Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-24 @ 5:17 PM
NCT ID:
NCT01656850
Eligibility Criteria:
Inclusion Criteria:
* aged between 40-70 years,
* with BMI = 24-35 kg/m2,
* HbA1c 6.5-9 %, and
* regular use of oral hypoglycemic agents.
Exclusion Criteria:
* Use of insulin to control blood glucose
* Regular use of oral steroids
* Regular use of anti-inflammatory agents (prescribed \[Rx\] or over-the-counter \[OTC\])
* Gain or loss of larger than 5% of body weight in the last 6 months
* CVD: coronary artery disease, left ventricular hypertrophy evidenced by echocardiogram, congestive heart failure, cerebrovascular disease, stroke, peripheral vascular disease, dysautonomia
* Gastrointestinal: diseases, conditions, or medications influencing gastrointestinal absorption including active peptic ulcer disease, inflammatory bowel disease, treatment with acid-lowering drugs
* Renal: chronic kidney disease due to any condition, renovascular disease, history of nephrolithiasis, diabetic nephropathy, serum creatinine \> 1.5 mg/dL
* Endocrine: disease, untreated thyroid disease, adrenal disease, pheochromocytoma, parathyroid disease, hyperuricemia
* Rheumatologic: gout, inflammatory arthritis
* Active treatment for cancer of any type (except basal cell carcinoma) 1 year
* Systolic blood pressure larger than 150 mmHg, and diastolic blood pressure larger than 95 mmHg.
* Any history of or known allergies to nuts of any kind
* Frequent nut consumption, defined as ≥ 3 oz/wk; however, subjects who are willing to refrain from eating all nuts and nut products for 6 wk prior to their initial visit (Visit 1) may be considered eligible
* Regular use of any dietary supplements containing vitamins, minerals, herbal or other plant-based preparations, fish oil supplements (including cod liver oil) or homeopathic remedies; however, subjects who are willing to refrain from the use of these supplements for 1 mo prior to their initial visit (Visit 1) and throughout the entire study may be considered eligible
* Usual daily ethanol intake of larger or equal to 2 drinks (24 oz beer, 8 oz wine, 2 oz hard liquor)
* Illicit drug use
* Specific laboratory blood or urine analysis parameters of: creatinine larger than 1.5 mg/dL, ALT and AST larger than 1.5 nmol/L, and urinalysis - hematuria and proteinuria
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT01656850
Study Brief:
Protocol Section:
NCT01656850