ID

36751

Description

Measuring the Impact of Dietary Supplementation With a High Fiber, High Antioxidant Aleurone on Biomarkers of Cardiovascular Disease and Gut Microbiota in Adults With High Body Mass Index; ODM derived from: https://clinicaltrials.gov/show/NCT02067026

Link

https://clinicaltrials.gov/show/NCT02067026

Keywords

Versions (1)
  1. 6/6/19 6/6/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 6, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Overweight NCT02067026

English

Eligibility Overweight NCT02067026

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Overweight NCT02067026
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
bmi between 27 and 33
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
fasting blood glucose >300 mg/dl;
Description

Fasting blood glucose measurement

Data type

boolean

Alias
UMLS CUI [1]
C0428568
triglycerides >500 mg/dl;
Description

Triglycerides measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202236
uncontrolled hypertension (bp >160/100 mm hg under antihypertensive therapy); cardiovascular disease (myocardial infarction, percutaneous transluminal coronary angioplasty or coronary artery bypass grafting, unstable angina pectoris, stoke, peripheral arterial disease);
Description

Uncontrolled hypertension | Blood pressure determination | Antihypertensive therapy | Cardiovascular Disease | Myocardial Infarction | Percutaneous Transluminal Coronary Angioplasty | Coronary Artery Bypass Surgery | Angina, Unstable | Cerebrovascular accident | Peripheral Arterial Disease

Data type

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0005824
UMLS CUI [3]
C0585941
UMLS CUI [4]
C0007222
UMLS CUI [5]
C0027051
UMLS CUI [6]
C2936173
UMLS CUI [7]
C0010055
UMLS CUI [8]
C0002965
UMLS CUI [9]
C0038454
UMLS CUI [10]
C1704436
hypo- or hyperthyroidism;
Description

Hypothyroidism | Hyperthyroidism

Data type

boolean

Alias
UMLS CUI [1]
C0020676
UMLS CUI [2]
C0020550
acute inflammatory diseases;
Description

Inflammatory disorder

Data type

boolean

Alias
UMLS CUI [1]
C1290884
severe gastrointestinal diseases;
Description

Gastrointestinal Diseases Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0205082
heart, liver, renal or pulmonary failure or other life threatening disease with prognosis <5 years;
Description

Heart failure | Liver Failure | Kidney Failure | Pulmonary failure | Life threatening illness | Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C0085605
UMLS CUI [3]
C0035078
UMLS CUI [4]
C0948755
UMLS CUI [5]
C3846017
UMLS CUI [6]
C0023671
chronic use of systemic corticosteroids, anti-coagulants, anti-inflammatory, or lipid lowering and anti-diabetics drugs;
Description

CORTICOSTEROIDS FOR SYSTEMIC USE chronic | Anticoagulants chronic | Anti-Inflammatory Agents chronic | Hypolipidemic Agents chronic | Antidiabetics chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C3653708
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0003280
UMLS CUI [2,2]
C0205191
UMLS CUI [3,1]
C0003209
UMLS CUI [3,2]
C0205191
UMLS CUI [4,1]
C0086440
UMLS CUI [4,2]
C0205191
UMLS CUI [5,1]
C0935929
UMLS CUI [5,2]
C0205191
treatment within the previous 6 weeks with any medication that is known to affect lipoprotein levels or fecal microbiota (specifically, antibiotics);
Description

Pharmaceutical Preparations Affecting Lipoprotein level | Preparation of fecal microbiota | Antibiotics

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0523753
UMLS CUI [2]
C3506808
UMLS CUI [3]
C0003232
food intolerances;
Description

Food intolerance

Data type

boolean

Alias
UMLS CUI [1]
C0149696
alcohol intake >5 drinks per day or use of narcotic substances;
Description

Alcohol consumption Drinks Quantity per day | Narcotics

Data type

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0001967
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0439505
UMLS CUI [2]
C0027415
use of antioxidant vitamin or mineral supplements;
Description

Antioxidant vitamin | Mineral supplements

Data type

boolean

Alias
UMLS CUI [1]
C0556073
UMLS CUI [2]
C0556112
special diet;
Description

On special diet

Data type

boolean

Alias
UMLS CUI [1]
C3164710
pregnancy;
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
smoking.
Description

