Regulation of Intestinal and Hepatic Lipoprotein Secretion by Resveratrol

NCT01451918 | Completed Phase 2

• 1 other identifier: RESV10-0537-A
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Dyslipidaemia; Insulin Resistance

Keywords

Dyslipidaemia; Insulin resistance; Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Assess the change in insulin sensitivity with resveratrol treatment

  2 weeks

Study Arms (2)

Resveratrol

ACTIVE COMPARATOR

Drug: Resveratrol

Placebo

PLACEBO COMPARATOR

Drug: Resveratrol

Interventions

Resveratrol DRUG

500mg bid for one week followed by 1 gram bid for one week prior to lipoprotein study.

Placebo; Resveratrol

Eligibility Criteria

• Age: 23 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, Canada

Location

Related Publications (1)

• Dash S, Xiao C, Morgantini C, Szeto L, Lewis GF. High-dose resveratrol treatment for 2 weeks inhibits intestinal and hepatic lipoprotein production in overweight/obese men. Arterioscler Thromb Vasc Biol. 2013 Dec;33(12):2895-901. doi: 10.1161/ATVBAHA.113.302342. Epub 2013 Sep 26.

  PMID: 24072699 DERIVED

MeSH Terms

Conditions

Dyslipidemias; Insulin Resistance; Diabetes Mellitus, Type 2

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols

Study Officials

• Gary Lewis, MD

  UHN Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2011
• First Posted: October 14, 2011
• Study Start: October 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: May 6, 2014

Record last verified: 2012-05

Locations

CA (1)