Clinical trial: Pilot Study to Evaluate the Effect of ENI Patented Whole Grape Extract on Antioxidant Status (NCT01551706)

Eligibility criteria:
Inclusion Criteria:

          1. Male or female 18 - 65 years of age

          2. If female, subject is not of child bearing potential. Defined as females who have had
             a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal
             (natural or surgically with > 1 year since last menstruation).

             OR Female subject of childbearing potential must agree to use a medically approved
             method of birth control and have a negative urine pregnancy test result. Acceptable
             methods of birth control include:

               -  Double-barrier method (condoms with spermicide or diaphragm with spermicide)

               -  Hormonal contraceptives including oral contraceptives, hormone birth control
                  patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable
                  contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)

               -  Intrauterine devices

               -  Vasectomy of partner (shown successful as per appropriate follow-up)

               -  Abstinence

          3. One or more of the following conditions:

               -  Pre-hypertension defined as diastolic blood pressure of 80-89 mmHg and systolic
                  blood pressure of 139 or lower at screening

               -  BMI from 25.0 to 34.9 kg/m2

               -  Pre-diabetes defined as a fasting plasma glucose from 5.2 to 6.9 mmol/L

          4. Subjects who are smokers agree to report smoking habits at each visit and do not plan
             on changing their smoking habits during the study.

          5. Has given voluntary, written, informed consent to participate in the study

        Exclusion Criteria:

          1. Women who are pregnant, breastfeeding, or planning to become pregnant during the
             course of the trial

          2. Subject has any clinically significant medical conditions including cardiovascular
             disease,hypertension (systolic blood pressure ≥ 140 mmHg, diastolic blood pressure ≥
             90mmHg), diabetes, liver or kidney disease

          3. Use of medication for the treatment of hypertension

          4. Use of medication for vasodilation, including nitric oxide releasing patches

          5. Use of medication for erectile dysfunction

          6. Use of medication (prescribed or over the counter) for weight loss

          7. Use of statins, fibrates, niacin, or any other medication for the treatment of
             hypercholesterolemia

          8. Use of anticoagulants

          9. Use of illicit drugs or history of drug or alcohol abuse with the past 5 years
             (currently having more than 2 standard alcoholic drinks per day)

         10. Use of natural health products (NHPs)/dietary supplements that are known to have
             significant antioxidant activity within 2 weeks prior to baseline and during the
             course of the study including but not limited to vitamins A, C, and E, selenium and
             zinc.

         11. Participation in a clinical research trial within 30 days prior to baseline

         12. Clinically significant abnormal laboratory results at screening including

               -  AST, ALT and/or bilirubin > 2 x the ULN

               -  Serum creatinine >1.5 x the ULN or eGFR < 60

               -  hemoglobin < 140 g/L for males and < 123 g/L for females

         13. Allergy or sensitivity to test product ingredients

         14. Individuals who are cognitively impaired and/or who are unable to give informed
             consent

         15. Any other condition which in the Investigator's opinion may adversely affect the
             subject's ability to complete the study or its measures or which may pose significant
             risk to the subject
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 65 Years

Patient description (medical language): A 19-year-old girl comes to the clinic due to a left wrist mass.  She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns.  Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms.

Patient description (patient's own words): I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms.

Does the patient match the trial criteria? Entailment