Regulation of Intestinal and Hepatic Lipoprotein Secretion by Resveratrol

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Resveratrol, an ingredient of red wine and available in Canada in highly purified form as an over-the-counter health supplement, has been shown to have a number of health benefits. Data from in vitro and animal studies suggest that it has beneficial effects on insulin sensitivity and lipid lowering. The investigators are not aware, however, of any mechanistic studies that have examined the effect of highly purified resveratrol in vivo on lipoprotein metabolism in humans. Given the potential therapeutic benefit of resveratrol in correcting the metabolic abnormalities of insulin resistant individuals the investigators plan to examine the effects of resveratrol on intestinal and hepatic lipoprotein production in humans.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Health Network, Toronto
• Collaborator: Canadian Institutes of Health Research (CIHR)
• Treatments: Resveratrol

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.

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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