, inflammatory bowel disease, pancreatitis, diabetes, or significant current (ie. onset within past three months) gastrointestinal, renal, pulmonary, hepatic or biliary disease, or cancer (evidence of active lesions, chemotherapy or surgery in the past year).
boolean
C0002962 (UMLS CUI [1,1])
C0332162 (UMLS CUI [1,2])
C0018802 (UMLS CUI [2])
C0021390 (UMLS CUI [3])
C0030305 (UMLS CUI [4])
C0011849 (UMLS CUI [5])
C0017178 (UMLS CUI [6])
C0022658 (UMLS CUI [7])
C0024115 (UMLS CUI [8])
C0023895 (UMLS CUI [9])
C0016977 (UMLS CUI [10])
C0006826 (UMLS CUI [11])
C0221198 (UMLS CUI [12])
C0392920 (UMLS CUI [13])
C0543467 (UMLS CUI [14])
Exercise Miles Weekly | Exercise kcal Weekly
Item
5. exercise greater than 15 miles/wk or 4,000 kcal/wk.
boolean
C0015259 (UMLS CUI [1,1])
C0331865 (UMLS CUI [1,2])
C0332174 (UMLS CUI [1,3])
C0015259 (UMLS CUI [2,1])
C0439259 (UMLS CUI [2,2])
C0332174 (UMLS CUI [2,3])
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