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Hormonal and metabolic changes because of postmenopause increase body weight, central abdominal fat, alter lipid profile and insulin resistance, those factors increase the risk up to 60% to develop metabolic syndrome, diabetes and cardiovascular diseases. Because there is no efficient antioxidant therapy in postmenopausal women, this study proposes a therapy with resveratrol and vitamin C to increase the total antioxidant capacity; as well as to decrease insulin resistance and in consequence decreased the risk of diabetes, metabolic syndrome and cardiovascular disease
Currently, there are not studies that demonstrate an efficient antioxidant therapy in postmenopausal women, to increase the total antioxidant capacity and to decrease insulin resistance and biochemical parameters of cardio-metabolic risk. Therefore, the aim of this study is to evaluate the effect of the co-administration of resveratrol and vitamin C on insulin resistance and antioxidant capacity by a double-blind randomized clinical trial. A population of 270 postmenopausal women will be studied, stratified into 3 groups:
Group 1: Three-month administration of vitamin C 500 mg daily + placebo Group 2: Three-month administration of resveratrol 500 mg daily + placebo Group 3: Three months administration of vitamin C 500 mg daily and resveratrol 500 mg daily as antioxidant therapy.
All participants will be monitored monthly for a period of 3 months: glucose, insulin, uric acid, Homeostatic Model Assessment (HOMA), total cholesterol (TC), triglycerides (TGC), High density lipoproteins-cholesterol (HDL- C), low density lipoproteins-cholesterol (LDL), blood pressure, body mass index (BMI). The antioxidant efficiency in erythrocytes by the quantification of antioxidant enzymes (superoxide dismutase, catalase, glutathione reductase and glutathione peroxidase), as well as total antioxidant capacity in plasma. In order to corroborate the oxidative damage, the product of the lipoperoxidation malondialdehyde and the carbonylation of proteins will be evaluated by spectrophotometric techniques before and three months after the intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Placebo Comparator | vitamin C (500 mg/day/orally) + placebo |
|
| Group 2 | Placebo Comparator | resveratrol (500 mg/day/orally) + placebo |
|
| Group 3 | Active Comparator | vitamin C (500 mg/day/orally) + resveratrol (500 mg/day/orally) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vitamin C (500 mg / day) + placebo | Dietary Supplement | Adminstration of vitamin C (500 mg / day/orally) + placebo (same presentation like resveratrol) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Insulin resistance | Insulin resistance measured by HOMA (Homeostatic Model Assessment) | HOMA at 3 months after starting the intervention in each group |
| Measure | Description | Time Frame |
|---|---|---|
| Superoxide dismutase activity | Enzymatic activity measured by spectrophotometry | three months after starting the intervention |
| Catalase activity | Enzymatic activity measured by spectrophotometry |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Araceli Montoya-Estrada, PhD | Instituto Nacional de PerinatologÃa Isidro Espinosa de los Reyes | Principal Investigator |
| Guillermo F Ortiz-Luna, MD | Instituto Nacional de PerinatologÃa Isidro Espinosa de los Reyes | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Nacional de PerinatologÃa Isidro Espinosa de los Reyes | Mexico City | 11000 | Mexico |
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Randomized Clinical Trial
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Participant, care provider, investigator and outcomes assesor will be masking using placebo for resveratrol and vitamin C, the three groups will receive the same intervention with the use of placebo. The placebo will be prepared for the Pharmacology Department and packing and label for exclusive use into the protocol study. Any participant, care provider or investigator will know if package content vitamin C, resveratrol or placebo.
| resveratrol (500 mg / day) + placebo | Dietary Supplement | Adminstration of resveratrol (500 mg / day/orally) + placebo (same presentation like vitamin C) |
|
| vitamin C (500 mg / day) and resveratrol (500 mg / day) | Dietary Supplement | Adminstration of resveratrol (500 mg / day/orally) + vitamin C 500 mg/day/orally) |
|
| three months after starting the intervention |
| Glutathione peroxidase activity | Enzymatic activity measured by spectrophotometry | three months after starting the intervention |
| Glutathione reductase activity | Enzymatic activity measured by spectrophotometry | three months after starting the intervention |
| Malondialdehyde | Enzymatic activity measured by spectrophotometry | three months after starting the intervention |
| Carbonylation of proteins | Marker of oxidative stress measured by spectrophotometry | three months after starting the intervention |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| D000077185 | Resveratrol |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
| D000081225 | Stilbestrols |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D059808 | Polyphenols |
| D010636 | Phenols |
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