ID

39908

Description

A Human Trial to Assess the Low Density Lipoprotein Cholesterol (LDL-C) Lowering Effect of Soy; ODM derived from: https://clinicaltrials.gov/show/NCT01547585

Link

https://clinicaltrials.gov/show/NCT01547585

Keywords

Versions (1)
  1. 3/3/20 3/3/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 3, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypercholesterolemia NCT01547585

English

Eligibility Hypercholesterolemia NCT01547585

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
males and females (not pregnant or lactating) aged 30-70 year
Description

Age | Pregnancy Absent | Breast Feeding Absent

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0006147
UMLS CUI [3,2]
C0332197
body mass index (bmi) ≤40kg/m² and ≥18.5kg/m²
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
fasting plasma total cholesterol ≥5.0
Description

Plasma total cholesterol level Fasting

Data type

boolean

Alias
UMLS CUI [1,1]
C1272107
UMLS CUI [1,2]
C0015663
fasting plasma ldl cholesterol ≥3.0 and <5.0 mmol/l.
Description

Plasma fasting LDL cholesterol measurement

Data type

boolean

Alias
UMLS CUI [1]
C0583328
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
fasting plasma triglycerides ≥4.0 mmol/l
Description

Plasma fasting triglyceride measurement

Data type

boolean

Alias
UMLS CUI [1]
C0583331
abnormal liver and kidney function
Description

Liver Dysfunction | Abnormal renal function

Data type

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0151746
unstable body weight(>3kg change in 3 months) or intention to lose or gain weight;
Description

Body Weight Unstable | Wants to lose weight | Intention Weight Gain

Data type

boolean

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C0443343
UMLS CUI [2]
C0421273
UMLS CUI [3,1]
C1283828
UMLS CUI [3,2]
C0043094
diabetes mellitus (fasting plasma glucose ≥7.0 mmol/l or use of insulin or any hypoglycemic or anti-hyperglycemic medication);
Description

Diabetes Mellitus | Plasma fasting glucose measurement | Insulin use | Hypoglycemic Agents

Data type

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0583513
UMLS CUI [3]
C0240016
UMLS CUI [4]
C0020616
use of any prescription or non-prescription drug, prebiotics or probiotics, herbal or nutritional supplement known to affect blood lipids, except for stable doses (no change in 3 months) of thyroxine, oral contraceptive agents, hormone replacement therapy, and medications for controlling blood pressure);
Description

Medication use | Drugs, Non-Prescription | Prebiotics | Probiotics | Herbal Supplements Affecting Blood lipids | Dietary Supplements Affecting Blood lipids | Exception Thyroxine Dose Stable | Exception Oral Contraceptives | Exception Hormone replacement therapy | Exception Pharmaceutical Preparations Control of blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0240320
UMLS CUI [2]
C0013231
UMLS CUI [3]
C2717875
UMLS CUI [4]
C0525033
UMLS CUI [5,1]
C1504473
UMLS CUI [5,2]
C0392760
UMLS CUI [5,3]
C0596192
UMLS CUI [6,1]
C0242295
UMLS CUI [6,2]
C0392760
UMLS CUI [6,3]
C0596192
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0040165
UMLS CUI [7,3]
C0178602
UMLS CUI [7,4]
C0205360
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0009905
UMLS CUI [9,1]
C1705847
UMLS CUI [9,2]
C0282402
UMLS CUI [10,1]
C1705847
UMLS CUI [10,2]
C0013227
UMLS CUI [10,3]
C1753303
major surgical or medical events within the past 3 months;
Description

Major surgery Recent | Medical condition Major Recent

Data type

boolean

Alias
UMLS CUI [1,1]
C0679637
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205164
UMLS CUI [2,3]
C0332185
presence of a gastrointestinal disorder or medication that alters the digestion and absorption of nutrients; including antibiotic use within the past 6 weeks.
Description

Gastrointestinal Disease | Pharmaceutical Preparations Changing Digestion Nutrients | Pharmaceutical Preparations Changing Nutrient absorption | Use of Antibiotics

Data type

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C0012238
UMLS CUI [2,4]
C0678695
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0392747
UMLS CUI [3,3]
C1961155
UMLS CUI [4,1]
C1524063
UMLS CUI [4,2]
C0003232
consumption of a diet containing ≥15% of energy from saturated fat;
Description

Diet high in saturated fats

Data type

boolean

Alias
UMLS CUI [1]
C0425441
any food allergy or aversion or unwillingness to eat wheat, soy or milk;
Description

Food Allergy | Aversion Wheat | Aversion Soy | Aversion Milk

Data type

boolean

Alias
UMLS CUI [1]
C0016470
UMLS CUI [2,1]
C0233496
UMLS CUI [2,2]
C0043137
UMLS CUI [3,1]
C0233496
UMLS CUI [3,2]
C0037733
UMLS CUI [4,1]
C0233496
UMLS CUI [4,2]
C2825079
consumption of ≥5 servings per week of soy based food products;
Description

Soy bean product Serving U/week

Data type

boolean

Alias
UMLS CUI [1,1]
C1532456
UMLS CUI [1,2]
C1519269
UMLS CUI [1,3]
C0560588
consumption of an average of >2 alcoholic beverages per day;
Description

Consumption Alcoholic Beverages U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0001967
UMLS CUI [1,3]
C0456683
regular smokers (smoking ≥1 cigarette per day) of cigarettes or cigars
Description

