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:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-26 @ 1:16 PM
NCT ID:
NCT01161706
Eligibility Criteria:
\*\*\*Inclusion Criteria\*\*\*
* Age 40 to 65 yrs
* Subject's body mass index is between 18.5 - 34.9 kg/m2
* Subject is willing and able to comply with the study protocols
* Subject is willing to consume a vegetable-based beverage daily for three months
\*\*\*Exclusion Criteria\*\*\*
* Physical signs of health impairment
* Uncontrolled diabetes or hypertension
* Pregnant or lactating
* Active tuberculosis or lung disease (i.e. COPD)
* Renal or Liver disease
* Heart Disease, which includes Cardiovascular events and Stroke
* Cushing's syndrome
* Exercise trained individuals
* History of psychiatric disorders i.e. schizophrenia or bi-polar or depression treated with antidepressants within the last 1 year
* Anxiety medications
* Use of MAOI inhibitors within the last 1 year (e.g., phenelzine (Nardil), tranylcypromine (Parnate), etc.)
* Quality of life score of 21 or above
* Routine use of prescription drugs or over-the counter medications, which may potentially modulate the outcome of this study; including antibiotics, aspirin and aspirin-containing formulations, COX-2 inhibitors, antihistamines, corticosteroids, erectile dysfunction drugs
* Asthma (can be worsened by mild to moderate food allergies)
* Indications of substance or alcohol abuse within the last 3 years
* The volunteer is undergoing nicotine cessation therapy
* Laboratory values outside the reference range if determined to be clinically significant by Dr. M. Eric Gershwin
* Individuals with known salt-sensitive hypertension
* History of stage 1 high blood pressure defined as systolic \> 140 and diastolic \> 90, with or without use of HTN medications
* Multi-Vitamin use other than a One-A-Day essential
* Use of herbal or plant-based supplements; omega-3 fatty acids, and fish oils and unwilling to discontinue use while participating in the study
* Allergies to vegetables
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT01161706
Study Brief:
Protocol Section:
NCT01161706