ID

35876

Description

Determining the Potential of Wholegrain Wheat and Rye to Improve Gut HealTh; ODM derived from: https://clinicaltrials.gov/show/NCT02358122

Link

https://clinicaltrials.gov/show/NCT02358122

Keywords

Versions (1)
  1. 3/31/19 3/31/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 31, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Gastrointestinal Diseases NCT02358122

English

Eligibility Gastrointestinal Diseases NCT02358122

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
• age: 30 - 65 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
body mass index (bmi): 25 - 32 kg/m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
weight stable (<3 kg weight change during the last 6 months)
Description

Stable body weight

Data type

boolean

Alias
UMLS CUI [1]
C0517386
apparently healthy
Description

Healthy

Data type

boolean

Alias
UMLS CUI [1]
C3898900
informed consent signed
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
freezer capacity for 2 weeks bread provision
Description

Freezer Capacity Bread

Data type

boolean

Alias
UMLS CUI [1,1]
C0175738
UMLS CUI [1,2]
C1516240
UMLS CUI [1,3]
C0006138
can attend all visits required for the study
Description

Adherence Clinical Trial Visits

Data type

boolean

Alias
UMLS CUI [1,1]
C1510802
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0008952
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
• smoking on a daily basis
Description

Tobacco use Daily

Data type

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0332173
lactating (or lactating within 6 weeks prior to study start), pregnant (or pregnant within 3 months prior to study start) or wish to become pregnant during the study
Description

Breast Feeding | Pregnancy | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0032992
diagnosed with any form of diabetes or cvd
Description

Diabetes Mellitus | Cardiovascular Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0007222
reported chronic gi disorders
Description

Gastrointestinal Diseases chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0205191
antibiotic treatment 3 month before study start and during the study
Description

Antibiotic therapy

Data type

boolean

Alias
UMLS CUI [1]
C0338237
use of pre- or probiotic 1 month before study start and during the study
Description

Prebiotics | Probiotics

Data type

boolean

Alias
UMLS CUI [1]
C2717875
UMLS CUI [2]
C0525033
lack of cooperation and adherence to the protocol
Description

Cooperation Lacking | Protocol Compliance Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C0392337
UMLS CUI [1,2]
C0332268
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C0332268
use of prescription medication will be evaluated on an individual basis
Description

Prescription Drugs Evaluation

Data type

boolean

Alias
UMLS CUI [1,1]
C0304227
UMLS CUI [1,2]
C1261322
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Similar models

Eligibility Gastrointestinal Diseases NCT02358122

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
• age: 30 - 65 years
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi): 25 - 32 kg/m2
boolean
C1305855 (UMLS CUI [1])
Stable body weight
Item
weight stable (<3 kg weight change during the last 6 months)
boolean
C0517386 (UMLS CUI [1])
Healthy
Item
apparently healthy
boolean
C3898900 (UMLS CUI [1])
Informed Consent
Item
informed consent signed
boolean
C0021430 (UMLS CUI [1])
Freezer Capacity Bread
Item
freezer capacity for 2 weeks bread provision
boolean
C0175738 (UMLS CUI [1,1])
C1516240 (UMLS CUI [1,2])
C0006138 (UMLS CUI [1,3])
Adherence Clinical Trial Visits
Item
can attend all visits required for the study
boolean
C1510802 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0008952 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Tobacco use Daily
Item
• smoking on a daily basis
boolean
C0543414 (UMLS CUI [1,1])
C0332173 (UMLS CUI [1,2])
Breast Feeding | Pregnancy | Pregnancy, Planned
Item
lactating (or lactating within 6 weeks prior to study start), pregnant (or pregnant within 3 months prior to study start) or wish to become pregnant during the study
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Diabetes Mellitus | Cardiovascular Diseases
Item
diagnosed with any form of diabetes or cvd
boolean
C0011849 (UMLS CUI [1])
C0007222 (UMLS CUI [2])
Gastrointestinal Diseases chronic
Item
reported chronic gi disorders
boolean
C0017178 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Antibiotic therapy
Item
antibiotic treatment 3 month before study start and during the study
boolean
C0338237 (UMLS CUI [1])
Prebiotics | Probiotics
Item
use of pre- or probiotic 1 month before study start and during the study
boolean
C2717875 (UMLS CUI [1])
C0525033 (UMLS CUI [2])
Cooperation Lacking | Protocol Compliance Lacking
Item
lack of cooperation and adherence to the protocol
boolean
C0392337 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
Prescription Drugs Evaluation
Item
use of prescription medication will be evaluated on an individual basis
boolean
C0304227 (UMLS CUI [1,1])
C1261322 (UMLS CUI [1,2])
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