Tobacco use

Data type

boolean

Alias
UMLS CUI [1]
C0543414
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Similar models

Eligibility Overweight NCT02067026

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Overweight NCT02067026
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Body mass index
Item
bmi between 27 and 33
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Fasting blood glucose measurement
Item
fasting blood glucose >300 mg/dl;
boolean
C0428568 (UMLS CUI [1])
Triglycerides measurement
Item
triglycerides >500 mg/dl;
boolean
C0202236 (UMLS CUI [1])
Uncontrolled hypertension | Blood pressure determination | Antihypertensive therapy | Cardiovascular Disease | Myocardial Infarction | Percutaneous Transluminal Coronary Angioplasty | Coronary Artery Bypass Surgery | Angina, Unstable | Cerebrovascular accident | Peripheral Arterial Disease
Item
uncontrolled hypertension (bp >160/100 mm hg under antihypertensive therapy); cardiovascular disease (myocardial infarction, percutaneous transluminal coronary angioplasty or coronary artery bypass grafting, unstable angina pectoris, stoke, peripheral arterial disease);
boolean
C1868885 (UMLS CUI [1])
C0005824 (UMLS CUI [2])
C0585941 (UMLS CUI [3])
C0007222 (UMLS CUI [4])
C0027051 (UMLS CUI [5])
C2936173 (UMLS CUI [6])
C0010055 (UMLS CUI [7])
C0002965 (UMLS CUI [8])
C0038454 (UMLS CUI [9])
C1704436 (UMLS CUI [10])
Hypothyroidism | Hyperthyroidism
Item
hypo- or hyperthyroidism;
boolean
C0020676 (UMLS CUI [1])
C0020550 (UMLS CUI [2])
Inflammatory disorder
Item
acute inflammatory diseases;
boolean
C1290884 (UMLS CUI [1])
Gastrointestinal Diseases Severe
Item
severe gastrointestinal diseases;
boolean
C0017178 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Heart failure | Liver Failure | Kidney Failure | Pulmonary failure | Life threatening illness | Life Expectancy
Item
heart, liver, renal or pulmonary failure or other life threatening disease with prognosis <5 years;
boolean
C0018801 (UMLS CUI [1])
C0085605 (UMLS CUI [2])
C0035078 (UMLS CUI [3])
C0948755 (UMLS CUI [4])
C3846017 (UMLS CUI [5])
C0023671 (UMLS CUI [6])
CORTICOSTEROIDS FOR SYSTEMIC USE chronic | Anticoagulants chronic | Anti-Inflammatory Agents chronic | Hypolipidemic Agents chronic | Antidiabetics chronic
Item
chronic use of systemic corticosteroids, anti-coagulants, anti-inflammatory, or lipid lowering and anti-diabetics drugs;
boolean
C3653708 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0003280 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0003209 (UMLS CUI [3,1])
C0205191 (UMLS CUI [3,2])
C0086440 (UMLS CUI [4,1])
C0205191 (UMLS CUI [4,2])
C0935929 (UMLS CUI [5,1])
C0205191 (UMLS CUI [5,2])
Pharmaceutical Preparations Affecting Lipoprotein level | Preparation of fecal microbiota | Antibiotics
Item
treatment within the previous 6 weeks with any medication that is known to affect lipoprotein levels or fecal microbiota (specifically, antibiotics);
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0523753 (UMLS CUI [1,3])
C3506808 (UMLS CUI [2])
C0003232 (UMLS CUI [3])
Food intolerance
Item
food intolerances;
boolean
C0149696 (UMLS CUI [1])
Alcohol consumption Drinks Quantity per day | Narcotics
Item
alcohol intake >5 drinks per day or use of narcotic substances;
boolean
C0001948 (UMLS CUI [1,1])
C0001967 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0439505 (UMLS CUI [1,4])
C0027415 (UMLS CUI [2])
Antioxidant vitamin | Mineral supplements
Item
use of antioxidant vitamin or mineral supplements;
boolean
C0556073 (UMLS CUI [1])
C0556112 (UMLS CUI [2])
On special diet
Item
special diet;
boolean
C3164710 (UMLS CUI [1])
Pregnancy
Item
pregnancy;
boolean
C0032961 (UMLS CUI [1])
Tobacco use
Item
smoking.
boolean
C0543414 (UMLS CUI [1])
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