ID

41182

Description

Diet and Systemic Inflammation; ODM derived from: https://clinicaltrials.gov/show/NCT01424306

Link

https://clinicaltrials.gov/show/NCT01424306

Keywords

Versions (1)
  1. 7/6/20 7/6/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 6, 2020

DOI

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License

Creative Commons BY-NC 4.0
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Eligibility Low-grade Chronic Inflammation NCT01424306

English

Eligibility Low-grade Chronic Inflammation NCT01424306

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age: 18-65 years;
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
bmi 20-40 kg/m2;
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
weight stable to within 10 pounds for 6 months prior to entering the study, and at their lifetime maximum weight (or within 30 pounds of it; excluding pregnancy);
Description

Stable body weight

Data type

boolean

Alias
UMLS CUI [1]
C0517386
ability to be admitted for ~30 minutes on three occasions, and ~6 hours on three occasions to the fhcrc prevention center;
Description

Patient Admission Prevention center

Data type

boolean

Alias
UMLS CUI [1,1]
C0030673
UMLS CUI [1,2]
C0199176
UMLS CUI [1,3]
C1552416
ability to provide informed written consent;
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
willingness to consume only food and beverages provided by the human nutrition laboratory of the fhcrc prevention center for three periods of 8 days each.
Description

Food Consumption Specified | Consumption Beverages Specified

Data type

boolean

Alias
UMLS CUI [1,1]
C2983605
UMLS CUI [1,2]
C0205369
UMLS CUI [2,1]
C0009830
UMLS CUI [2,2]
C0005329
UMLS CUI [2,3]
C0205369
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
presence or history of chronic inflammatory, autoimmune or metabolic diseases;
Description

Chronic inflammatory disorder | Autoimmune Diseases | Metabolic Diseases

Data type

boolean

Alias
UMLS CUI [1]
C1290886
UMLS CUI [2]
C0004364
UMLS CUI [3]
C0025517
presence of phenylketonuria, hereditary fructose intolerance, fructose malabsorption, or malabsorption syndromes;
Description

Phenylketonuria | Hereditary fructose intolerance | Fructose Malabsorption | Malabsorption Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0031485
UMLS CUI [2]
C0016751
UMLS CUI [3,1]
C0016745
UMLS CUI [3,2]
C3714745
UMLS CUI [4]
C0024523
abuse of alcohol (>2 drinks per day), smoking, or use of recreational drugs;
Description

Substance Use Disorders | Tobacco use

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0543414
current or recent (within three months) intake of medications likely to interfere with study endpoints (insulin, antidiabetics, β-blockers, anabolic steroids, glucocorticosteroids, daily high-dose non-steroidal anti-inflammatory drugs, warfarin, antibiotics, probiotics);
Description

Pharmaceutical Preparations Interfere with End Point | Insulin | Antidiabetics | Adrenergic beta-1 Receptor Antagonists | Anabolic steroids | Glucocorticoids | NSAIDs High dose Daily | warfarin | Antibiotics | Probiotics

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2349179
UMLS CUI [2]
C0021641
UMLS CUI [3]
C0935929
UMLS CUI [4]
C0304516
UMLS CUI [5]
C0002845
UMLS CUI [6]
C0017710
UMLS CUI [7,1]
C0003211
UMLS CUI [7,2]
C0444956
UMLS CUI [7,3]
C0332173
UMLS CUI [8]
C0043031
UMLS CUI [9]
C0003232
UMLS CUI [10]
C0525033
presence of anemia, recent (within 2 months) history of anemia;
Description

Anemia | History of anemia

Data type

boolean

Alias
UMLS CUI [1]
C0002871
UMLS CUI [2]
C0559154
anyone not willing or able to eat the provided food;
Description

Food Eating Unwilling | Food Eating Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0016452
UMLS CUI [1,2]
C0013470
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C0016452
UMLS CUI [2,2]
C0013470
UMLS CUI [2,3]
C1299582
current or recent (within 12 months) pregnancy or breastfeeding.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Low-grade Chronic Inflammation NCT01424306

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age: 18-65 years;
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
bmi 20-40 kg/m2;
boolean
C1305855 (UMLS CUI [1])
Stable body weight
Item
weight stable to within 10 pounds for 6 months prior to entering the study, and at their lifetime maximum weight (or within 30 pounds of it; excluding pregnancy);
boolean
C0517386 (UMLS CUI [1])
Patient Admission Prevention center
Item
ability to be admitted for ~30 minutes on three occasions, and ~6 hours on three occasions to the fhcrc prevention center;
boolean
C0030673 (UMLS CUI [1,1])
C0199176 (UMLS CUI [1,2])
C1552416 (UMLS CUI [1,3])
Informed Consent
Item
ability to provide informed written consent;
boolean
C0021430 (UMLS CUI [1])
Food Consumption Specified | Consumption Beverages Specified
Item
willingness to consume only food and beverages provided by the human nutrition laboratory of the fhcrc prevention center for three periods of 8 days each.
boolean
C2983605 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0009830 (UMLS CUI [2,1])
C0005329 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Chronic inflammatory disorder | Autoimmune Diseases | Metabolic Diseases
Item
presence or history of chronic inflammatory, autoimmune or metabolic diseases;
boolean
C1290886 (UMLS CUI [1])
C0004364 (UMLS CUI [2])
C0025517 (UMLS CUI [3])
Phenylketonuria | Hereditary fructose intolerance | Fructose Malabsorption | Malabsorption Syndrome
Item
presence of phenylketonuria, hereditary fructose intolerance, fructose malabsorption, or malabsorption syndromes;
boolean
C0031485 (UMLS CUI [1])
C0016751 (UMLS CUI [2])
C0016745 (UMLS CUI [3,1])
C3714745 (UMLS CUI [3,2])
C0024523 (UMLS CUI [4])
Substance Use Disorders | Tobacco use
Item
abuse of alcohol (>2 drinks per day), smoking, or use of recreational drugs;
boolean
C0038586 (UMLS CUI [1])
C0543414 (UMLS CUI [2])
Pharmaceutical Preparations Interfere with End Point | Insulin | Antidiabetics | Adrenergic beta-1 Receptor Antagonists | Anabolic steroids | Glucocorticoids | NSAIDs High dose Daily | warfarin | Antibiotics | Probiotics
Item
current or recent (within three months) intake of medications likely to interfere with study endpoints (insulin, antidiabetics, β-blockers, anabolic steroids, glucocorticosteroids, daily high-dose non-steroidal anti-inflammatory drugs, warfarin, antibiotics, probiotics);
boolean
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2349179 (UMLS CUI [1,3])
C0021641 (UMLS CUI [2])
C0935929 (UMLS CUI [3])
C0304516 (UMLS CUI [4])
C0002845 (UMLS CUI [5])
C0017710 (UMLS CUI [6])
C0003211 (UMLS CUI [7,1])
C0444956 (UMLS CUI [7,2])
C0332173 (UMLS CUI [7,3])
C0043031 (UMLS CUI [8])
C0003232 (UMLS CUI [9])
C0525033 (UMLS CUI [10])
Anemia | History of anemia
Item
presence of anemia, recent (within 2 months) history of anemia;
boolean
C0002871 (UMLS CUI [1])
C0559154 (UMLS CUI [2])
Food Eating Unwilling | Food Eating Unable
Item
anyone not willing or able to eat the provided food;
boolean
C0016452 (UMLS CUI [1,1])
C0013470 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0016452 (UMLS CUI [2,1])
C0013470 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
current or recent (within 12 months) pregnancy or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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