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:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT01451918
Eligibility Criteria:
Inclusion Criteria:
1. Men and women, aged 23 to 60 years
2. Fasting plasma triglycerides between 2.0 and 5.0 mmol/l
3. Body mass index 25 kg/m2 to 35 kg/m2
4. Minimum body weight 64kg
5. Hemoglobin above 130g/L.
6. Research volunteers must be able to provide informed consent and be willing to comply with protocol requirements.
7. HOMA-IR (a measure of insulin resistance calculated from fasting blood glucose and insulin) \>4.0.
.
Exclusion Criteria:
1. Subject has a history of hepatitis/hepatic disease that has been active within the previous two years.
2. Any significant active (over the past 12 months) disease of the gastrointestinal, pulmonary, neurological, renal (Cr \> 1.5 mg/dL), genitourinary, hematological systems, or has severe uncontrolled treated or untreated hypertension (sitting diastolic BP \> 90 or systolic \>140) or proliferative retinopathy
3. Any dehydration or excessive vomiting
4. History of diabetes or 75g OGTT indicative of diabetes.
5. Cancer or history of cancer
6. Any history of a MI or clinically significant, active, cardiovascular history including a history of arrhythmia's or conduction delays on ECG, unstable angina, or decompensated heart failure.
7. Any active medical illness
8. Any laboratory values: AST \> 2x ULN; ALT \> 2x ULN TSH\>5mU/l or \<0.01 mU/l
9. Any clinically relevant abnormal blood/urine screening test results that are outside of the normal reference range and are significant to the investigator will be excluded
10. Any current hormonal disorder or history or hormonal disorders
11. Any bleeding disorders or autoimmune conditions
12. Any allergies to any of the ingredients in the study product or placebo ie: hypersensitivity to resveratrol, grapes, red wine, red wine polyphenols and microcrystalline microcellulose
13. Current addiction to alcohol or substances of abuse as determined by the investigator.
14. Mental incapacity, unwillingness or language barrier precluding adequate understanding or cooperation
15. Taking any prescription or non-prescription medications at the time of the study
16. Taking any natural health products during the course of the study
17. Having donated blood three months prior to and three months post study procedures
18. A pregnancy test will be performed 1 to 3 days prior to each study in all female subjects (visit #4, and visit #7 before taking study drug). Those who test positive for pregnancy will be excluded.
19. If you are breast-feeding or lactating you will be excluded from the study.
20. Women taking the oral contraceptive pill will be excluded from the study.
21. All current smokers or those who have smoked more than 1 pack per day for 5 years or more.
22. Those with ferritin levels below 50 ug/L will be excluded
23. Study Participants who experience serious adverse event or who no longer satisfy the inclusion /exclusion criteria during the trial will be withdrawn
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
23 Years
Maximum Age:
60 Years
Study:
NCT01451918
Study Brief:
Protocol Section:
NCT01451918