ID

29319

Description

Energy Value of Macronutrients From Pistachio Nuts and Mechanisms of Nutrient Action; ODM derived from: https://clinicaltrials.gov/show/NCT00942695

Lien

https://clinicaltrials.gov/show/NCT00942695

Mots-clés

Versions (1)
  1. 18/03/2018 18/03/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

18 mars 2018

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Energy NCT00942695

Anglais

Eligibility Energy NCT00942695

1 Formulaires  
  1. StudyEvent: Eligibility
    1. Eligibility Energy NCT00942695
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 25 to 65 years at beginning of study
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
bmi between 20 and 38 kg/m2
Description

Body mass index

Type de données

boolean

Alias
UMLS CUI [1]
C1305855
fasting glucose < 126 mg/dl
Description

Glucose measurement, fasting

Type de données

boolean

Alias
UMLS CUI [1]
C0202045
blood pressure < 160/100 (controlled with certain medications)
Description

Blood pressure determination Controlled by Pharmaceutical Preparations

Type de données

boolean

Alias
UMLS CUI [1,1]
C0005824
UMLS CUI [1,2]
C0332298
UMLS CUI [1,3]
C0013227
fasting total blood cholesterol < 280 mg/dl
Description

Measurement of total cholesterol in whole blood Fasting

Type de données

boolean

Alias
UMLS CUI [1,1]
C3525706
UMLS CUI [1,2]
C0015663
fasting triglycerides < 300 mg/dl
Description

Serum fasting triglyceride measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0582824
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
presence of kidney disease, liver disease, gout, hyperthyroidism, untreated or unstable hypothyroidism, certain cancers, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes
Description

Kidney Disease | Liver disease | Gout | Hyperthyroidism | Hypothyroidism (if untreated) | Hypothyroidism Unstable | Malignant Neoplasms | Gastrointestinal Diseases | Pancreatic Diseases | Metabolic Diseases | Malabsorption Syndrome

Type de données

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0018099
UMLS CUI [4]
C0020550
UMLS CUI [5]
C2749407
UMLS CUI [6,1]
C0020676
UMLS CUI [6,2]
C0443343
UMLS CUI [7]
C0006826
UMLS CUI [8]
C0017178
UMLS CUI [9]
C0030286
UMLS CUI [10]
C0025517
UMLS CUI [11]
C0024523
type 2 diabetes requiring the use of oral antidiabetic agents or insulin
Description

Non-Insulin-Dependent Diabetes Mellitus Requirement Antidiabetics Oral | Non-Insulin-Dependent Diabetes Mellitus Requirement Insulin

Type de données

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0935929
UMLS CUI [1,4]
C1527415
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0021641
history of bariatric or certain other surgeries related to weight control
Description

Bariatric Surgery Relationship Weight control | Operative Surgical Procedures Relationship Weight control

Type de données

boolean

Alias
UMLS CUI [1,1]
C1456587
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0920298
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C0920298
smokers or other tobacco users (during 6 months prior to the start of the study)
Description

Tobacco use

Type de données

boolean

Alias
UMLS CUI [1]
C0543414
antibiotic use during the intervention or for 3 weeks prior to any intervention period
Description

Antibiotics

Type de données

boolean

Alias
UMLS CUI [1]
C0003232
history of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
Description

Eating Disorders | Food Patterns Inconsistent Dietary intervention | Vegetarian | Very low fat diet | Increased protein diet

Type de données

boolean

Alias
UMLS CUI [1]
C0013473
UMLS CUI [2,1]
C1517289
UMLS CUI [2,2]
C0442809
UMLS CUI [2,3]
C0086153
UMLS CUI [3]
C0042441
UMLS CUI [4]
C0452296
UMLS CUI [5]
C0425403
volunteers who have lost 10% of body weight within the last 12 months or who plan to initiate a weight loss program during the next 10 months
Description

Weight decreased Percent Time Period | Weight Reduction Program Planned

Type de données

boolean

Alias
UMLS CUI [1,1]
C1262477
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C1948053
UMLS CUI [2,1]
C3179079
UMLS CUI [2,2]
C1301732
known (self-reported) allergy or adverse reaction to pistachios or other nuts
Description

Hypersensitivity Pistachios | Adverse reactions Pistachios | Nut Hypersensitivity | Adverse reactions Nuts

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0459819
UMLS CUI [2,1]
C0559546
UMLS CUI [2,2]
C0459819
UMLS CUI [3]
C0577620
UMLS CUI [4,1]
C0559546
UMLS CUI [4,2]
C0028723
unable or unwilling to give informed consent or communicate with study staff
Description

Informed Consent Unable | Informed Consent Unwilling | Lacking Able to communicate Research Personnel

Type de données

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0558080
UMLS CUI [3,1]
C0332268
UMLS CUI [3,2]
C2364293
UMLS CUI [3,3]
C0035173
self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in alcoholics anonymous is not an exclusion)
Description

Substance Use Disorders | Therapeutic procedure Substance Use Disorders | Rehabilitation program Substance Use Disorders | Exception Participation Long-term Alcoholics Anonymous

Type de données

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0038586
UMLS CUI [3,1]
C0034991
UMLS CUI [3,2]
C0038586
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0679823
UMLS CUI [4,3]
C0443252
UMLS CUI [4,4]
C0001972
other medical, psychiatric, or behavioral factors that in the judgment of the principal investigator may interfere with study participation or the ability to follow the intervention protocol
Description

Medical condition Interferes with Study Subject Participation Status | Psychiatric problem Interferes with Study Subject Participation Status | Abnormal behavior Interferes with Study Subject Participation Status | Medical condition Interferes with Protocol Compliance | Psychiatric problem Interferes with Protocol Compliance | Abnormal behavior Interferes with Protocol Compliance

