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

Insulin Resistance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03090997
• Other study ID #: 3210-10209-01-574-17
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 15, 2018
• Est. completion date: February 28, 2022

Study information

• Verified date: December 2021
• Source: Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: February 28, 2022
• Est. primary completion date: January 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance
• Postmenopausal

Intervention

Dietary Supplement:
• vitamin C (500 mg / day) + placebo
Adminstration of vitamin C (500 mg / day/orally) + placebo (same presentation like resveratrol)
• resveratrol (500 mg / day) + placebo
Adminstration of resveratrol (500 mg / day/orally) + placebo (same presentation like vitamin C)
• vitamin C (500 mg / day) and resveratrol (500 mg / day)
Adminstration of resveratrol (500 mg / day/orally) + vitamin C 500 mg/day/orally)

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Perinatología Isidro Espinosa de los Reyes	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin resistance	Insulin resistance measured by HOMA (Homeostatic Model Assessment)	HOMA at 3 months after starting the intervention in each group
Secondary	Superoxide dismutase activity	Enzymatic activity measured by spectrophotometry	three months after starting the intervention
Secondary	Catalase activity	Enzymatic activity measured by spectrophotometry	three months after starting the intervention
Secondary	Glutathione peroxidase activity	Enzymatic activity measured by spectrophotometry	three months after starting the intervention
Secondary	Glutathione reductase activity	Enzymatic activity measured by spectrophotometry	three months after starting the intervention
Secondary	Malondialdehyde	Enzymatic activity measured by spectrophotometry	three months after starting the intervention
Secondary	Carbonylation of proteins	Marker of oxidative stress measured by spectrophotometry	three months after starting the intervention