ID

29832

Beskrivning

Effect of Whey Protein on Blood Pressure; ODM derived from: https://clinicaltrials.gov/show/NCT00659672

Länk

https://clinicaltrials.gov/show/NCT00659672

Nyckelord

Versioner (1)
  1. 2018-04-22 2018-04-22 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

22 april 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility High Blood Pressure NCT00659672

Engelsk

Eligibility High Blood Pressure NCT00659672

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
bmi between 25 and 42 kg/m2
Beskrivning

Body mass index

Datatyp

boolean

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

Glucose measurement, fasting

Datatyp

boolean

Alias
UMLS CUI [1]
C0202045
blood pressure > 120/80 and < 160/100 mm hg [based two measurements collected on separate days]
Beskrivning

Blood pressure determination Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005824
UMLS CUI [1,2]
C1265611
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of prescription or over-the-counter medications that alter blood pressure.
Beskrivning

Pharmaceutical Preparations Changing Blood Pressure | Non-Prescription Drugs Changing Blood Pressure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C0005823
UMLS CUI [2,1]
C0013231
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C0005823
presence of kidney disease, liver disease, gout, certain cancers, thyroid disease, gastrointestinal, other metabolic diseases, or malabsorption syndromes.
Beskrivning

Kidney Diseases | Liver diseases | Gout | Malignant Neoplasms | Thyroid Diseases | Gastrointestinal Diseases | Metabolic Diseases | Malabsorption Syndrome

Datatyp

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0018099
UMLS CUI [4]
C0006826
UMLS CUI [5]
C0040128
UMLS CUI [6]
C0017178
UMLS CUI [7]
C0025517
UMLS CUI [8]
C0024523
women who have given birth during the previous 12 months.
Beskrivning

Gender | Birth

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0005615
pregnant women or women who plan to become pregnant or become pregnant during the study.
Beskrivning

Pregnancy | Pregnancy, Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
lactating women.
Beskrivning

Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0006147
type 2 diabetes requiring the use of oral antidiabetic agents or insulin.
Beskrivning

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

Datatyp

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 eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets).
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013473
UMLS CUI [1,2]
C0442809
UMLS CUI [1,3]
C0086153
UMLS CUI [2,1]
C0086152
UMLS CUI [2,2]
C0442809
UMLS CUI [2,3]
C0086153
UMLS CUI [3]
C0042441
UMLS CUI [4]
C0452296
UMLS CUI [5]
C0425403
volunteers who routinely participate in "heavy" exercise or volunteers who initiate an exercise program during the study.
Beskrivning

Strenuous Exercise Regular | Exercise Initiation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514989
UMLS CUI [1,2]
C0205272
UMLS CUI [2,1]
C0015259
UMLS CUI [2,2]
C1704686
volunteers who have lost 10% of body weight within the last 12 months.
Beskrivning

Percentage weight loss Time period

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0424661
UMLS CUI [1,2]
C1948053
use of vitamin and mineral supplements or antacids containing magnesium or calcium.
Beskrivning

Vitamin supplement | Mineral supplements | Magnesium-based antacid | Calcium antacid

Datatyp

boolean

Alias
UMLS CUI [1]
C0681579
UMLS CUI [2]
C0556112
UMLS CUI [3]
C0304544
UMLS CUI [4]
C0304542
use of prescription or over-the-counter antiobesity medications or supplements (e.g., phenylpropanalamine, ephedrine, caffeine, during and for at least 6 months prior to the start of the study) or history of a surgical intervention for obesity.
Beskrivning

Anti-Obesity Agents Prescription | Anti-Obesity Agents Non-Prescription | Phenylpropanolamine | Ephedrine | Caffeine | Obesity surgery

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0376607
UMLS CUI [1,2]
C0033081
UMLS CUI [2,1]
C0376607
UMLS CUI [2,2]
C0013231
UMLS CUI [3]
C0031495
UMLS CUI [4]
C0014479
UMLS CUI [5]
C0006644
UMLS CUI [6]
C1167841
active cardiovascular disease (such as heart attack or procedure within the past three months or participation in a cardiac rehabilitation program within last three months, stroke or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in past six months).
Beskrivning