Type de données

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C1306597
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2348568
UMLS CUI [3,1]
C0233514
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C2348568
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0525058
UMLS CUI [5,1]
C1306597
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0525058
UMLS CUI [6,1]
C0233514
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C0525058
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Similar models

Eligibility Energy NCT00942695

1 Formulaires
  1. StudyEvent: Eligibility
    1. Eligibility Energy NCT00942695
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 25 to 65 years at beginning of study
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
bmi between 20 and 38 kg/m2
boolean
C1305855 (UMLS CUI [1])
Glucose measurement, fasting
Item
fasting glucose < 126 mg/dl
boolean
C0202045 (UMLS CUI [1])
Blood pressure determination Controlled by Pharmaceutical Preparations
Item
blood pressure < 160/100 (controlled with certain medications)
boolean
C0005824 (UMLS CUI [1,1])
C0332298 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Measurement of total cholesterol in whole blood Fasting
Item
fasting total blood cholesterol < 280 mg/dl
boolean
C3525706 (UMLS CUI [1,1])
C0015663 (UMLS CUI [1,2])
Serum fasting triglyceride measurement
Item
fasting triglycerides < 300 mg/dl
boolean
C0582824 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Kidney Disease | Liver disease | Gout | Hyperthyroidism | Hypothyroidism (if untreated) | Hypothyroidism Unstable | Malignant Neoplasms | Gastrointestinal Diseases | Pancreatic Diseases | Metabolic Diseases | Malabsorption Syndrome
Item
presence of kidney disease, liver disease, gout, hyperthyroidism, untreated or unstable hypothyroidism, certain cancers, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes
boolean
C0022658 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0018099 (UMLS CUI [3])
C0020550 (UMLS CUI [4])
C2749407 (UMLS CUI [5])
C0020676 (UMLS CUI [6,1])
C0443343 (UMLS CUI [6,2])
C0006826 (UMLS CUI [7])
C0017178 (UMLS CUI [8])
C0030286 (UMLS CUI [9])
C0025517 (UMLS CUI [10])
C0024523 (UMLS CUI [11])
Non-Insulin-Dependent Diabetes Mellitus Requirement Antidiabetics Oral | Non-Insulin-Dependent Diabetes Mellitus Requirement Insulin
Item
type 2 diabetes requiring the use of oral antidiabetic agents or insulin
boolean
C0011860 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0935929 (UMLS CUI [1,3])
C1527415 (UMLS CUI [1,4])
C0011860 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0021641 (UMLS CUI [2,3])
Bariatric Surgery Relationship Weight control | Operative Surgical Procedures Relationship Weight control
Item
history of bariatric or certain other surgeries related to weight control
boolean
C1456587 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0920298 (UMLS CUI [1,3])
C0543467 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0920298 (UMLS CUI [2,3])
Tobacco use
Item
smokers or other tobacco users (during 6 months prior to the start of the study)
boolean
C0543414 (UMLS CUI [1])
Antibiotics
Item
antibiotic use during the intervention or for 3 weeks prior to any intervention period
boolean
C0003232 (UMLS CUI [1])
Eating Disorders | Food Patterns Inconsistent Dietary intervention | Vegetarian | Very low fat diet | Increased protein diet
Item
history of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
boolean
C0013473 (UMLS CUI [1])
C1517289 (UMLS CUI [2,1])
C0442809 (UMLS CUI [2,2])
C0086153 (UMLS CUI [2,3])
C0042441 (UMLS CUI [3])
C0452296 (UMLS CUI [4])
C0425403 (UMLS CUI [5])
Weight decreased Percent Time Period | Weight Reduction Program Planned
Item
volunteers who have lost 10% of body weight within the last 12 months or who plan to initiate a weight loss program during the next 10 months
boolean
C1262477 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C1948053 (UMLS CUI [1,3])
C3179079 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Hypersensitivity Pistachios | Adverse reactions Pistachios | Nut Hypersensitivity | Adverse reactions Nuts
Item
known (self-reported) allergy or adverse reaction to pistachios or other nuts
boolean
C0020517 (UMLS CUI [1,1])
C0459819 (UMLS CUI [1,2])
C0559546 (UMLS CUI [2,1])
C0459819 (UMLS CUI [2,2])
C0577620 (UMLS CUI [3])
C0559546 (UMLS CUI [4,1])
C0028723 (UMLS CUI [4,2])
Informed Consent Unable | Informed Consent Unwilling | Lacking Able to communicate Research Personnel
Item
unable or unwilling to give informed consent or communicate with study staff
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
C0332268 (UMLS CUI [3,1])
C2364293 (UMLS CUI [3,2])
C0035173 (UMLS CUI [3,3])
Substance Use Disorders | Therapeutic procedure Substance Use Disorders | Rehabilitation program Substance Use Disorders | Exception Participation Long-term Alcoholics Anonymous
Item
self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in alcoholics anonymous is not an exclusion)
boolean
C0038586 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0038586 (UMLS CUI [2,2])
C0034991 (UMLS CUI [3,1])
C0038586 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0679823 (UMLS CUI [4,2])
C0443252 (UMLS CUI [4,3])
C0001972 (UMLS CUI [4,4])
Medical condition Interferes with Study Subject Participation Status | Psychiatric problem Interferes with Study Subject Participation Status | Abnormal behavior Interferes with Study Subject Participation Status | Medical condition Interferes with Protocol Compliance | Psychiatric problem Interferes with Protocol Compliance | Abnormal behavior Interferes with Protocol Compliance
Item
other medical, psychiatric, or behavioral factors that in the judgment of the principal investigator may interfere with study participation or the ability to follow the intervention protocol
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C1306597 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0233514 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C3843040 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
C1306597 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0525058 (UMLS CUI [5,3])
C0233514 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
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