Status:
COMPLETED
Regulation of Intestinal and Hepatic Lipoprotein Secretion by Resveratrol
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Dyslipidaemia
Insulin Resistance
Eligibility:
All Genders
23-60 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
Subjects will receive resveratrol (Transmax 1 x 500mg tablets bid for one week followed by 2 x 500mg bid for the second week (Biotivia Longevity Biologicals, New York, NY, USA) or placebo and advised ...
Eligibility Criteria
Inclusion
- Men and women, aged 23 to 60 years
- Fasting plasma triglycerides between 2.0 and 5.0 mmol/l
- Body mass index 25 kg/m2 to 35 kg/m2
- Minimum body weight 64kg
- Hemoglobin above 130g/L.
- Research volunteers must be able to provide informed consent and be willing to comply with protocol requirements.
- HOMA-IR (a measure of insulin resistance calculated from fasting blood glucose and insulin) \>4.0.
- .
Exclusion
- Subject has a history of hepatitis/hepatic disease that has been active within the previous two years.
- 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
- Any dehydration or excessive vomiting
- History of diabetes or 75g OGTT indicative of diabetes.
- Cancer or history of cancer
- 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.
- Any active medical illness
- Any laboratory values: AST \> 2x ULN; ALT \> 2x ULN TSH\>5mU/l or \<0.01 mU/l
- 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
- Any current hormonal disorder or history or hormonal disorders
- Any bleeding disorders or autoimmune conditions
- 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
- Current addiction to alcohol or substances of abuse as determined by the investigator.
- Mental incapacity, unwillingness or language barrier precluding adequate understanding or cooperation
- Taking any prescription or non-prescription medications at the time of the study
- Taking any natural health products during the course of the study
- Having donated blood three months prior to and three months post study procedures
- 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.
- If you are breast-feeding or lactating you will be excluded from the study.
- Women taking the oral contraceptive pill will be excluded from the study.
- All current smokers or those who have smoked more than 1 pack per day for 5 years or more.
- Those with ferritin levels below 50 ug/L will be excluded
- Study Participants who experience serious adverse event or who no longer satisfy the inclusion /exclusion criteria during the trial will be withdrawn
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01451918
Start Date
October 1 2011
End Date
September 1 2013
Last Update
May 6 2014
Active Locations (1)
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1
Toronto General Hospital
Toronto, Ontario, Canada