Clinical trial NCT03090997: Effect of Resveratrol and Vitamin C on Insulin Resistance Among Postmenopausal Women
Official title: Effect of Resveratrol and Vitamin C on Insulin Resistance and Antioxidant Capacity in Postmenopausal Women. A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postmenopausal
Insulin Resistance
Keywords: resveratrol, vitamin C, antioxidant therapy, antioxidant capacity
Lead sponsor: Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Sponsor class: OTHER_GOV
First posted: 2017-03-27
Enrollment: 45
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Clinical Trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Insulin resistance
timeFrame: HOMA at 3 months after starting the intervention in each group
Secondary outcomes:
measure: Superoxide dismutase activity
timeFrame: three months after starting the intervention
measure: Catalase activity
timeFrame: three months after starting the intervention
measure: Glutathione peroxidase activity
timeFrame: three months after starting the intervention
measure: Glutathione reductase activity
timeFrame: three months after starting the intervention
measure: Malondialdehyde
timeFrame: three months after starting the intervention
measure: Carbonylation of proteins
timeFrame: three months after starting the intervention
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Perinatología Isidro Espinosa de los Reyes
Study officials:
affiliation: Instituto Nacional de Perinatología Isidro Espinosa de los Reyes
name: Araceli Montoya-Estrada, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Nacional de Perinatología Isidro Espinosa de los Reyes
name: Guillermo F Ortiz-Luna, MD
role: STUDY_CHAIR
References: