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

NCT03090997 | Unknown DMC

• 1 other identifier: 3210-10209-01-574-17
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Conditions

Postmenopausal; Insulin Resistance

Keywords

resveratrol, vitamin C, antioxidant therapy, antioxidant capacity

Outcome Measures

Primary Outcomes (1)

• Insulin resistance

  Insulin resistance measured by HOMA (Homeostatic Model Assessment)

  HOMA at 3 months after starting the intervention in each group

Secondary Outcomes (6)

• Superoxide dismutase activity

  three months after starting the intervention

• Catalase activity

  three months after starting the intervention

• Glutathione peroxidase activity

  three months after starting the intervention

• Glutathione reductase activity

  three months after starting the intervention

• Malondialdehyde

  three months after starting the intervention

Study Arms (3)

Group 1

PLACEBO COMPARATOR

vitamin C (500 mg/day/orally) + placebo

Dietary Supplement: vitamin C (500 mg / day) + placebo

Group 2

PLACEBO COMPARATOR

resveratrol (500 mg/day/orally) + placebo

Dietary Supplement: resveratrol (500 mg / day) + placebo

Group 3

ACTIVE COMPARATOR

vitamin C (500 mg/day/orally) + resveratrol (500 mg/day/orally)

Dietary Supplement: vitamin C (500 mg / day) and resveratrol (500 mg / day)

Interventions

vitamin C (500 mg / day) + placebo DIETARY_SUPPLEMENT

Adminstration of vitamin C (500 mg / day/orally) + placebo (same presentation like resveratrol)

Group 1

resveratrol (500 mg / day) + placebo DIETARY_SUPPLEMENT

Adminstration of resveratrol (500 mg / day/orally) + placebo (same presentation like vitamin C)

Group 2

vitamin C (500 mg / day) and resveratrol (500 mg / day) DIETARY_SUPPLEMENT

Adminstration of resveratrol (500 mg / day/orally) + vitamin C 500 mg/day/orally)

Group 3

Eligibility Criteria

• Age: 50 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes: lead

Study Sites (1)

Instituto Nacional de Perinatología Isidro Espinosa de los Reyes

Mexico City, 11000, Mexico

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

Ascorbic Acid; Resveratrol

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polyphenols; Phenols

Study Officials

• Araceli Montoya-Estrada, PhD

  Instituto Nacional de Perinatología Isidro Espinosa de los Reyes

  PRINCIPAL INVESTIGATOR

• Guillermo F Ortiz-Luna, MD

  Instituto Nacional de Perinatología Isidro Espinosa de los Reyes

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Randomized Clinical Trial

Study Record Dates

• First Submitted: March 16, 2017
• First Posted: March 27, 2017
• Study Start: February 15, 2018
• Primary Completion: January 30, 2022
• Study Completion: February 28, 2022
• Last Updated: December 28, 2021

Record last verified: 2021-12

Locations

ME (1)