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Resveratrol is a natural polyphenol (a compound containing a phenol functional group) that can be found in many plants. The purpose of this research is to study the effects of resveratrol on the action of insulin (a hormone produced in the body by the pancreas that regulates the amount of sugar in the blood), fat accumulation, and inflammation in the body.
Participants will meet with the study team to discuss dietary recommendations. Each participant will be instructed to follow a standardized diet plan and to avoid vigorous exercise before beginning the study. Participants will be given a 28 day supply of resveratrol capsules (Two 500 mg capsules taken twice a day). A comprehensive study of whole-body insulin action called a pancreatic clamp will be done and small samples of fat and muscle will be taken before and after the administration of resveratrol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resveratrol | Experimental | Each participant will receive a 28 days' supply of resveratrol capsules on day 0. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resveratrol | Drug | 1,000mg twice daily for 28 days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral Insulin Sensitivity (RD) Measured by the Change in Glucose Rates of Disappearance With Resveratrol or Placebo at Baseline and at 4 Weeks. | We will measure peripheral insulin sensitivity by determining the rate of glucose uptake (RD). RD will be measured using a 6 hours stepped pancreatic clamp study procedure under various treatment conditions (eg, resveratrol or placebo). by monitoring changes in the level of a non-radioactive, naturally occurring form of glucose (sugar). | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Endogenous Glucose Production (EGP), With Resveratrol or Placebo at Baseline and at 4 Weeks. | Endogenous glucose production will be used to determine hepatic insulin sensitivity. Rates of EGP (a measure of the body's production of sugar) will be measured using a 6 hour stepped pancreatic clamp procedure under various treatment conditions (eg, resveratrol or placebo), by monitoring changes in the level of a non-radioactive, naturally occurring form of glucose (sugar). |
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Inclusion Criteria:
Exclusion Criteria:
High cholesterol
<4 week history of participation in another drug trial
Severe hypertension
Heart disease
Liver disease of liver abnormalities
Cerebrovascular disease, i.e. stroke
CVD
Seizures
Bleeding disorders
Muscle disease
Cancer
HIV
Hepatitis (all types)
Mentally disabled persons
Pregnant women
Allergies to Novocaine, Lidocaine, Benzocaine
Subjects on the following medications:
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| Name | Affiliation | Role |
|---|---|---|
| Meredith A Hawkins, M.D., M.S. | Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albert Einstein College of Medicine | The Bronx | New York | 10461 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Resveratrol | Each participant received resveratrol, 1,000mg twice daily for 28 days in a randomized, double blinded placebo-controlled fashion. The investigators used a research procedure called a "pancreatic clamp" study to study the effects of Resveratrol. During the clamp procedure, glucose (a sugar) and insulin (a hormone that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism. |
| FG001 | Placebo | Each participant received a supply of placebo (similar in taste and appearance to Resveratrol) twice daily for 28 days in a randomized, double blinded placebo-controlled fashion. The investigators used a research procedure called a "pancreatic clamp" study to study the effects of Resveratrol. During the clamp procedure, glucose (a sugar) and insulin (a hormone that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
We administered a dose of 2 gm/day Resveratrol (RV) or placebo (PL) for 28 days in a randomized, double-blinded study to total of 20 non-diabetic subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | Resveratrol | Each participant received a supply of resveratrol (1,000mg) twice daily for 28 days |
| BG001 | Placebo | Each participant received a supply of placebo (similar in taste and appearance to Resveratrol) twice daily for 28 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Peripheral Insulin Sensitivity (RD) Measured by the Change in Glucose Rates of Disappearance With Resveratrol or Placebo at Baseline and at 4 Weeks. | We will measure peripheral insulin sensitivity by determining the rate of glucose uptake (RD). RD will be measured using a 6 hours stepped pancreatic clamp study procedure under various treatment conditions (eg, resveratrol or placebo). by monitoring changes in the level of a non-radioactive, naturally occurring form of glucose (sugar). | Posted | Mean | Standard Deviation | mg/kg/min | 4 weeks |
|
Through study completion, an average of 4 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Resveratrol | Each participant received a supply of resveratrol (1,000mg) twice daily for 28 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea and vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Meredith Hawkins | Albert Einstein College of Medicine | 7184302903 | 2903 | meredith.hawkins@einstein.yu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 30, 2015 | Jul 19, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007333 | Insulin Resistance |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D006946 | Hyperinsulinism |
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| ID | Term |
|---|---|
| D000077185 | Resveratrol |
| ID | Term |
|---|---|
| D000081225 | Stilbestrols |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
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| 4 weeks |
| Effects of Resveratrol on Skeletal Muscle Mitochondrial Numbers | Skeletal muscle mitochondria numbers were calculated under EM on subjects pre- and post- treatment of either Resveratrol or placebo intervention. | 4 weeks |
| Gene Expression in Whole Fat Tissue , Before and After 4 Weeks' Resveratrol and Placebo. Ratio From Baseline Versus at 4 Weeks | Changes of relative copy number of gene inflammatory markers in whole fat tissue were studied by quantitative, real-time RT-PCR, resveratrol vs. placebo | 4 weeks |
| Muscle Mitochondrial Area | Skeletal Muscle Mitochondria Area Before and After 4 Weeks of Resveratrol/Placebo Treatment | 4 Weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Endogenous Glucose Production (EGP), With Resveratrol or Placebo at Baseline and at 4 Weeks. | Endogenous glucose production will be used to determine hepatic insulin sensitivity. Rates of EGP (a measure of the body's production of sugar) will be measured using a 6 hour stepped pancreatic clamp procedure under various treatment conditions (eg, resveratrol or placebo), by monitoring changes in the level of a non-radioactive, naturally occurring form of glucose (sugar). | Posted | Mean | Standard Deviation | mg/kg/min | 4 weeks |
|
|
|
| Secondary | Effects of Resveratrol on Skeletal Muscle Mitochondrial Numbers | Skeletal muscle mitochondria numbers were calculated under EM on subjects pre- and post- treatment of either Resveratrol or placebo intervention. | Posted | Mean | Standard Deviation | mitochondria number | 4 weeks |
|
|
|
| Secondary | Gene Expression in Whole Fat Tissue , Before and After 4 Weeks' Resveratrol and Placebo. Ratio From Baseline Versus at 4 Weeks | Changes of relative copy number of gene inflammatory markers in whole fat tissue were studied by quantitative, real-time RT-PCR, resveratrol vs. placebo | Posted | Geometric Mean | Standard Deviation | Ratio | 4 weeks |
|
|
|
| Secondary | Muscle Mitochondrial Area | Skeletal Muscle Mitochondria Area Before and After 4 Weeks of Resveratrol/Placebo Treatment | Posted | Mean | Standard Deviation | µm² | 4 Weeks |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 3 |
| 12 |
| EG001 | Placebo | Each participant received a supply of placebo (similar in taste and appearance to Resveratrol) twice daily for 28 days. | 0 | 8 | 0 | 8 | 0 | 8 |
| Diaphoresis, nausea and lightheadedness | Gastrointestinal disorders | Systematic Assessment |
|
| Vasovagal reflex | Nervous system disorders | Systematic Assessment |
|
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| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D059808 | Polyphenols |
| D010636 | Phenols |
| PAI-1_Whole adipose tissue |
|