Insulin Resistance, Postmenopausal
Conditions
Keywords
resveratrol, vitamin C, antioxidant therapy, antioxidant capacity
Brief summary
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
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTvitamin C (500 mg / day) + placebo
Adminstration of vitamin C (500 mg / day/orally) + placebo (same presentation like resveratrol)
DIETARY_SUPPLEMENTresveratrol (500 mg / day) + placebo
Adminstration of resveratrol (500 mg / day/orally) + placebo (same presentation like vitamin C)
DIETARY_SUPPLEMENTvitamin C (500 mg / day) and resveratrol (500 mg / day)
Adminstration of resveratrol (500 mg / day/orally) + vitamin C 500 mg/day/orally)
Sponsors
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
Randomized Clinical Trial
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Women diagnosed with early postmenopause according to STRAW classification. * Insulin resistance determinated by HOMA ≥ 2.5. * Not use of metformin, bezafibrates and / or statins, three months before enter to the study * No indication of hormone replacement therapy. * Sign the informed consent.
Exclusion criteria
* Women who present pathologies such as: Diabetes Mellitus, rheumatoid arthritis, lupus, neoplasms of any type, HIV, or kidney disease during the course of the study. * Women who during the development of the protocol require hormone replacement therapy. * Any type of surgical intervention during the following of the study. * That the patient wishes to withdraw from the study. * That the patient does not complete with 80% of adherence to the treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insulin resistance | HOMA at 3 months after starting the intervention in each group | Insulin resistance measured by HOMA (Homeostatic Model Assessment) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Catalase activity | three months after starting the intervention | Enzymatic activity measured by spectrophotometry |
| Glutathione peroxidase activity | three months after starting the intervention | Enzymatic activity measured by spectrophotometry |
| Superoxide dismutase activity | three months after starting the intervention | Enzymatic activity measured by spectrophotometry |
| Malondialdehyde | three months after starting the intervention | Enzymatic activity measured by spectrophotometry |
| Carbonylation of proteins | three months after starting the intervention | Marker of oxidative stress measured by spectrophotometry |
| Glutathione reductase activity | three months after starting the intervention | Enzymatic activity measured by spectrophotometry |
Countries
Mexico
Outcome results
None listed