Tobacco use Regular

Data type

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0205272
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Similar models

Eligibility Hypercholesterolemia NCT01547585

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Pregnancy Absent | Breast Feeding Absent
Item
males and females (not pregnant or lactating) aged 30-70 year
boolean
C0001779 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Body mass index
Item
body mass index (bmi) ≤40kg/m² and ≥18.5kg/m²
boolean
C1305855 (UMLS CUI [1])
Plasma total cholesterol level Fasting
Item
fasting plasma total cholesterol ≥5.0
boolean
C1272107 (UMLS CUI [1,1])
C0015663 (UMLS CUI [1,2])
Plasma fasting LDL cholesterol measurement
Item
fasting plasma ldl cholesterol ≥3.0 and <5.0 mmol/l.
boolean
C0583328 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Plasma fasting triglyceride measurement
Item
fasting plasma triglycerides ≥4.0 mmol/l
boolean
C0583331 (UMLS CUI [1])
Liver Dysfunction | Abnormal renal function
Item
abnormal liver and kidney function
boolean
C0086565 (UMLS CUI [1])
C0151746 (UMLS CUI [2])
Body Weight Unstable | Wants to lose weight | Intention Weight Gain
Item
unstable body weight(>3kg change in 3 months) or intention to lose or gain weight;
boolean
C0005910 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0421273 (UMLS CUI [2])
C1283828 (UMLS CUI [3,1])
C0043094 (UMLS CUI [3,2])
Diabetes Mellitus | Plasma fasting glucose measurement | Insulin use | Hypoglycemic Agents
Item
diabetes mellitus (fasting plasma glucose ≥7.0 mmol/l or use of insulin or any hypoglycemic or anti-hyperglycemic medication);
boolean
C0011849 (UMLS CUI [1])
C0583513 (UMLS CUI [2])
C0240016 (UMLS CUI [3])
C0020616 (UMLS CUI [4])
Medication use | Drugs, Non-Prescription | Prebiotics | Probiotics | Herbal Supplements Affecting Blood lipids | Dietary Supplements Affecting Blood lipids | Exception Thyroxine Dose Stable | Exception Oral Contraceptives | Exception Hormone replacement therapy | Exception Pharmaceutical Preparations Control of blood pressure
Item
use of any prescription or non-prescription drug, prebiotics or probiotics, herbal or nutritional supplement known to affect blood lipids, except for stable doses (no change in 3 months) of thyroxine, oral contraceptive agents, hormone replacement therapy, and medications for controlling blood pressure);
boolean
C0240320 (UMLS CUI [1])
C0013231 (UMLS CUI [2])
C2717875 (UMLS CUI [3])
C0525033 (UMLS CUI [4])
C1504473 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C0596192 (UMLS CUI [5,3])
C0242295 (UMLS CUI [6,1])
C0392760 (UMLS CUI [6,2])
C0596192 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C0040165 (UMLS CUI [7,2])
C0178602 (UMLS CUI [7,3])
C0205360 (UMLS CUI [7,4])
C1705847 (UMLS CUI [8,1])
C0009905 (UMLS CUI [8,2])
C1705847 (UMLS CUI [9,1])
C0282402 (UMLS CUI [9,2])
C1705847 (UMLS CUI [10,1])
C0013227 (UMLS CUI [10,2])
C1753303 (UMLS CUI [10,3])
Major surgery Recent | Medical condition Major Recent
Item
major surgical or medical events within the past 3 months;
boolean
C0679637 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
Gastrointestinal Disease | Pharmaceutical Preparations Changing Digestion Nutrients | Pharmaceutical Preparations Changing Nutrient absorption | Use of Antibiotics
Item
presence of a gastrointestinal disorder or medication that alters the digestion and absorption of nutrients; including antibiotic use within the past 6 weeks.
boolean
C0017178 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0012238 (UMLS CUI [2,3])
C0678695 (UMLS CUI [2,4])
C0013227 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
C1961155 (UMLS CUI [3,3])
C1524063 (UMLS CUI [4,1])
C0003232 (UMLS CUI [4,2])
Diet high in saturated fats
Item
consumption of a diet containing ≥15% of energy from saturated fat;
boolean
C0425441 (UMLS CUI [1])
Food Allergy | Aversion Wheat | Aversion Soy | Aversion Milk
Item
any food allergy or aversion or unwillingness to eat wheat, soy or milk;
boolean
C0016470 (UMLS CUI [1])
C0233496 (UMLS CUI [2,1])
C0043137 (UMLS CUI [2,2])
C0233496 (UMLS CUI [3,1])
C0037733 (UMLS CUI [3,2])
C0233496 (UMLS CUI [4,1])
C2825079 (UMLS CUI [4,2])
Soy bean product Serving U/week
Item
consumption of ≥5 servings per week of soy based food products;
boolean
C1532456 (UMLS CUI [1,1])
C1519269 (UMLS CUI [1,2])
C0560588 (UMLS CUI [1,3])
Consumption Alcoholic Beverages U/day
Item
consumption of an average of >2 alcoholic beverages per day;
boolean
C0001948 (UMLS CUI [1,1])
C0001967 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
Tobacco use Regular
Item
regular smokers (smoking ≥1 cigarette per day) of cigarettes or cigars
boolean
C0543414 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
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