Insulin Resistance Clinical Trial
Official title:
Regulation of Intestinal (and Hepatic) Lipoprotein Secretion by Resveratrol
Verified date | May 2012 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 8 |
Est. completion date | September 2013 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 23 Years to 60 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Canada | Toronto General Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto | Canadian Institutes of Health Research (CIHR) |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Examine the effect of resveratrol on ApoB 100 and ApoB 48 production in humans | 10 hour lipoprotein turnover study as described above following 2 weeks treatment with resveratrol or placebo. | 2 weeks | No |
Secondary | Assess the change in insulin sensitivity with resveratrol treatment | HOMA-IR calculated from fasting insulin and fasting glucose will be used to assess change in insulin sensitivity before and after 2 weeks of resveratrol treatment. | 2 weeks | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03142633 -
MicroRNA as Biomarkers for Development of Metabolic Syndrome in Women With Polycystic Ovary Syndrome
|
||
Recruiting |
NCT04984226 -
Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD
|
Phase 2 | |
Recruiting |
NCT05354245 -
Using a Complex Carbohydrate Mixture to Steer Fermentation and Improve Metabolism in Adults With Overweight and Prediabetes (DISTAL)
|
N/A | |
Completed |
NCT03383822 -
Regulation of Endogenous Glucose Production by Brain Insulin Action in Insulin Resistance
|
Phase 1/Phase 2 | |
Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
Suspended |
NCT03652987 -
Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS)
|
||
Completed |
NCT04203238 -
Potato Research for Enhancing Metabolic Outcomes
|
N/A | |
Recruiting |
NCT03658564 -
Preoperative Oral Carbohydrate Treatment Minimizes Insulin Resistance
|
N/A | |
Completed |
NCT04183257 -
Effect of Escalating Oral Vitamin D Replacement on HOMA-IR in Vitamin D Deficient Type 2 Diabetics
|
Phase 4 | |
Completed |
NCT04117802 -
Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome
|
N/A | |
Completed |
NCT03627104 -
Effect of Dietary Protein and Energy Restriction in the Improvement of Insulin Resistance in Subjects With Obesity
|
N/A | |
Completed |
NCT05124847 -
TREating Pediatric Obesity
|
N/A | |
Active, not recruiting |
NCT03288025 -
Pulmonary Arterial Hypertension Improvement With Nutrition and Exercise (PHINE)
|
N/A | |
Completed |
NCT03809182 -
Effect of Dexmedetomidine on Postoperative Glucose and Insulin Levels.
|
Phase 4 | |
Completed |
NCT01809288 -
Identifying Risk for Diabetes and Heart Disease in Women
|
||
Completed |
NCT04642482 -
Synbiotic Therapy on Intestinal Microbiota and Insulin Resistance in Obesity
|
Phase 4 | |
Terminated |
NCT03278236 -
Does Time Restricted Feeding Improve Glycaemic Control in Overweight Men?
|
N/A | |
Not yet recruiting |
NCT06159543 -
The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes
|
N/A | |
Not yet recruiting |
NCT05540249 -
Pre-operative Carbohydrates in Diabetic Patients Undergoing CABG
|
N/A | |
Withdrawn |
NCT04741204 -
Metformin Use to Reduce Disparities in Newly Diagnosed Breast Cancer
|
Phase 4 |