Cardiovascular Diseases | Myocardial Infarction | Procedure on heart | Cardiac rehabilitation | Cerebrovascular accident | Transient Ischemic Attack | Pulmonary Embolism

Datatyp

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0027051
UMLS CUI [3]
C1279986
UMLS CUI [4]
C0700431
UMLS CUI [5]
C0038454
UMLS CUI [6]
C0007787
UMLS CUI [7]
C0034065
smokers or other tobacco users (during the 6 months prior to the start of the study).
Beskrivning

Tobacco use

Datatyp

boolean

Alias
UMLS CUI [1]
C0543414
known (self-reported) allergy or adverse reaction to dairy products (including lactose) or soy.
Beskrivning

Allergy to dairy product | Adverse reactions Dairy Products | FOOD ALLERGY TO LACTOSE | Adverse reactions Lactose | Allergy to soya | Adverse reactions Soy

Datatyp

boolean

Alias
UMLS CUI [1]
C1960715
UMLS CUI [2,1]
C0559546
UMLS CUI [2,2]
C0010947
UMLS CUI [3]
C0744078
UMLS CUI [4,1]
C0559546
UMLS CUI [4,2]
C0022949
UMLS CUI [5]
C4075590
UMLS CUI [6,1]
C0559546
UMLS CUI [6,2]
C0037733
unable or unwilling to give informed consent or communicate with study staff.
Beskrivning

Informed Consent Unable | Informed Consent Unwilling | Communication Research Personnel Unable | Communication Research Personnel Unwilling

Datatyp

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]
C0009452
UMLS CUI [3,2]
C0035173
UMLS CUI [3,3]
C1299582
UMLS CUI [4,1]
C0009452
UMLS CUI [4,2]
C0035173
UMLS CUI [4,3]
C0558080
self-report of alcohol or substance abuse within the past twelve months and/or current acute treatment or rehabilitation program for these problems (long-term participation in alcoholics anonymous is not an exclusion.)
Beskrivning

Substance Use Disorders | Alcohol/drug treatment patient | Drug and alcohol rehabilitation

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C1549591
UMLS CUI [3]
C0810435
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.
Beskrivning

Medical Problem Interferes with Study Subject Participation Status | Mental problem Interferes with Study Subject Participation Status | Behavior problem Interferes with Study Subject Participation Status | Medical Problem Interferes with Protocol Compliance | Mental problem Interferes with Protocol Compliance | Behavior problem Interferes with Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1254481
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C0848067
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]
C1254481
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0525058
UMLS CUI [5,1]
C0848067
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 High Blood Pressure NCT00659672

