NCT03090997

Effect of Resveratrol and Vitamin C on Insulin Resistance Among Postmenopausal Women

Effect of Resveratrol and Vitamin C on Insulin Resistance and Antioxidant Capacity in Postmenopausal Women. A Randomized Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes · Other Government
• Sex: Female
• Age: 50 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postmenopausal
• Insulin Resistance

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	vitamin C (500 mg / day) + placebo	Adminstration of vitamin C (500 mg / day/orally) + placebo (same presentation like resveratrol)
DIETARY_SUPPLEMENT	resveratrol (500 mg / day) + placebo	Adminstration of resveratrol (500 mg / day/orally) + placebo (same presentation like vitamin C)
DIETARY_SUPPLEMENT	vitamin C (500 mg / day) and resveratrol (500 mg / day)	Adminstration of resveratrol (500 mg / day/orally) + vitamin C 500 mg/day/orally)

Timeline

• Start date: 2018-02-15
• Primary completion: 2022-01-30
• Completion: 2022-02-28
• First posted: 2017-03-27
• Last updated: 2021-12-28

Locations

1 site across 1 country: Mexico