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 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT02112851
Eligibility Criteria:
Inclusion Criteria:
* Males (due to potential hormonal fluctuations in female subjects) aged 30-65 y
* BMI: 25-29.9 kg/m2
* Not diabetic \[diagnosed or fasting glucose \>7 mmol/L (126 mg/dL)\] or suffer from other endocrine disorders
* Not having suffered a myocardial infarction/stroke in the past 12 mo
* Not suffering from renal or bowel disease or have a history of choleostatic liver or pancreatitis
* Not on drug treatment for hyperlipidaemia, hypertension, inflammation or hypercoagulation
* No history of alcohol misuse
* Not planning or on a weight reducing regime
* Not taking any fish oil, fatty acid or vitamin and mineral supplements
* Non smokers
Exclusion Criteria:
* Females
* Use of medications known to affect lipid metabolism, i.e., hypolipidemic or cholesterol-lowering agents (e.g., Pravastatin, Simuvustatin)
* Use of (\>2x/wk) medication for inflammation or hypercoagulation
* Anticoagulants (Warfarin)
* Inflammation - NSAID's (Tiaprofenic acid, Sulindac, Ibuprofen), Corticosteroids (Betamethasone)
* Regular use (\>2x/wk) of any acid-lowering medications, laxatives or anti-diarrheal medications (prescription or over-the-counter \[OTC\])
* Use of medications known or suspected to influence blood pressure, including beta-adrenergic blocking agents (oral or ocular) (e.g., Sotalol, Bisoprolol), beta-adrenergic drugs, calcium channel blocking agents (Amlodipine, Nicardipine), angiotensin converting enzyme (ACE) inhibitors (Captopril, Cilazapril), angiotensin receptor blocking agents (Valsartan), nitrates, diuretics (Chlortalidone), venlafaxine and sibutramine, decongestants or chloroquine
* Systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>95 mmHg
* CVD including coronary artery disease, left ventricular hypertrophy, congestive heart failure, cerebrovascular disease, stroke, peripheral vascular disease or dysautonomia
* Gastrointestinal diseases conditions or medications influencing gastrointestinal absorption including active peptic ulcer disease, treatment with acid-lowering drugs or inflammatory bowel disease
* Renal or chronic kidney disease due to any condition, renovascular disease, history of nephrolithiasis or serum creatinine \>1.5 mg/dL
* Endocrine disorders including diabetes \[fasting blood glucose \>7 mmol/L (126 mg/dL) or current pharmacologic treatment for diabetes\], untreated thyroid disease, adrenal disease, pheochromocytoma, parathyroid disease or hyperuricemia
* Rheumatologic diseases including gout or inflammatory arthritis
* Active treatment for cancer of any type (except basal cell carcinoma)\<1 y
* Regular use of oral steroids except topical OTC steroids
* 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 3) may be considered eligible.
* Usual daily ethanol intake of\>2 drinks (24 oz beer, 8 oz wine, 2 oz hard liquor)
* Cigarette smoking and/or nicotine replacement use. However, subjects who have stopped using these products for 1 y prior to their initial visit (Visit 1) may be considered eligible.
* Illicit drug use
* Infrequent (\<3/wk) or excessive (\>3/d) number of regular bowel movements
* Specific laboratory blood or urine analysis parameters of:
* Creatinine \> 1.5 mg/dL
* Electrolytes, calcium, phosphorous - out of normal ranges
* ALT and AST \>1.5 nmol
* Total bilirubin - above normal range
* Triglycerides ≥300 mg/dL
* Fasting glucose ≥126 mg/dL
* CBC: HCT outside of normal NEL reference ranges at the discretion of the study physician
* WBC, PLT - outside of normal NEL reference ranges Strict vegetarians
* Those on or planning a weight reducing regime
* Unable to consume study meals or products
* Subjects with larger than 5 kg weight loss in the last 3 months.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
30 Years
Maximum Age:
65 Years
Study:
NCT02112851
Study Brief:
Protocol Section:
NCT02112851