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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Insulin Resistance; Postmenopausal
• Intervention / Treatment: Dietary supplement: vitamin C (500 mg / day) + placebo; Dietary supplement: resveratrol (500 mg / day) + placebo; Dietary supplement: vitamin C (500 mg / day) and resveratrol (500 mg / day)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico, 11000
    • Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Group 1; vitamin C (500 mg/day/orally) + placebo	Dietary supplement: vitamin C (500 mg / day) + placebo; Adminstration of vitamin C (500 mg / day/orally) + placebo (same presentation like resveratrol)
PLACEBO_COMPARATOR: Group 2; resveratrol (500 mg/day/orally) + placebo	Dietary supplement: resveratrol (500 mg / day) + placebo; Adminstration of resveratrol (500 mg / day/orally) + placebo (same presentation like vitamin C)
ACTIVE_COMPARATOR: Group 3; vitamin C (500 mg/day/orally) + resveratrol (500 mg/day/orally)	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
• Investigators: Study Chair: Guillermo F Ortiz-Luna, MD, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 15, 2018
• Primary Completion (ANTICIPATED): January 30, 2022
• Study Completion (ANTICIPATED): February 28, 2022

Study Registration Dates

• First Submitted: March 16, 2017
• First Submitted That Met QC Criteria: March 21, 2017
• First Posted (ACTUAL): March 27, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 28, 2021
• Last Update Submitted That Met QC Criteria: December 24, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: resveratrol, vitamin C, antioxidant therapy, antioxidant capacity
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Protective Agents; Micronutrients; Antioxidants; Vitamins; Ascorbic Acid; Resveratrol
• Other Study ID Numbers: 3210-10209-01-574-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No