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Body mass index
Item
bmi between 25 and 42 kg/m2
boolean
C1305855 (UMLS CUI [1])
Glucose measurement, fasting
Item
fasting glucose < 126 mg/dl
boolean
C0202045 (UMLS CUI [1])
Blood pressure determination Quantity
Item
blood pressure > 120/80 and < 160/100 mm hg [based two measurements collected on separate days]
boolean
C0005824 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Pharmaceutical Preparations Changing Blood Pressure | Non-Prescription Drugs Changing Blood Pressure
Item
use of prescription or over-the-counter medications that alter blood pressure.
boolean
C0013227 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0005823 (UMLS CUI [1,3])
C0013231 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0005823 (UMLS CUI [2,3])
Kidney Diseases | Liver diseases | Gout | Malignant Neoplasms | Thyroid Diseases | Gastrointestinal Diseases | Metabolic Diseases | Malabsorption Syndrome
Item
presence of kidney disease, liver disease, gout, certain cancers, thyroid disease, gastrointestinal, other metabolic diseases, or malabsorption syndromes.
boolean
C0022658 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0018099 (UMLS CUI [3])
C0006826 (UMLS CUI [4])
C0040128 (UMLS CUI [5])
C0017178 (UMLS CUI [6])
C0025517 (UMLS CUI [7])
C0024523 (UMLS CUI [8])
Gender | Birth
Item
women who have given birth during the previous 12 months.
boolean
C0079399 (UMLS CUI [1])
C0005615 (UMLS CUI [2])
Pregnancy | Pregnancy, Planned
Item
pregnant women or women who plan to become pregnant or become pregnant during the study.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Breast Feeding
Item
lactating women.
boolean
C0006147 (UMLS CUI [1])
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])
Eating Disorders Inconsistent Dietary intervention | Dietary Habits 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 [1,1])
C0442809 (UMLS CUI [1,2])
C0086153 (UMLS CUI [1,3])
C0086152 (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])
Strenuous Exercise Regular | Exercise Initiation
Item
volunteers who routinely participate in "heavy" exercise or volunteers who initiate an exercise program during the study.
boolean
C1514989 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0015259 (UMLS CUI [2,1])
C1704686 (UMLS CUI [2,2])
Percentage weight loss Time period
Item
volunteers who have lost 10% of body weight within the last 12 months.
boolean
C0424661 (UMLS CUI [1,1])
C1948053 (UMLS CUI [1,2])
Vitamin supplement | Mineral supplements | Magnesium-based antacid | Calcium antacid
Item
use of vitamin and mineral supplements or antacids containing magnesium or calcium.
boolean
C0681579 (UMLS CUI [1])
C0556112 (UMLS CUI [2])
C0304544 (UMLS CUI [3])
C0304542 (UMLS CUI [4])
Anti-Obesity Agents Prescription | Anti-Obesity Agents Non-Prescription | Phenylpropanolamine | Ephedrine | Caffeine | Obesity surgery
Item
use of prescription or over-the-counter antiobesity medications or supplements (e.g., phenylpropanalamine, ephedrine, caffeine, during and for at least 6 months prior to the start of the study) or history of a surgical intervention for obesity.
boolean
C0376607 (UMLS CUI [1,1])
C0033081 (UMLS CUI [1,2])
C0376607 (UMLS CUI [2,1])
C0013231 (UMLS CUI [2,2])
C0031495 (UMLS CUI [3])
C0014479 (UMLS CUI [4])
C0006644 (UMLS CUI [5])
C1167841 (UMLS CUI [6])
Cardiovascular Diseases | Myocardial Infarction | Procedure on heart | Cardiac rehabilitation | Cerebrovascular accident | Transient Ischemic Attack | Pulmonary Embolism
Item
active cardiovascular disease (such as heart attack or procedure within the past three months or participation in a cardiac rehabilitation program within last three months, stroke or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in past six months).
boolean
C0007222 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C1279986 (UMLS CUI [3])
C0700431 (UMLS CUI [4])
C0038454 (UMLS CUI [5])
C0007787 (UMLS CUI [6])
C0034065 (UMLS CUI [7])
Tobacco use
Item
smokers or other tobacco users (during the 6 months prior to the start of the study).
boolean
C0543414 (UMLS CUI [1])
Allergy to dairy product | Adverse reactions Dairy Products | FOOD ALLERGY TO LACTOSE | Adverse reactions Lactose | Allergy to soya | Adverse reactions Soy
Item
known (self-reported) allergy or adverse reaction to dairy products (including lactose) or soy.
boolean
C1960715 (UMLS CUI [1])
C0559546 (UMLS CUI [2,1])
C0010947 (UMLS CUI [2,2])
C0744078 (UMLS CUI [3])
C0559546 (UMLS CUI [4,1])
C0022949 (UMLS CUI [4,2])
C4075590 (UMLS CUI [5])
C0559546 (UMLS CUI [6,1])
C0037733 (UMLS CUI [6,2])
Informed Consent Unable | Informed Consent Unwilling | Communication Research Personnel Unable | Communication Research Personnel Unwilling
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])
C0009452 (UMLS CUI [3,1])
C0035173 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
C0009452 (UMLS CUI [4,1])
C0035173 (UMLS CUI [4,2])
C0558080 (UMLS CUI [4,3])
Substance Use Disorders | Alcohol/drug treatment patient | Drug and alcohol rehabilitation
Item
self-report of alcohol or substance abuse within the past twelve 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])
C1549591 (UMLS CUI [2])
C0810435 (UMLS CUI [3])
Medical Problem Interferes with Study Subject Participation Status | Mental problem Interferes with Study Subject Participation Status | Behavior problem Interferes with Study Subject Participation Status | Medical Problem Interferes with Protocol Compliance | Mental problem Interferes with Protocol Compliance | Behavior problem 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
C1254481 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0848067 (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])
C1254481 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
C0848067 (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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