{
"info": {
"nct_id": "NCT00467220",
"official_title": "Effect of Daily Calorie Restriction or Alternate-day Reductions in Calorie Intake on Risk for Cardiovascular Disease and Cancer",
"inclusion_criteria": "* Male and female; body mass index (BMI) between 20-30 kg/m2;\n* Age between 35-65 years; sedentary (light exercise less than 1h per week) or moderately active (1 to 2h per week);\n* Weight stable for >3 months prior to the beginning of the study;\n* Able to give written informed consent;\n* Female subjects must be post-menopausal for at least 2 years and can not be on hormone replacement therapy (HRT).\nHealthy volunteers allowed\nMust have minimum age of 35 Years\nMust have maximum age of 65 Years",
"exclusion_criteria": "* Diabetic;\n* History of cardiovascular disease, i.e. myocardial infarction or stroke;\n* History of cancer;\n* Taking glucose lowering medication;\n* Taking weight loss medication",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Male and female; body mass index (BMI) between 20-30 kg/m2;",
"criterions": [
{
"exact_snippets": "Male and female",
"criterion": "gender",
"requirements": [
{
"requirement_type": "allowed_values",
"expected_value": [
"male",
"female"
]
}
]
},
{
"exact_snippets": "body mass index (BMI) between 20-30 kg/m2",
"criterion": "body mass index (BMI)",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 20,
"unit": "kg/m2"
},
{
"operator": "<=",
"value": 30,
"unit": "kg/m2"
}
]
}
}
]
}
]
},
{
"line": "* Age between 35-65 years; sedentary (light exercise less than 1h per week) or moderately active (1 to 2h per week);",
"criterions": [
{
"exact_snippets": "Age between 35-65 years",
"criterion": "age",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 35,
"unit": "years"
},
{
"operator": "<=",
"value": 65,
"unit": "years"
}
]
}
}
]
},
{
"exact_snippets": "sedentary (light exercise less than 1h per week)",
"criterion": "physical activity level",
"requirements": [
{
"requirement_type": "activity level",
"expected_value": "sedentary"
}
]
},
{
"exact_snippets": "moderately active (1 to 2h per week)",
"criterion": "physical activity level",
"requirements": [
{
"requirement_type": "activity level",
"expected_value": "moderately active"
}
]
}
]
},
{
"line": "* Weight stable for >3 months prior to the beginning of the study;",
"criterions": [
{
"exact_snippets": "Weight stable for >3 months",
"criterion": "weight stability",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">",
"value": 3,
"unit": "months"
}
}
]
}
]
},
{
"line": "* Able to give written informed consent;",
"criterions": [
{
"exact_snippets": "Able to give written informed consent",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "ability",
"expected_value": true
}
]
}
]
},
{
"line": "* Female subjects must be post-menopausal for at least 2 years and can not be on hormone replacement therapy (HRT).",
"criterions": [
{
"exact_snippets": "Female subjects must be post-menopausal for at least 2 years",
"criterion": "menopausal status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "post-menopausal"
},
{
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "years"
}
}
]
},
{
"exact_snippets": "can not be on hormone replacement therapy (HRT)",
"criterion": "hormone replacement therapy",
"requirements": [
{
"requirement_type": "usage",
"expected_value": false
}
]
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "Must have minimum age of 35 Years",
"criterions": [
{
"exact_snippets": "minimum age of 35 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 35,
"unit": "Years"
}
}
]
}
]
},
{
"line": "Must have maximum age of 65 Years",
"criterions": [
{
"exact_snippets": "maximum age of 65 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 65,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* Diabetic;",
"criterions": [
{
"exact_snippets": "Diabetic",
"criterion": "diabetes",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* History of cardiovascular disease, i.e. myocardial infarction or stroke;",
"criterions": [
{
"exact_snippets": "History of cardiovascular disease, i.e. myocardial infarction",
"criterion": "myocardial infarction",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
},
{
"exact_snippets": "History of cardiovascular disease, i.e. ... stroke",
"criterion": "stroke",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
}
]
},
{
"line": "* History of cancer;",
"criterions": [
{
"exact_snippets": "History of cancer",
"criterion": "cancer history",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Taking glucose lowering medication;",
"criterions": [
{
"exact_snippets": "Taking glucose lowering medication",
"criterion": "glucose lowering medication",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Taking weight loss medication",
"criterions": [
{
"exact_snippets": "Taking weight loss medication",
"criterion": "weight loss medication",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}